Digital Occlusal Analysis of Ultra Suction Retained Complete Denture
Phase: NA
Conditions: Complete Edentulism
Sponsor: Badr University

Digital Occlusal Analysis of Ultra Suction 
Retained Complete Denture 
[NCT ID not yet assigned] 
Unique Protocol ID: 1122110085 
Document Date: 15/8/2020 
 
 
 
 
 
 
 
 
 
 
 

 
A. Digital evaluation of mandibular complete denture 
Prior to employing T-Scan occlusal analyzer to assess the occlusion on the 
complete denture, complete denture was seated and checked for fitness, stability, 
pressure areas with pressure indicating paste and border evaluation and extension. 
The peripheral seal should be evident so that the denture-maintained suction against 
maxillary tissues. Upon completion of these fit and stability assessments, the 
occlusion could then be addressed. 
The method considered for the occlusal analysis was a computerized system 
1. The system was composed of a computer with a specific board and software 
capable of converting information recorded by the sensor to visual and numerical 
information on tooth contact. For Tekscan system to function properly, computer 
system must meet or exceed specified system requirements. 
The Tekscan USB handle, does not require an additional interface card or 
parallel box in order to be connected to computer. When inserted into computer, the 
computer`s operating system will automatically detect and configure the hardware 
for use. The T-Scan sensor was an ultra-thin (.004”, 0.1 mm), flexible printed circuit 
that detected the patient`s occlusal parameters. 
 
 
 
                                                          
1Tekscan Corp, Boston, Massachuttes, USA. 

B. Statistical Analysis: 
Data were presented as means and standard deviation (SD) values. The 
comparison between any two groups were done using independent t-test (Student`s 
t-test).  
Statistical analysis was performed with SPSS 20® (Statistical Package for 
Social Science) and Microsoft Excel2010. The significant level was set at P ≤ 0.05. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

1.  KEY INFORMATION ABOUT THE RESEARCHERS AND THIS STUDY   
Study title: Digital Occlusal Analysis of Ultra Suction Retained Complete Denture 
Principal Investigator: [Shady El Naggar, Removable Prosthodontics Department, Badr 
University in Cairo] 
Co-Investigator(s): [Sherihan M. Eissa, Fixed and Removable Prosthodontics Department, 
National Research Center] 
 
You are invited to take part in a research study.  This form contains information that will help you 
decide whether to join the study.  
 
 
A complete denture will be performed according to your edentulous criteria with supporting 
device (Ultra Suction Device). Investigations will be performed by occlusal load analysis using 
Tek-scan device. 
 
1.1 Key Information 
Things you should know: 
 
Biting analysis of conventional complete denture supported by Ultra-suction device. 
 
If you choose to participate, you will be asked to take apart of all manufacturing visits and 
follow up investigations for one year. 
 
Risks or discomforts from this research include mild discomfort with initial commitment of 
appointments. 
 
The direct benefits of your participation is having a good manufactured complete denture 
as best treatment of complete edentulous state. 
 
Taking part in this research project is voluntary. You do not have to participate and you can stop 
at any time. Please take time to read this entire form and ask questions before deciding whether 
to take part in this research project. 
2. PURPOSE OF THIS STUDY 
Digital Occlusal Analysis of Ultra Suction Retained Complete Denture using Tek-scan device 
3. WHO CAN PARTICIPATE IN THE STUDY 
3.1 Who can take part in this study?  
 
1- Age of the selected patients ranged between 60-70 years.  

2- The residual alveolar ridges exhibited adequate height and width, with no bony exostosis or, 
undercuts. 
3- The residual alveolar ridges covered with firm fibrous mucoperiosteum. With no signs of 
inflammation, ulceration or hyperplasia. 
4- The selected patients exhibited Angle class I maxillomandibular relationship, and had adequate 
inter arch space.  
5- Patients were free from any systemic diseases or hormonal disorders that may affect the oral 
condition. 
6- Patients were free from any signs of oral pathology. 
7- Patients had no history of bad habits as clenching and bruxism, they also had no temporo 
mandibular joint disorders. 
8- Patients were nonsmokers and had no previous denture experience. 
9- Patients with excessive salivation were not included in this study. 
 
4.  INFORMATION ABOUT STUDY PARTICIPATION 
4.1 What will happen to me in this study? 
 
The location where research activities/procedures will take place: National research 
center, Dokki, Giza, Egypt. 
 
Biting analysis of conventional complete denture supported by Ultra-suction device. 
 
If you choose to participate, you will be asked to take apart of all manufacturing visits and 
follow up investigations for one year. 
 
Data collection procedures: observational. 
 
Identification of which procedures are standard and which are experimental 
 
Conventional complete denture without supporting devices as a standard procedure and 
conventional complete denture supported by Ultra-suction device as an interventional 
procedure. 
 
Randomization procedures: simple randomization. 
 
Use of medical records: Patient general health will be evaluated through a full medical 
history as well as laboratory investigations. . 
 
4.2 How much of my time will be needed to take part in this study?  
One Year 
 
4.3 If I decide not to take part in this study, what other options do I have?  

There may be other ways of treating your condition if you do not want to be in this research study. 
Check with your health care provider to discuss other options. 
 
 
5.  INFORMATION ABOUT STUDY RISKS AND BENEFITS 
5.1 What risks will I face by taking part in the study?  What will the researchers do to protect 
me against these risks? 
These may be physical, psychological, legal or informational. Breach of confidentiality (i.e., 
informational risks) is a potential risk in all research that collects or maintains personally 
identifiable information and may be the only risk in some studies. The researchers will try to 
minimize these risks 
 
For informational risks state: Because this study collects information about you, [one of the 
risks/the primary risk] of this research is a loss of confidentiality. 
 
5.1.1 What happens if I get hurt, become sick, or have other problems because of this 
research?  
The researchers have taken steps to minimize the risks of this study.  Please tell the researchers 
if you have any injuries or problems related to your participation in the study. The University may 
be able to assist you with obtaining emergency treatment, if appropriate, but you or your insurance 
company will be responsible for the cost. By signing this form, you do not give up your right to 
seek payment if you are harmed because of being in this study.  
 
5.2 How could I benefit if I take part in this study?  How could others benefit?   
You may not receive any personal benefits from being in this study. However, others may benefit 
from the knowledge gained from this study. 
 
5.3 Will the researchers tell me if they learn of new information that could change my 
willingness to stay in this study? 
Yes, the researchers will tell you if they learn of important new information that may change your 
willingness to stay in this study.  
 

6.  ENDING THE STUDY 
6.1 If I want to stop participating in the study, what should I do? 
You are free to leave the study at any time.  If you leave the study before it is finished, 
there will be no penalty to you. If you decide to leave the study before it is finished, please 
tell one of the persons listed in Section 9. “Contact Information”. If you choose to tell the 
researchers why you are leaving the study, your reasons may be kept as part of the study 
record. The researchers will keep the information collected about you for the research 
unless you ask us to delete it from our records. If the researchers have already used your 
information in a research analysis it will not be possible to remove your information. 
 
7.  FINANCIAL INFORMATION 
7.1 Will I be paid or given anything for taking part in this study? You will receive [an 
appropriate compensation] for your participation in the study. 
 
 
 
8. PROTECTING AND SHARING RESEARCH INFORMATION  
 
8.1 How will the researchers protect my information? Through confidential terms. 
 
8.2 Who will have access to my research records? 
There are reasons why information about you may be used or seen by the researchers or others 
during or after this study. Examples include: 
 
University, government officials, study sponsors or funders, auditors, and/or the 
Institutional Review Board (IRB) may need the information to make sure that the study is 
done in a safe and proper manner.    
 
8.3 What will happen to the information collected in this study? 
We will keep the information we collect about you during the research [for future research 
projects/for study recordkeeping or other purposes (describe)]. Your name and other information 
that can directly identify you will be stored securely and separately from the research information 
we collected from you.   
 

8.4 Will my information be used for future research or shared with others? 
 
We may use or share your research information for future research studies. If we share your 
information with other researchers it will be de-identified, which means that it will not contain your 
name or other information that can directly identify you. This research may be similar to this study 
or completely different. We will not ask for your additional informed consent for these studies.  
 
8.4.1 Special Requirements 
If your project meets the definition of an NIH clinical trial, include the following required 
language: A description of this clinical trial will be available on www.ClinicalTrials.gov, as required 
by the National Institutes of Health (NIH). This website will not include information that can identify 
you. At most, the website will include a summary of the results. You can search this website at 
any time.  
 
If you will register your project on ClinicalTrials.gov voluntarily or in order to meet journal 
or other requirements, include the following: This trial will be registered and may report results 
on www.clinicaltrials.gov. This site will not include information that can identify you. At most, the 
website will include a summary of the results. You can search this website at any time. 
 
 
9. CONTACT INFORMATION 
Who can I contact about this study? 
Please contact the researchers listed below to: 
 
Obtain more information about the study 
 
Ask a question about the study procedures 
 
Report an illness, injury, or other problem (you may also need to tell your regular doctors) 
 
Leave the study before it is finished 
 
Express a concern about the study 
 
Principal Investigator: Shady El Naggar 
Email: shady.mahmoud@buc.edu.eg 
Phone: +201122110085 
 

 
 
10. YOUR CONSENT  
Consent/Assent to Participate in the Research Study 
By signing this document, you are agreeing to be in this study. Make sure you understand what 
the study is about before you sign. I/We will give you a copy of this document for your records 
and I/we will keep a copy with the study records.  If you have any questions about the study after 
you sign this document, you can contact the study team using the information in Section 9 
provided above. 
 
I understand what the study is about and my questions so far have been answered. I agree to 
take part in this study.  
 
Print Legal Name: _____________________________________________________ 
 
Signature: ___________________________________________________________ 
 
Date of Signature (mm/dd/yy): ___________________________________________