The Assessment of The Volumetric Occlusal Adjustments Required for Michigan Splints Fabricated Using Various Digital Bite Registrations
Phase: NA
Conditions: Temporomandibular Disorders (TMD)
Sponsor: King's College London

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The Assessment of The Volumetric Occlusal  
Adjustments Required for Michigan Splints Fabricated 
Using Various Digital Bite RegistraAons  
  
Full Approval date 23 July 2024  
  
Arwa Ibrahim Alhusban  
  
Protocol details.  
1.1 Protocol Title:  
The Assessment of The Volumetric Occlusal Adjustments Required for Michigan Splints Fabricated 
Using Various Digital Bite Registrations  
1.2 Protocol Version Control  
Version number: (200524)  
Final/draft: final  
Date:31 May 2024  
1.3 Names (titles), roles and contact details:  
Sponsor  

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Name of Sponsoring Organisation: King’s Collage London   
Ñame of Sponsor Representative: Bashir Al-Hashimi* Address: Room 8.11, 8th Floor Melbourne 
House,  
44-46 Aldwych, London, SE1 8WA   
Telephone: +44 (0)2078487306 Fax: N/a  
Email: vpri@kcl.ac.uk   
Chief Investigator   
Name: Arwa Alhusban (Clinical PhD student)  
Address: Floor 18   
Tower Wing, Guy's Hospital London 
Bridge, SE1 9RT Telephone:  
Fax: N/A  
Email: arwa.alhusban@kcl.ac.uk  
  
Name and address of Co-Investigator(s) Supervisor.   
Name: Dr Sherif Elsharkawy (Senior Clinical Lecturer/Hon Consultant in Prosthodontics)  
Address: Room 36, Floor 17  
Tower Wing, Guy's Hospital London 
Bridge, SE1 9RT Telephone:  
Fax:  
Email: sherif.elsharkawy@kcl.ac.uk  
  
Name: Prof. Owen Addison (Professor/Hon Consultant in Restorative Dentistry)  
Address: Room, Floor 17  
Tower Wing, Guy's Hospital London 
Bridge, SE1 9RT Telephone:  
Fax:  
Email: owen.addison@kcl.ac.uk  
  
Sta$s$cian  
  
Name: Dr Jing Kang  
Address: Room FD60, Floor 26, Guys Tower, Guys Hospital, St Thomas Street, London, SE1 9RT 
Telephone: N/a  
Fax: N/a  
Email: j.kang@kcl.ac.uk  
  
Name: Arwa Alhusban (Clinical PhD student)  
Address: Floor 18   
Tower Wing, Guy's Hospital London 
Bridge, SE1 9RT Telephone:  
Fax: N/A  
Email: arwa.alhusban@kcl.ac.uk  
  
   

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2 CI Signature  
The Chief Inves7gator and the RGO (sponsor oﬃce) have discussed this protocol. 
The inves7gators agree to perform the inves7ga7ons and to abide by this protocol.  
The inves7gator agrees to conduct the study in compliance with the approved protocol, GCP, the UK 
General Data Protec7on Regula7on and Data Protec7on Act (2018), the Sponsor’s SOPs, and any other 
local or external regulatory requirements as required.  
  
Chief inves$gator  
Arwa Alhusban  
   
Signature  
Date  
  
  
  
Contents (update page number as appropriate)  
 1.1  
Protocol Title: ......................................................................................................................... 2  
 1.2  
Protocol Version Control ........................................................................................................ 2  
 1.3  
Names (7tles), roles and contact details: .............................................................................. 2  
2 
CI Signature .................................................................................................................................... 3  
Contents ................................................................................................................................................. 
4  
3 
Summary/Synopsis ........................................................................................................................ 7  
4 
Introduc7on .................................................................................................................................... 
8  
5 
Study/Trial objec7ves and purpose ............................................................................................. 12  
5.1 
Research hypothesis ............................................................................................................ 12  
5.2 
Primary objec7ves ............................................................................................................... 12  
5.3 
Secondary objec7ves ........................................................................................................... 12  
6 
Study/Trial design & Flowchart ................................................................................................... 12  
6.1 
Study/Trial Design ................................................................................................................ 
12  
6.2 
ﬂowchart ………………………………………………………………………………………………………………………..15  
7 
Par7cipant selec7on .................................................................................................................... 15  

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7.1 
Par7cipant 
inclusion 
criteria 
............................................................................................... 15  
7.2 
Par7cipant exclusion criteria .............................................................................................. 15  
8 
Study/Trial procedures ................................................................................................................ 16  
8.1 
Par7cipant recruitment ....................................................................................................... 16  
8.2 
Screening Procedures .......................................................................................................... 16  
8.3 
Randomisa7on Procedures (if applicable) ........................................................................... 16  
8.4 
Blinding & other measures taken to avoid bias (if applicable) ............................................ 16  
8.4.1 
Blinding 
......................................................................................................................... 16  
8.4.2 
Other measures taken to minimise/avoid bias 
............................................................... 16  
8.5 
Interven7on Procedures ...................................................................................................... 16  
 8.7  
End of Study/Trial Deﬁni7on ................................................................................................ 17  
10 Approvals 
...................................................................................................................................... 
17  
11 Safety & Adverse Events Repor7ng ............................................................................................. 17  
11.1 
Assessment of Safety ........................................................................................................... 17  
12 Compliance and withdrawal ......................................................................................................... 17  
12.1 
Par7cipant compliance ........................................................................................................ 17  
12.2 
Withdrawal / dropout of par7cipants .................................................................................. 17  
13 Data 
.............................................................................................................................................. 
17  
13.1 
Data to be collected ............................................................................................................. 17  
13.2 
Data handling and record keeping ........................................................................................ 17  
13.3 
Access to the dataset .......................................................................................................... 18  
14 Sta7s7cal considera7ons ............................................................................................................ 18  
14.1 
Sample size calcula7on ........................................................................................................ 18  

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14.2 
Sta7s7cal 
analysis 
.............................................................................................................. 18  
14.3 
Interim analysis and data monitoring .................................................................................. 18  
 
14.3.1  
Stopping/ discon7nua7on rules and breaking of randomisa7on code ........................... .  
15 Ethical considera7ons .................................................................................................................. 19  
16 Risk Management & Safeguarding ................................................................................................ 
19  
16.1 
Risk Management ................................................................................................................. 19  
16.2 
Safeguarding ........................................................................................................................ 19  
17 Financing 
....................................................................................................................................... 
19  
18 Insurance 
...................................................................................................................................... 
19  
19 Publica7on and Dissemina7on ...................................................................................................... 
20  
19.1 
Publica7on 
............................................................................................................................ 
20  
19.2 
Informing par7cipants ......................................................................................................... 20  
20 Disclosure of Interests ................................................................................................................. 20  
  
    
 

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3  
Summary/Synopsis  
  
Full Title   
Assessment Of the Volumetric Occlusal Adjustments Required For  
Michigan Splints Fabricated Using Various Digital Bite Registrations.  
  
Short Title/Acronym  
DIGI-OCCLUDE  
Protocol Version number and Date  
200524 – 31/5/2024  
REMAS Number  
43439  
REC Name  
Kings College London Research Ethics Committee  
Study registration details (if applicable)  N/A  
Chief Investigator  
Arwa Alhusban  
Sponsor name  
King’s College London  
Funder(s)  
The Hashemite University of Jordan  
Population under investigation  
Healthy Volunteers   
Design & Methodology  
Type of study/trial: controlled, Interventional  
Study Duration  
12 months   
Primary objective  
To evaluate volumetric changes on the biting surface of the occlusal splint 
following four different fully digital workflows. This will indicate the 
accuracy of the techniques in capturing the bite registration.    
Secondary objective(s)  
  
Number of Participants  
40  
Endpoints  
Using the digital facebow along with the digital record of occlusion 
(retruded articular position (RAP) versus intercuspal position (ICP)) will 
result in less modification at the fit appointment.  
Main Inclusion Criteria  
Able to provide an informed consent and having no more than one tooth 
missing per quadrant.  
Main Exclusion Criteria  
 Participants who are Edentulous or wearing partial dentures   
Statistical Methodology and Analysis  
ANOVA statistical test will be used to compare means across the 4 
groups. If the mean values between the comparison values between the 
groups are statistically significant or not.  
Data to be collected & associated 
storage arrangements.  
Baseline data, including intraoral scans, clinical photographs, and digital 
facebow, will be obtained for each participant. This data will serve as a 
reference for both digital and semi-digital occlusal assessments. The data 
will be processed under the terms of UK data protection law (including 
the UK General Data Protection Regulation (UK GDPR) and the Data 
Protection Act 2018).   
  
  
  

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4  
Introduc7on  
  
Temporomandibular disorder (TMD) is significant public health condition affecting the movement of 
the lower jaw and is mainly due to teeth grinding during sleep or sometimes by teeth clenching during 
the day. It can manifest as pain around the ear, clicking sounds when moving your jaw, wear of dental 
tissues, headaches, difficulty in mouth opening, and sometimes jaw locking. Those symptoms usually 
get worse when the patients are under stress. It is not usually serious and generally gets better on its 
own, however in many cases, it requires further consideration. Management of this disordering, soft 
diet, painkillers, physical joint exercises., Furthermore, for many cases, dentist may decide to fabricate 
an occlusal splint (Michigan splints) that fits in the upper teeth, to prevent further damage to the teeth 
and it may help with pain relief, as it positions the joint in a comfortable position. 
 
 
 
Traditionally, these devices are fabricated by taking impressions in the clinic for both jaws and pouring 
these impressions in the lab, waxing up then fabricating the occlusal splints. Dental treatment can be a 
lengthy and expensive process for the dental technician, the dentist, and the patient. Therefore, it is 
important to understand the production accuracy, cost, and reproducibility of newly introduced digital 
methods. Following the design of the dental prosthesis, the prosthesis must be adjusted manually with 
use of a mechanical articulator increasing both cost and time. Thanks to the improved advancements in 
dental technology, dentists can use virtual reality in recording and analysing static and dynamic 
occlusion as well as jaw relation.  
  
Review of literature   
 Occlusion: is defined as the static relationship between the incising or masticating surfaces of the 
maxillary or mandibular teeth or tooth analogues and it’s considered a critical component for diagnosing 
and executing a prosthodontic treatment plan, using either conventional or digital methods.1  
Clinical treatment often requires modifications to the dental occlusion for restorative or prosthetic 
practice.2,3 even though most patients adapt to their new occlusion easily, some can develop discomfort 
and pain, mostly in the presence of an occlusal interference4; Irregular occlusal contacts can lead to 
congestion of the teeth and the appearance of various clinical symptoms, such as migration of the teeth, 
cracked enamel, darkening of the teeth, atrophy of periodontal tissue, gingival recession, defects in 
filling or crowns, osteoarthritis of implants, diseases of the TMJ, migraine, and orofacial 
pain.5,6,7.Therefore, occlusion analysis systems should meet minimal accuracy standards to detect, 
quantify, and locate occlusal contacts.   

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A common way to record the occlusal contacts is the articulating paper which 
is rapid ,affordable and available in different thicknesses.8,9 Another way is the 
silicone occlusal registration, scanned with a light source and analysed by using an image software 
program, has reported to offer the highest reliability and validity for determining the occlusal contact 
area (OCA)10,11  and its claimed to be the ideal and standard  method.12.Recently introduced digital 
systems, including the T-Scan and digital casts, have also become available for occlusal 
assessment.13And their application in oral rehabilitation represents a significant advancement in 
dentistry. This technology leverages digital tools to analyse and plan occlusal relationships, contributing 
to more precise and personalized oral rehabilitation outcome.  The mechanical articulator is a physical 
instrument that facilitates reproduction of the relationship between the jaws and the skull base, as well 
as mandibular articulation, in relation to each of the three spatial planes. With improvements in 
technology, the articulator is shifting from a mechanical device to its digital alternative, the virtual 
articulator which involves software tools. 14A virtual articulator is a computer software tool that can 
reproduce the relationship between the jaws and simulating jaw movement. It has gradually gained 
research interest in dentistry over the past decade. In prosthodontics, the virtual articulator should be 
considered as an additional diagnostic and treatment planning tool to the mechanical articulator, 
especially in complex cases involving alterations to the vertical dimension of occlusion (OVD). To 
correctly simulate jaw movement, the jaw models must be digitalized and properly mounted on the 
virtual articulator.15  
The main indication for the virtual articulator is to overcome the main issues with the mechanical 
articulator, such as creation of new occlusal contacts, material deformation, errors during orientation 
and positioning of dental casts, and difficulties simulating patient data in three dimensions. Those 
articulators may also be used as an educational tool to display treatment options to patients.16 Mounting 
casts on an articulator is necessary for the diagnosis of malocclusion and allows an assessment of 
occlusal alterations during the treatment planning phase. The essential elements common to all available 
virtual articulator are data acquisition and transfer of the arches to the virtual environment, and 
subsequent articulation of virtual models which  includes (1) digital impression of the arches by the 
intraoral scanning ; (2) recording of static occlusion and excursive movements of the mandible; (3) 
transferring the position of the maxilla relative to the skull by the use of facebow ; and (4) mounting the 
virtual models on the articulator.  
Facebows are essential and a key point in dental treatment, for a very important reasons, relating the 
maxillary arch to the condyles. The use of virtual facebows is a critical aspect of assembling digital 
models in a virtual articulator. During virtual articulator mounting, it is essential to orient the arches 

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with respect to a reference plane from the patient’s head; using a virtual facebow is 
used. As the mechanical facebows, virtual facebows can be categorized using 
average values or by kinematics. Prior  

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toits use the clinician needs to identify a reference plane. Any such reference plane 
passes through three points: two at the posterior, and one at the anterior. The two 
posterior landmarks (arbitrary or anatomical) determine a terminal transverse hinge axis. Kinematic 
facebows involve the identification of the rotational hinge axis using cutaneous landmarks to pinpoint 
anatomical condylar projections and can therefore be more precise.17  
When using a kinematic facebow, the possible inclination of the bow in the frontal plane should be 
considered. In the literature, different methods have been reported for transferring the position of the 
arches and carrying out assembly in a virtual articulator These different approaches are based on: 
cephalometric images,18 scanning the position of a marker in six positions with reference to the head 
using a 3D optical scanner,19,20 a series of photographs converted into a 3D face scan,20 digital 
axiography,21 stereophotogrammetry,22 standardized extraoral photographs,23 and calculated cone-beam 
computed tomography (CBCT).24 The advantages of using a facebow are controversial, but it has been 
shown that more precise occlusal contacts can be reproduced in centric jaw relation and eccentric 
movements with a facebow record. In the present trial, we will be using a straightforward and clinically 
applied scanned digital facebow data, to aid in the manufacture of occlusal devices, alongside with two 
different bite registrations such as intercuspal position (ICP) and retruded contact position (RCP). Since 
a little literature is available on the digital aspect of facebows, it is fundamental to understand its 
implementation in the digital workflow in prosthodontics.  
References   
1- The glossary of prosthodontic terms: ninth edition. J  Prosthet  Dent.2017;117:1-5.  
2- ungose S. Geerts G. Analyzing complete denture occlusal contacts: Accuracy and reliability.Int J 
Prosthodont. 2016; 29: 50-52  
3- Prieto-Barrio P. Khoury-Ribas L. Rovira-Lastra B. Ayuso-Montero R. Martinez-Gomis J. Variation in dental 
occlusal schemes two years after placement of single-implant posterior crowns: A preliminary study.J 
Oral Implantol. 2022; 48: 110-116  
4- Avivi-Arber L. Lee J.C. Sessle B.J. Dental occlusal changes induce motor cortex neuroplasticity.J Dent 
Res. 2015; 94: 1757-1764  
5- Mazur M., Jedliński M., Ndokaj A., et al. Long-term effectiveness of treating dentin hypersensitivity with 
Bifluorid 10 and Futurabond U: a split-mouth randomized double-blind clinical trial. Journal of Clinical 
Medicine . 2021;10(10):p. 2085. doi: 10.3390/jcm10102085. [PMC free article] [PubMed] [CrossRef] 
[Google Scholar]  
6- Wang C., Yin X. Occlusal risk factors associated with temporomandibular disorders in young adults with 
normal occlusions. Oral Surgery, Oral Medicine, Oral Pathology, Oral Radiology . 2012;114(4):419–423.  
doi: 10.1016/j.oooo.2011.10.039. [PubMed] [CrossRef] [Google Scholar]  

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7- Chang M., Chronopoulos V., Mattheos N. Impact of excessive occlusal load on 
successfully-osseointegrated dental implants: a literature review. Journal of 
Investigative 
and 
Clinical 
Dentistry 
. 
2013;4(3):142–150. 
doi: 
10.1111/jicd.12036.[PubMed] [CrossRef] [Google Scholar]  
8- Bozhkova T. Musurlieva N. Slavchev D. Dimitrova M. Rimalovska S. Occlusal indicators used in dental 
practice: A survey study.Biomed Res Int. 2021; 20212177385  
9- Brizuela-Velasco A. Álvarez-Arenal Á. Ellakuria-Echevarria J. del Río-Highsmith J. Santamaría-Arrieta G. 
Martín-Blanco N. Influence of articulating paper thickness on occlusal contacts registration: A 
preliminary report.  
Int J Prosthodont. 2015; 28: 360-362  
10- Ayuso-Montero R. Mariano-Hernandez Y. Khoury-Ribas L. Rovira-Lastra B. Willaert E. Martinez-Gomis J.  
Reliability and validity of T-Scan and 3D intraoral scanning for measuring the occlusal contact area.J 
Prosthodont. 2020; 29: 19-25  
11- Kordaß B. Amlang A. Hugger A. Behrendt C. Ruge S. Number and localization of occlusal contact areas 
on natural posterior teeth without dental findings-evaluations of the regional baseline study (SHIP-1) 
with the Greifswald Digital Analyzing System (GEDAS).int J Comput Dent. 2022; 25: 47-56  
12- .Wang Q. Zhao Z. Zhou M. et al.In vivo evaluation of the reliability and validity of three digital occlusion 
analysis methods.J Dent. 2022; 127104355  
13- .Qadeer S. Özcan M. Edelhoff D. VanPelt H. Accuracy, reliability and clinical implications of static 
compared to quantifiable occlusal indicators.Eur J Prosthodont Restor Dent. 2021; 29: 130-141.  
14- Abduo J: Safety of increasing vertical dimension of occlusion: asystematic review. Quintessence Int. 
2012;43:369-380  
15- Lepidi, L., Galli, M., Mastrangelo, F., Venezia, P., Joda, T., Wang, H.-L. and Li, J. (2021), Virtual Articulators 
and Virtual Mounting Procedures: Where Do We Stand?. Journal of Prosthodontics, 30: 24-35  
16- Koralakunte PR, Aljanakh M: The role of virtual articulator in prosthetic and restorative dentistry. J Clin 
Diagn Res. 2014; 8: Ze25-28  
17- Bernhardt O, Küppers N, Rosin M, et al: Comparative tests of arbitrary and kinematic transverse horizontal 
axis recordings of mandibular movements. J Prosthet Dent. 2003; 89: 175-179  
18- Ghanai S, Marmulla R, Wiechnik J, et al: Computer-assisted three-dimensional surgical planning: 3D virtual 
articulator: technical note. Int J Oral Maxillofac Surg. 2010; 39: 75-82  
19- Solaberrieta E, Minguez R, Barrenetxea L, et al: Direct transfer of the position of digitized casts to a virtual 
articulator. J Prosthet Dent. 2013; 109: 411-414  
20- Solaberrieta E, Otegi JR, Minguez R, et al: Improved digital transfer of the maxillary cast to a virtual 
articulator. J Prosthet Dent. 2014; 112: 921-924  
21- Solaberrieta E, Minguez R, Barrenetxea L, et al: Comparison of the accuracy of a 3-dimensional virtual 
method and the conventional method for transferring the maxillary cast to a virtual articulator. J Prosthet 
Dent. 2015; 113: 191-19.  
22- Lam WY, Hsung RT, Choi WW, et al: A 2-part facebow for CAD-CAM dentistry. J Prosthet Dent. 2016; 116: 
843-847.  

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23- Petre A, Drafta S, Stefanescu C, et al: Virtual facebow technique using standardized 
background images. J Prosthet Dent. 2019; 121: 724-728  
24- Lepidi L, Chen Z, Ravida A, et al: A full-digital technique to mount a maxillary arch scan on a virtual 
articulator. J Prosthodont. 2019; 28: 335-338.  
  
5 
Study/Trial objectives and purpose.  
5.1 Research hypothesis.  
  
Null hypothesis: There is no significant difference in the volumetric changes after adjustments between 
different Michigan splints made by different digital bite registration methods.   
5.2 Primary objectives  
To evaluate the volumetric changes on the occlusal surface of the splints after the adjustment done and 
compare these changes before and after in each group.  
5.3 Secondary objectives N/A  
6  
Study/Trial design & Flowchart.  
6.1 Study/Trial Design  
This clinical trial will be conducted on 40 participants, each will receive an occlusal devices according 
to the grouping below. Group   
Group   
Group A  
Group B  
Group C  
Group D  
Criteria   
Without 
digital 
facebow at ICP  
With  
digital 
facebow at ICP  
Without 
digital 
facebow at RAP  
With  
digital  
facebow at RAP  
  
The clinical and the lab steps:  
This clinical trial will need 2 clinical visits:  
VISIT ONE:  
1-Participant information and informed consent.   
Before participation, all participants will be provided with a detailed informed consent form outlining 
the purpose of the study, the procedures involved, potential benefits, and risks. Participants will be given 
the opportunity to ask questions before providing written consent.  
2-Dental photography including Frontal, Right buccal, Left buccal, Upper occlusal, Lower occlusal 
views.  

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3- 
Digital facebow using the AxioSnapMount Facebow-Germany. It 
typically consists of adjustable earpieces and a bite fork, which are attached to the 
patient head, the bite fork is inserted into the patient's mouth, and the patient is guided to bite down into 
occlusion, Once the bite position is scanned, the AxioSnapMount facebow is removed from the patient's 
head. And the data are transferred as STL file into the program.  
4- 
Digital impression of upper and lower teeth using Intraoral Scanner (IOS) (Primescan, 
Sirona). Clinical conditions at the time of scanning the patient will be IOS calibrated before each scan 
according to the manufacture's recommendations, operatory temperature is at room temperature, Optra-
gate will be used to separate the cheeks and saliva suction at the beginning of each arch scan and 
operatory light will be turned off. The IOS start on the occlusal of the maxillary right second molar, 
continues along the occlusal surfaces of the adjacent teeth to the left maxillary second molar, continues 
toward the buccal side of the same left maxillary second molar to the buccal side of the right second 
molar, and ends with a scan of the lingual side of the same molar to the left maxillary second molar, 
continues toward the buccal side of the same left maxillary second molar to the buccal side of the right 
second molar, and ends with a scan of the lingual side of the same molar to the left maxillary second 
molar.  
5- 
Bite registration: A Lucia gauge will be used to separate the maxillary and mandibular teeth 
for 5 minutes to deprogram the muscles of mastication. The participant will be guided to occlude on the 
lucia jig to protrude and perform lateral excursions of the mandible without posterior tooth contacts. 
The position will be recorded with a polyvinylsiloxane occlusal recording material (O-Bite; DMG). 
Then the teeth will be dried with an air syringe to minimize the influence of saliva on scanning accuracy. 
the  intraoral scanner will scan the maxillary and mandibular dentition and the maxillomandibular bite 
relationship in the retruded articular position (RAP). While obtaining the occlusal relationship, the 
occlusal record will be located on one side to scan the teeth on the other side.  
6- 
Another bite record will be taken where teeth meet normal together, as soon as Intercuspal 
position (ICP) and scanned by the IOS.  
LAB PROCEDURE:   
1- All groups will be mounted digitally on average value virtual articulator.  
Group A. Export the scans for the CAD design in Standard Tessellation Language (STL) files and 
processed for virtual mounting the models on virtual articulator with average values. The average 
digital articulator will use average values (Bennett angle=10 degrees; immediate side shift=0.5 mm; 
condylar angle=30 degrees; angle incisal table=30 degrees) as its parameters with the use the ICP 
record.  

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Group B. The scanned facebow fork will be imported and matched to the software 
for the maxillary mount. And the fabrication of the occlusal splint with the ICP 
record.  
Group C.  The models will be mounted using the RAP record only.  
Group D. The models will be mounted using the digital facebow and the RAP record.  
2- Design the occlusal splint based on the patient's specific dental anatomy, considering factors like the bite, 
occlusion, and any specific requirements for the splint.  
3- Printing: load the digital file and a 3D printer Sprintray will be used to print all the digital occlusal 
devices based on the digital design. These digital devices are to be printed from.  
4- Polishing: Apply a biocompatible polish (Sof-Lex™ Finishing and Polishing System by 3M).  
5- Scan the splint by using lab scanner (3 shape E3) the splint with optical spray to overcome the 
translucency issue while scanning (Telescan CAD Spray White).  
  
VISIT 2:  
Patient fitting  
-Try the digital occlusal splint on the patient to ensure a proper fit and make any necessary occlusal 
adjustment.  
-Scan: after the required occlusal adjustments are done, the splints are scanned again.  
The next step:  
The STL files of both scans of the occlusal device will be imported into a reverse engineering software 
program (Geomagic Wrap 2021; 3D Systems), and the root mean square (RMS) values will be used 
to represent the volume of occlusal adjustment and will be obtained by the “best fit alignment” and “3D 
compare” function. the occlusal adjustment positions will be standardized according to the 3D deviation 
scale diagram in the software program.  
  

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  Flowchart  
 
 
 
 
 
Volunteers   
Exclusion  
criteria  
Inclusion  
criteria  
 par7cipants  
Visit  
1  
Par7cipant informa7on  
sheet and consent   
Digital intraoral  
scanning impression  
Group A  
Without DFB  
at ICP  
Group B  
With DFB at  
ICP  
Group  C  
Without DFB at  
R A P  
Group D  
With DFB at  
R A P   
7  
 
 
 
Visit  
2  
Splint ﬁfng  and  
occlusal a djustment  
needed is  done.  
The par7cipant  will not   
recieve  any splint  

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8  
Participant selection   
A recruitment volunteer sheet will be distributed. The recruitment will only occur through the college 
advert and this project does not have any incentives. When they show interest in this project, I will send 
them the consent form. Then they will be given 48 hours to decide if they want to take part before being 
asked to give their consent. Volunteers themselves will need to sign the form. There is no professional 
Word in this project. So, there is no potential language problem.   
  
8.1 Participant inclusion criteria  
• 
Aged between 18 and 65.  
• 
Able to provide informed consent.  
• 
Have no more than one tooth missing per quadrant.  
• 
Not diagnosed with any TMD disorder.  
• 
Not undergoing any active dental treatment.  
• 
Regular attendee to the dentist and have stable dentition and oral health.  
  
8.2 Participant exclusion criteria   
• 
Patients with removable dentures.  
• 
Patients receiving medication for psychological disorders.  
• 
Patients diagnosed with systemic joint disorders.  
• 
Pregnant or lactating women  
• 
Patients who have received TMD treatment in the last 6 months.  
9  
Study/Trial procedures.  
9.1 Participant recruitment  
• 
Recruitment research sheets to advertise about the project and will be distributed and advertised. 
Clinical records will be examined by the to assess eligibility prior to the clinic. Eligible participants 
or those for whom clarification is required will be approached by their contacts to discuss study 
participation. Interested participant will have the study explained to them and be provided with an 
information sheet and given the opportunity to ask questions. Those who agree to take part will then 
have their eligibility confirmed and informed consent taken prior to participation in the trial. 
Following consent, baseline clinical assessments will be performed, and the volunteers randomised. 
We will keep a record of the number approached and the number of participants who are eligible 
and agree to participate in the trial. Reasons for excluding participants and reasons for 
nonparticipation will be recorded.  

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• 
Participant will be gifted with amazon vouchers of 50 pounds.  
9.2 Screening Procedures   
10 All participants that accept to volunteer will be logged into a screening log associated with the 
trial. I will confirm the volunteers’ health conditions through basic communication. If they cannot 
meet the criteria, they will be excluded from this project.   
10.1 Randomization Procedures (if applicable)  
There is no randomisation in this study as all participants will undergo the same process of scanning 
and recording.  
10.2 Blinding & other measures taken to avoid bias (if applicable)  
8.4.1 Blinding.  
The trial cannot be blinded.  
10.2.2 Other measures taken to minimise/avoid bias.  
The scanning will be done by an experienced single operator to all participants with the help of a 
prosthodontic consultant and if needed it will be repeated.  
10.3 Intervention Procedures  
Intraoral scanning and using the facebow to record the maxillary jaw mount.  
Inser7on of occlusal splints, ﬁfng them, and doing the occlusal adjustment needed.  
10.4 End of Study/Trial Definition   
The end of trial is when all data has been collected and the database locked.   
8.7 Approvals  
  
The study protocol and other documentation will be submitted to the King’s College London Research 
Ethics Committee and REMAS before the start of the study.  
All correspondence with the REC will be retained.  
Any amendments to the study will be submitted to the King’s College London Research Ethics 
Committee as a modification request through REMAS. Amendments will not be implemented until a 
favourable opinion is issued.  
11 Compliance and withdrawal  
11.1 Participant compliance  
The participant will be provided by an information sheet explaining the trial procedure and will be asked 
to sign an informed consent.  
  
11.2 Withdrawal / dropout of participants.  

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The participantes are free withdraw at any point of the project, without having to 
give a reason.  
Withdrawing from the project will not affect you in any way. If so, their data Will 
be deleted.  
11.1  protocol compliance.   
Arwa will record non-compliance with the protocol if any happened and will email it to supervisors (Dr 
Sherif Elsharkawy and Prof. Owen Addison)  
12 Data  
  
12.1 Data to be collected.  
Baseline data, including intraoral scans, clinical photographs, and digital facebow, will be 
obtained for each participant. This data will serve as a reference for both digital and semi-digital occlusal 
assessments.  
  
12.2 Data handling and record keeping.  
The data will be processed under the terms of UK data protection law (including the UK General Data 
Protection Regulation (UK GDPR) and the Data Protection Act 2018.  
• 
we are not collecting any personal information besides the name on the consent form.  
• 
the participants and their personal information will not be identified during or after the study.   
• 
The data will be achieved for future records as long as the PhD course.   
• 
The data will only be shared within the research team.  
  
Specialist teams within King’s College London continually assess and ensure that data is held in the 
most appropriate and secure way.  
12.3 Access to the data set  
The data will be accessed by the research team and the dental lab which will design and prepare the 
occlusal splints.  
13 Statistical considerations.  
The sample size should be 30 per each group but because of limited ﬁnance and 7me we decided to 
do 10 per each group.   
  
  
  

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13.1 Sample size calculation.   
  
The par7cipant number will be 40 and 40 splints will be fabricated scanned before and ager the 
adjustment for each group.  
For the best statistics result the sample size should be 30 but because of the limited time as a PhD 
student, limited finance, and recourses. Since the literature had studies on digital facebow as clinical 
reports without comparisons we decided to use 10*4 as the sample size.  
- References Some studies about the volumetric changes using the geoma7c sogware as   
Alvaro et al did the trial with 31 participant each received 2 splints.  
Blasi Á, Henarejos-Domingo V, Palacios-Bañuelos R, Aparicio C, Roig M. Comparison accuracy of digital and analog method 
using milled occlusal splints. J Esthet Restor Dent. 2023 Oct;35(7):1103-1112. doi: 10.1111/jerd.13039. Epub 2023 Mar 21. 
PMID: 36942721.  
Tiwu et al recruited 30 patients and divided them in two groups; each 15 received a different splint (α=.05)  (P>.05)  
Tiwu Peng, Zhikang Yang, Teng Ma, Mindi Zhang, Guanghui Ren,Comparative evaluation of the volume of occlusal 
adjustment of repositioning occlusal devices designed by using an average value digital articulator and the jaw movement 
analyser Journal of Prosthetic Dentistry,2023.  
  
13.2 Statistical analysis  
Recruitment and Retention  
Information on the patients approached to enter the study will be analysed descriptively (Numbers of: 
patients approached, patients eligible, patients randomised, and patients retained). Reasons for nonentry 
into the trial will be assessed. Patient drop-out data will be collected to calculate retention rates and 
identify reasons for non-completion. The number and proportion of participants who did not complete 
the trial overall will be reported. Reasons for non-completion will be analysed descriptively.  
  
13.3 Interim analysis and data monitoring  
13.3.1  Stopping/ discontinuation rules and breaking of randomisation code  
For each volunteer, the complete end point of this project will be the final after fitting the splints and 
doing the occlusal modification needed. After that clinical session they do not need to do any further 
experiments. Premature discontinuation is defined as volunteers get COVID or they want to withdraw 
from the research before the end of the project. They will inform the primary researcher (Arwa 
Alhusban) or the supervisors (Dr. Sherif Elsharkawy and Prof. Owen Addison) and they will be removed 
along with their data if the data have not already been pooled together.   
13.3.2 control and assurance.  

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There is no data monitoring or steering commiiee set up for this project.   
14 Ethical considerations  
This study will adhere to ethical standards, and ethical approval will be obtained from the REMAS.  
15  
Risk Management & Safeguarding  
  
15.1 Risk Management  
No risk to your health or teeth will be applied. Slight discomfort may arise when taking the scans as 
well as during the fitting of the splint and the participant can choose to stop the procedure at any time.  
16 Financing   
This trial is funded by the Hashemite university of Jordan.  
17 Insurance  
The study is sponsored by King’s College London (KCL). The sponsor will, always, maintain 
adequate insurance in relation to the study: KCL through its own professional indemnity (Clinical 
Trials) & no-fault compensation, in respect of any claims arising because of negligence by its 
employees, brought by or on behalf of a trial participant.  
18 Publication and Dissemination  
18.1 Publication  
All inves7gators in the study will have access to raw data and right to publica7on because the raw data 
will be fully anonymous ager publica7on.   
18.2 Informing participants  
When the result of the trial is published whoever interested of the participant in getting the result can 
get them through their email contacts.  
  
19 Disclosure of Interests  
 There are no financial and other competing interests of the Chief Investigator except for research 
purposes.