Implant Primary Stability and Ridge Dimensional Changes Utilizing the Osseodensification Protocol
Phase: NA
Conditions: Dental Implants
Sponsor: The University of Texas Health Science Center, Houston

IRB NUMBER: HSC-DB-21-0597 
IRB APPROVAL DATE: 09/12/2023 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Implant Primary Stability and Ridge Dimensional Changes Utilizing the Osseodensification 
Protocol 
 
NCT05283928 
 
Version Date: 09/12/2023 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

IRB NUMBER: HSC-DB-21-0597 
IRB APPROVAL DATE: 09/12/2023 
 
Protocol Title: 
Implant Primary Stability and Ridge Dimensional Changes 
Utilizing the Osseodensification Protocol 
 
Principal 
Investigator: 
Co-Investigators: 
Popi Stylianou DDS, MS 
 
 
Study Coordinator: 
Auco Dang and Audrena Hankins 
 
Population: 
Twenty patients, 22 years or older, that are not systemically 
compromised and nonsmoking. 
Number of Sites: 
One 
 
Study Duration: 
24 weeks 
 
Subject Duration: 
24 weeks 
 
General Information 
 
Implant stability is critical for the success of osseointegration and for immediate loading protocols. 
Surgical instrumentation techniques, implant macrogeometric design, bone quantity and quality all 
affect implant primary stability. In contrast to standard drilling for implant placement, 
osseodensification drilling compacts and auto-grafts bone at the osteotomy walls resulting in increase 
of ridge dimension, higher insertion torque, and in increased temporal bone to implant contact even in 
low density bone. 
 
Background Information 
Studies conducted comparing standard drilling (SD) with osseodensification drilling (OD) show 
significant increase in implant primary and secondary stability with OD. Through surgical compaction 
of bone into marrow space, OD has been found to increase the insertion torque values regardless of 
the type of implant surface (machined versus acid-etched implant surfaces).1 In another study, 
significantly lower insertion torques have been noted when SD was utilized.2 Additionally, through 
histomorphometric analysis, greater bone-to-implant contact (BIC) and bone area fraction occupancy 
(BAFO) has been demonstrated with OD.2 Autologous bone chips have been recorded with greater 
frequency in the OD group compared to the SD group.3 The autologous bone chips acted as 
nucleating surfaces promoting new bone formation resulting in greater implant stability and bone 
density.3 Another study verified the infrequent presence of bone chips in the SD group compared to 
the commonly observed presence of bone chips in the OD groups.4 When clockwise (CW) and 
counterclockwise (CCW) OD was compared, higher volume of bone chips was observed in the CCW 
OD group. Further research has demonstrated increase in ridge dimensions with the OD method. 
Specifically, narrower ridges measuring 1-3 mm at the crest demonstrated the greatest increase in 
width accounting for 2.83± 0.66 mm increase. Greater changed in ridge width were noted at the crest 
versus 10 mm from the crest.5 
Nikola Angelov DDS, MS, PhD, Srinivas Ayilavarapy, BDS, DSc, 
MDS, Chun-Teh Lee DDS, MS, DMSc, Aziz Saqr, DDS 

IRB NUMBER: HSC-DB-21-0597 
IRB APPROVAL DATE: 09/12/2023 
 
 
Hypothesis: 
• Bone Densification protocol does not increase implant primary and secondary stability values 
in 0-6 wks as compared to standard drilling protocol. 
• Bone Densification does not increase ridge dimensions as compared to standard drilling 
protocol. 
• Bone densification does not increase bone volume and density as compared to 
standard drilling protocol. 
• There is no significant difference between bone densification and standard drilling protocols. 
 
Objectives 
 
The aim of this study is to compare ridge dimensional changes between densification and standard 
drilling protocols. Additionally, primary and secondary stability of implants placed by bone densification 
and standard drilling protocols will be compared. A comparison of the insertion torque values 
(measured in Ncm) and temporal (immediate, 3, 6, and 12 weeks) implant stability quotients at 
osteotomies prepared with standard drilling procedures or when subjected to osseodensification 
surgical instrumentation will be performed. Dimensional changes will be measured before and after 
completion of the implant osteotomy, and compared between standard and osseodensification 
surgical instrumentation. Finally, volumetric changes and ridge dimensional changes will be evaluated 
between initial CBCT and 6 months follow-up CBCT. 
 
 
 
Study Design 
 
Twenty patients (we will try to balance male and female population sample if it is possible) in need to 
receive at least 2 dental implants in single-unit or larger span edentulous spaces will be selected. 
Nonsmoking and not systemically compromised patients will be selected. The following scenarios will 
be chosen to rehabilitate the anterior and posterior regions in this study. 
 
- 
If maxilla: 
osplit-mouth, implant insertion to replace anterior or posterior teeth: one side will 
receive osseodensification drilling instrumentation and the other standard drilling. 
Site selection is randomized by coin toss. 
Osame side, adjacent teeth: Site selection will be randomized by coin toss. 
- 
If mandible: 
osplit-mouth or same side surgical instrumentations will be performed, as 
described for maxilla. 
Surgical technique 
 
Final implant (NobelReplace® Conical) and respective bur diameter for either osseodensification 
instrumentation and conventional drilling will be either 3.5 mm, 4.3 mm or 5.0 mm. Implant lengths will 
be from 8.0 up to 13.0 mm. Versah (Fig. 2) and NobelReplace ® Conical implant surgical kit (Fig. 1) 
present burs with identical diameter and instrumentation will be performed so last bur diameter 
matches with chosen implant diameter. When using Versah, counterclockwise drilling will be 
performed in maxilla, and in mandible clockwise drilling. Before surgery, all patients will receive 
intraoral scans and will be subjected to tomographic examination of the edentulous site for virtual 
implant planning, surgical planning, implant selection, and fabrication of a surgical guide with a mark 
on the buccal aspect identifying the middle of the osteotomy. The osseodensification technique will be 
used for comparison with conventional drilling regarding ridge dimensional changes measured with  
a ridge caliber (Krekler Sliding Caliper Round Gauge Dental Instrument) at 

IRB NUMBER: HSC-DB-21-0597 
IRB APPROVAL DATE: 09/12/2023 
 
implantation (T0); and insertion torque (IT) values and implant stability quotients (ISQ) at implantation 
(T0), 3 (T1,) 6 (T2), and at 12 weeks (T3). ISQ will be measured with Osstell ISQ meter. Data will be 
evaluated with paired t-tests. After T0, patients will receive a healing abutment which will be removed 
and repositioned for T1, T2, and T3 evaluations. After 12 weeks patients will be prosthetically restored 
if insertion torque was 35 Ncm and/or ISQ values are 68. After 6 months, follow-up tomographic 
examination will be completed for volumetric analysis. 
 
Study Population 
 
Patients of the Graduate Periodontology clinic requiring implant therapy will be screened and 
selected to participate in the study based on the following inclusion and exclusion criteria: 
 
Inclusion Criteria 
• Adults aged 22 years and older. 
• Patients who understand and agree to this study. 
• Adequate Oral hygiene 
• One or more edentulous spaces, which are 10 weeks or longer after extractions 
• Patients requiring signature from a Legally Authorized Representative (LAR) will be eligible 
to participate in the study 
 
Exclusion criteria: 
• Grafted extraction socket or ridge augmentation procedure utilizing xenogenic bone graft material. 
• Pregnancy as checked via medical history 
• Smoking of more than 5 cigarettes/day. 
• History of alcoholism or drug abuse during the last 5 years. 
• Uncontrolled Hypertension or diabetes. 
• Patient with malignant tumor. 
• Patients on daily dose of steroids. 
• Patients with history of chemotherapy or radiation for the last 12 months. 
 
Study Procedures 
 
Forty implants will be paired and placed in 20 patients using OsseoDensification (OD) 
protocol as test, and using standard drilling (SD) protocol as control. Sites will be randomly 
assigned in comparative patients prior to flap reflection. 
Primary Outcome Measures: 
All ridge dimensions will be measured immediately after flap reflection and after final osteotomy 
preparation: at crest, 5 mm and 10 mm apical from the crest. A surgical guide will be fabricated for 
the implant surgery which will also be marked on the buccal indicating the middle of the osteotomy 
and the ridge dimensions will be measured using the mark as a standard reference. The 
measurements will be completed the day of surgery only. 
Secondary Outcome Measures: 
1. All implants' primary stability will be measured by insertion torque values and by resonance 
frequency analysis (ISQ) immediately after implant placement (T0). Resonance frequency analysis 
will be measured at three weeks (T1), six weeks (T2), and twelve weeks (T3) post implant 
placement. 
2. At 6 months all patients with receive CBCT for volumetric analysis. 
 
Digital radiographs (periapical radiographs PA) will be taken prior to implant placement, post 
placement, and at 6 weeks. Cone beam computer tomography (CBCT) will be obtained prior to 
implant placement for implant planning and fabrication of a surgical guide, and at 6 months post- 
implantation for volumetric analysis. 

IRB NUMBER: HSC-DB-21-0597 
IRB APPROVAL DATE: 09/12/2023 
 
In any incidence of less than 1 mm buccal plate thickness has resulted after bone preparation, bone 
grafting will be done post implant placement and complete implant coverage will be achieved for 
two-stage healing protocol. Cases requiring bone grafting will be excluded from the CBCT analysis 
at 6 months and from 3-week (T1) and 6-week (T2) ISQ readings. Cases requiring two-stage 
healing will also be excluded from 3-week (T1) and 6-week (T2) ISQ readings, but will be included 
in 12-week (T3) ISQ readings at second stage surgery. 
At 12 weeks all patients will receive dental restorations. Implants' restorative phase will be initiated at 
any time resonance frequency analysis become equal or more than ISQ 68. 
 
Why 3 weeks, 6 weeks, and 12 weeks ISQ measurements: 
The lowest value of implant stability is at three weeks after implant placement and it is most 
pronounced in type IV bone. (Barewal et al, Int. JOMI 2003. Sep-Oct; 18 (5) 641-51) 
Implant Stability increases greatly between week 0 and week 6 and showed slow increase between 
week 6 and 6 months. (Jae-Min Kim et al, J. Adv. Prosthodont 2009. March; 1 (1) 31-36). 
Implant stability starts declining after first week and reach its lowest value at three week to start 
increasing in the fourth week. (Markovic et al, OOOOE 2011. November; 112, (5) 557-63) ISQ 
is obtained at 12 weeks to ensure implant stability prior to having implants restored. 
 
Data and Safety Monitoring 
 
Implant therapy, either with standard drilling or osseodensification, has some inherent possible 
complications such as post-operative discomfort, infection, pain, implant failure, swelling and 
bleeding. All clinical protocols currently in effect in the Graduate Periodontology clinic will be 
followed in order to minimize these risks. Currently, all patients, undergoing implant therapy at the 
Graduate Periodontology, receive antibiotics prophylactically, pain medications for management of 
pain and discomfort, steroids as needed to help with edema, and chlorhexidine mouthrinse to 
maintain the surgical sites clean as possible by reducing the bacterial load. In the event of implant 
failure, the implant will be removed, and the site will be grafted for future repeat of the implant 
therapy at the specific area. 
 
Statistics & Computer tomography analysis 
 
Data will be evaluated with paired T-tests. The total number of subjects enrolled in the study will be 
twenty and all eligible subjects will be provided with the opportunity to participate. Termination of the 
trial will be considered only when unexplained implant failures are observed, excluding implant 
failures associated with systemic conditions, infections or other well documented contributing factors 
in the literature. 
 
1.2-D Linear CBCT analysis: we will superimpose the pre- and post- surgical CBCTs. Then 
determine a cross-sectional plane that goes through the long axis of the placed implant and 
is as perpendicular as possible to the buccal/lingual walls for consistent reproduction. We will 
use the selected cross-sectional plane to measure the overall buccolingual width of the ridge 
and assess any ridge dimensional changes. The software automatically finds the best fit for 
superimposition of the CBCT scan which allows for accurate reproducible measurements. 
2.3-D Volumetric CBCT analysis: Superimposition of the CBCTs, as previously explained, 
will be completed first. A box will be used as the region of interest which will encompass the 
implant and the adjacent cortical plates. The shape of the box will be kept the same for 
consistency. The segmented ridge volume within the box will be used to get actual 
volumetric differences. The term segmentation is a radiology term and refers to the inclusion 
of voxels (in this case, alveolar process) that falls within a specified range of CBCT gray 
scale values determined by an operator. 

IRB NUMBER: HSC-DB-21-0597 
IRB APPROVAL DATE: 09/12/2023 
 
Ethics 
 
At the time of initial consult, all eligible subjects will be provided with the opportunity to decide if they 
want to participate in the study. A description will be provided as well as all that will be required by 

IRB NUMBER: HSC-DB-21-0597 
IRB APPROVAL DATE: 09/12/2023 
 
the patient. If they agree to participate, a written consent form will be obtained, and the subject will 
be provided with a copy of the signed consent form. All consent forms will be kept by the Primary 
Investigator in a locked and secured place. 
 
Data handling and record keeping 
 
All participants will be identified by a number and all identifying information will be kept confidential. 
All the data will be collected in a spreadsheet (excel document) under the participant's specific 
number. Only the Primary Investigator will have access to the identifiable information linked to the 
subject's specific number which will be kept in a locked and secured cabinet in room 6477 in the 
Department of Periodontics and Dental Hygiene. 
 
Quality control and assurance 
 
The primary investigator and all co-investigators participating in the study will be calibrated in order 
to ensure proper use of the Ostell ISQ meter and Mitutoyo Digimatic Caliper. The Ostell ISQ meter is 
a device that is used in everyday clinical practice and does not require special training. The 
Mitutoyo Digimatic Caliper is a digital caliper that measures ridge dimensions with accuracy of two 
numbers after the decimal point and does not require special training. The surgical techniques and 
procedures are used on a daily basis and follow all standards of care thus, no special training or 
calibration is necessary. 
 
Publication Plan 
 
All results from our site will be combined and published in a peer review journal as part of a 
multicenter study. 
 
 
ATTACHMENTS 

IRB NUMBER: HSC-DB-21-0597 
IRB APPROVAL DATE: 09/12/2023 
 
 
 
 
Figure 
1: Burs 
from 
the NobelReplace® Conical implant surgical kit. The corresponding 3.5, 4.3 or 5 mm diameter bur 
from Versah kit will be used for sites where osseodensification will be performed. 

IRB NUMBER: HSC-DB-21-0597 
IRB APPROVAL DATE: 09/12/2023 
 
 
 
 
 
Figure 2: Versah burs to be used per implant diameter for soft and hard bone. 
 
 
Products to be used in this project. 
 
Product 
Quantity 
Check if 
Requested 
from Versa 
h 
Osseodensification drills - kit 
4 
X 
Osstell ISQ 
1 
X 
Krekler Sliding Caliper Round Gauge Dental Instrument 
1 
NobelReplace® Conical implants and healing abutments 
40 
Computed Tomographic scans 
20 

IRB NUMBER: HSC-DB-21-0597 
IRB APPROVAL DATE: 09/12/2023 
 
PTFE 4.0 
20 
Lidocaine 
1 
package 
(50) 
 
 
REFERENCES 
 
1) Oliveira PGFP, Bergamo ETP, Neiva R, Bonfante EA, Witek L, Tovar N, Coelho PG. 
Osseodensification outperforms conventional implant subtractive instrumentation: A study in sheep. 
Mater Sci Eng C Mater Biol Appl. 2018 Sep 1;90:300-307. doi: 10.1016/j.msec.2018.04.051. 
2) Alifarag AM, Lopez CD, Neiva RF, Tovar N, Witek L, Coelho PG. Temporal osseointegration: 
Early biomechanical stability through osseodensification. J Orthop Res. 2018 Mar 14. doi: 
10.1002/jor.23893. 
3) Lopez CD, Alifarag AM, Torroni A, Tovar N, Diaz-Siso JR, Witek L, Rodriguez ED, Coelho PG. 
Osseodensification for enhancement of spinal surgical hardware fixation. J Mech Behav Biomed 
Mater. 
2017 May;69:275-281. doi: 10.1016/j.jmbbm.2017.01.020. 
4) Lahens B, Neiva R, Tovar N, Alifarag AM, Jimbo R, Bonfante EA, Bowers MM, Cuppini M, Freitas 
H, Witek L, Coelho PG. Biomechanical and histologic basis of osseodensification drilling for 
endosteal implant placement in low density bone. An experimental study in sheep. J Mech Behav 
Biomed Mater. 2016 Oct;63:56-65. doi: 10.1016/j.jmbbm.2016.06.007. 
Koutouzis, Theofilos, et al. "Alveolar ridge expansion by osseodensification-mediated plastic 
deformation and compaction autografting: A multicenter retrospective study." Implant dentistry 28.4 
(2019): 349-355.