Implant OsseointegrationNCT07108361
"Osseodensification Efficacy on Molar Septum Expansion in Immediate Molar Implant Placement
A study testing Osseodensification and conventional drilling in people with Implant Osseointegration and Implant Osteotomy, run by Ain Shams University at 2 sites in Egypt.
Trial summary
The ideal positioning of immediate implants in molar extraction sockets often requires the osteotomy to be in the interradicular septum, which can be challenging in some cases, with traditional site preparation techniques. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Implant Osseointegration, Implant Osteotomy, Implant Placement
- What is being tested?
- Osseodensification and conventional drilling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Sep 2025to Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients requiring placement in the posterior region.
- ASA I and II patients who can undergo immediate implant placement and restorative procedures.
- Both males and females.
- Patient's age: 18-50 years old.
- Patients who can come for the follow-up visit.
- Patients who provide written informed consent
Who cannot join
- Pregnancy.
- Smoking
- Patients with previously failed dental implants at the implant placement site.
- Patients with active infections.
- Other medical conditions that might affect the osseointegration of dental implants, such as diabetes, cardiovascular disease, hypertension, and osteoporosis
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt2 sites, 2 recruiting
- Not yet recruiting
Ain Shams University
Cairo
Mohammed Samir Samir, 01144063175, mohamedsamirramadan@dent.asu.edu.eg
- Recruiting
Ain Shams University
Cairo
Mohammed Samir Samir, 01144063175, mohamedsamirramadan@dent.asu.edu.eg
About this study
Official title: "Osseodensification Efficacy on Molar Septum Expansion in Immediate Molar Implant Placement: A Randomized Controlled Clinical Trial
The ideal positioning of immediate implants in molar extraction sockets often requires the osteotomy to be in the interradicular septum, which can be challenging in some cases, with traditional site preparation techniques. Also, the alveolar ridge undergoes various remodeling processes following tooth extraction, resulting in hard and soft tissue loss which complicates prosthodontic rehabilitation. Immediate implant placement help preserve the alveolar ridge dimensions and buccal ridge contour. While osseodensification has shown promise in enhancing primary stability and bone microarchitecture, its clinical and microstructural effects in molar extraction sockets remain underexplored. Although there is ample documentation of information on the temperature that is generated during preparation of implant sites, there are no studies available in the literature comparing conventional drilling and osseodensification techniques; therefore, the present investigation was aimed at analyzing the efficacy of osseodensification compared to conventional drilling in terms of bone dimensions preservation , changes in bone architecture during implant site preparation and heat generation to define which technique can be safely applied to achieve the necessary implant primary stability without damaging the surrounding bone.
Aim of the study:
Is to compare the molar septum dimensions using osseodensification expansion versus the conventional drilling protocol and to assess the role of jumping gap grafting in preservation of the alveolar ridge dimensions and buccal ridge contour in addition to Evaluation of the effect of osseodensification on the bony micro-architecture and heat generation
Read the detailed description
The proposed study consists of two arms: 1- Clinical arm, 2- Ex-Vivo arm
The clinical arm:
80 patients with hopeless teeth requiring extraction in the molar region and requiring replacement with dental implants, will be enrolled and recruited from the outpatient clinic, faculty of dentistry, Ain shams university according to the inclusion criteria. They will be randomly allocated into two equal groups. 40 patients in the osseodensification group and 40 patients in the conventional drilling group. Each group will be further subdivided into two groups with and without jumping gap graftingPerioperative and postoperative CBCT will be ordered, and perioperative and postoperative impressions will be made and scanned for each patient to prepare a virtual 3D model before extraction and after extraction and implant placement. Molar septum dimensions will be compared before and after implant placement in addition to evaluation of vertical and horizontal alveolar bone changes and changes in bone density after placement of immediate implant in extraction socket, also a volumetric analysis will be made to assess the changes in the buccal ridge contour before and after implant placement with and without grafting of the jumping gap. Clinical outcomes will be assessed including (success and survival of implants, insertion torque, ISQ values, Probing depth, modified pink esthetic score, KTW, and patient satisfaction) all the outcomes will be assessed as baseline before the implant placement and will be followed up at 0,6 and 12 months after implant placementThe Ex-Vivo arm: study will be conducted in an ex vivo animal model using porcine bones. The animals won't be used exclusively for this study and the bones will be collected as if it was disposable as waste material, so ethical approval will not be necessary. Both tibias of a single skeletally mature porcine will be collected on the day of the slaughter. To prepare the samples, approximately 15 mm of the articular surface and subchondral bone will be removed by transversely sectioning the bones, thereby exposing the medullary portion. Three canals for thermocouples at three different depths (2 mm: T1-cortical bone, 7.5 mm: T2-cancellous bone, and 10.5 mm: T3- deep cancellous bone) from the crest of the pig bone will be drilled using 1.5 mm twist drill perpendicularly to each implant site preparation and using intermittent cutting to a distance approximately 1 mm from the planned osteotomy site.The thermocouples will be secured to the bone blocks at a distance of approximately 1 mm from the future osteotomy and insulated using sticky wax at the canal opening This study will be performed on 12 samples removed from the tibias, divided into two groups according to the drilling technique: a control group of the conventional technique (CT) (n=6), and a test group of osseodensification (OD) (n=6). The evaluation of bone microstructure using Micro-CT will follow the guidelines proposed by Bouxsein et al. (2010), which includes the use of terminologies, procedures, images, and reporting of the results. The thermocouples will be connected to a digital thermometer that allows continuous temperature reading, and temperature changes (baseline and final temperature readings) during the osteotomy preparation will be recorded for statistical analysis
- Conditions
- Implant Osseointegration, Implant Osteotomy, Implant Placement, Implant Primary Stability, Molar Extraction Socket, Immediate Implant Placement
- Being tested
- Osseodensification, conventional drilling
- Keywords
- non restorable tooth, molar extraction, multirooted teeth, extraction socket, immediate Implant placement, Osseodensification, ex-vivo, RCT, Jumping gap, Grafting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OsseodensificationProcedure or surgery
Septum width will be directly measured post molar extraction confirming the premeasure of the CBCT. Measurement will be recorded at the narrowest width of the septum. Implant site preparation starts with a pilot drill, in clockwise motion, in the center of the septum, until 1 mm deeper than the planned implant length. Densah® Burs (Versah, LLC, Jackson, MI, USA) were then sequentially used in OD mode (counterclockwise, drilling speed 800-1500 rpm, with copious irrigation) in small increments to gradually expand the osteotomy, until reaching the desired width for the planned implant diameter, Osteotomy diameter as a reflection of septum width expansion will then be directly measured and recorded after site instrumentation. Implants of adequate diameter (4, 4.5, or 5mm) and length (selected using preoperative CBCT) will be inserted in the prepared osteotomies to engage the bone apical to the socket, insertion torque will be measured using the torque wrench and ISQ values
conventional drillingProcedure or surgery
Septum width will be directly measured post molar extraction confirming the premeasure of the CBCT. Measurement will be recorded at the narrowest width of the septum. The initial (pointed) drill will be used to make a hole (starting point) in the interradicular bone to avoid slippage of the subsequent the drills in the socket of the remaining roots. The drills of increasing diameters will be used to complete the implant osteotomy according to manufacturer instructions. In case of limited interradicular bone volume, drilling will be made at the socket of mesial or distal roots. Osteotomy diameter as a reflection of septum width expansion will then be directly measured and recorded after site instrumentation. Implants of adequate diameter (4, 4.5, or 5mm) and length (selected using preoperative CBCT) will be inserted in the prepared osteotomies to engage the bone apical to the socket insertion torque will be measured using the torque wrench and ISQ values
| Study group | Role | What they receive |
|---|---|---|
| conventional drilling group | Active comparator | Not described Receives: Procedure: conventional drilling |
| Osseodensification group | Experimental | Not described Receives: Procedure: Osseodensification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical assessment of molar septum dimensional changes of the extraction socket following osseodensification and conventional drilling protocols
Septum width will be directly measured post molar extraction. Measurement will be recorded at the narrowest width of the septum Osteotomy diameter as a reflection of septum width expansion will then be directly measured and recorded after site instrumentation
Measured: from enrollment to the day of surgery
Secondary outcomes (7)
Comparing of Residual bone volume bony Micro-architecture following osseodensification and conventional drilling protocols.
Micro-CT imaging osteotomy sites bone samples will be performed using a SkyScan 1272 microfocus X-ray system (SkyScan®, Kontich, Belgium) with software including NRecon reconstruction®, CTAn 1.8®, and CTvol. In this study, the X-ray source will be set at 70 kV and 100μA with the pixel size of 6μm, a 0.5-mm filter, and a tomographic rotation of 180° (rotation step of 0.2°). Residual bone volume (BV, μm3) around osteotomy sites will be quantified and 3-D models will be generated
Measured: Day of surgery
Comparing amount of heat generation following osseodensification and conventional drilling protocols.
Measured: from enrollment to the day of surgery
Assessment of the clinical outcomes of implant placement in the extraction socket comparing the two drilling protocols
Implant ISQ values (implant stability Quotient )
Measured: All parameters will be assessed immediately after implant placement (T0), six months (T6) and 12 months (T12)
Radiographic assessment of molar septum dimensional changes of the extraction socket following osseodensification and conventional drilling protocols
changes in vertical height and horizontal width of the septum bone
Measured: All parameters will be assessed immediately after implant placement (T0), six months (T6) and 12 months (T12)
> Volumetric assessment of the ridge buccal contour following implant placement with and without grafting the jumping gap.
comparing ridge volume changes before and after surgery with and without grafting
Measured: All parameters will be assessed preoperative, six months (T6) and 12 months (T12)
Evaluation of Patient satisfaction
Te patient satisfaction for aesthetics, function, sense, speech, and self-esteem was evaluated by a numeric rating scale ranging from 0 to 5, where 0 represents "very dissatisfed" and 5 represents "very satisfed"
Measured: day of surgery to 12 months after loading
Radiographic assessment of the vertical and horizontal dimensional changes of the alveolar ridge following implant placement comparing the 2 drilling protocols and comparing the effect of jumping gap grafting
Radiographic evaluation of vertical and horizontal alveolar bone changes will be performed on CBCT images taken immediately after implant placement (T0), six months (T6) and 12 months (T12). The following distances will be measured around the four implants surfaces; 1) P-BIC; from implant platform to the first bone contact, 2) P-T; vertical distance between implant platform and alveolar bone crest, 3) OBS; from buccal and lingual border of bone to the implant surface at the level of the implant platform (OBS0), 2 mm (OBS2), and 4 mm (OBS4) apical to implant platform.
Measured: measurements will be performed on CBCT images taken immediately after implant placement (T0), six months (T6) and 12 months (T12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2025
- Study start1 Sep 2025
- Primary completionSep 2027 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Implant OsseointegrationStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Collaborators
- Augusta University
- Responsible party
- Principal investigator, Mohammed Samir, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07108361
- Sponsor's protocol ID
- FDASU-REC ID052505
- Status last verified
- Sep 2026
- First submitted
- 8 Jul 2025
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Osseodensification Efficacy on Molar Septum Expansion in Immediate Molar Implant Placement: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07108361
- Acronym / sponsor ID
- FDASU-REC ID052505
- Conditions
- Implant Osseointegration, Implant Osteotomy, Implant Placement, Implant Primary Stability, Molar Extraction Socket, Immediate Implant Placement
- Keywords
- non restorable tooth, molar extraction, multirooted teeth, extraction socket, immediate Implant placement, Osseodensification, ex-vivo, RCT
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Collaborators
- Augusta University
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 7 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The ideal positioning of immediate implants in molar extraction sockets often requires the osteotomy to be in the interradicular septum, which can be challenging in some cases, with traditional site preparation techniques. Also, the alveolar ridge undergoes various remodeling processes following tooth extraction, resulting in hard and soft tissue loss which complicates prosthodontic rehabilitation. Immediate implant placement help preserve the alveolar ridge dimensions and buccal ridge contour. While osseodensification has shown promise in enhancing primary stability and bone microarchitecture, its clinical and microstructural effects in molar extraction sockets remain underexplored. Although there is ample documentation of information on the temperature that is generated during preparation of implant sites, there are no studies available in the literature comparing conventional drilling and osseodensification techniques; therefore, the present investigation was aimed at analyzing the efficacy of osseodensification compared to conventional drilling in terms of bone dimensions preservation , changes in bone architecture during implant site preparation and heat generation to define which technique can be safely applied to achieve the necessary implant primary stability without damaging the surrounding bone.
Aim of the study:
Is to compare the molar septum dimensions using osseodensification expansion versus the conventional drilling protocol and to assess the role of jumping gap grafting in preservation of the alveolar ridge dimensions and buccal ridge contour in addition to Evaluation of the effect of osseodensification on the bony micro-architecture and heat generation
Detailed description
The proposed study consists of two arms: 1- Clinical arm, 2- Ex-Vivo arm
The clinical arm:
80 patients with hopeless teeth requiring extraction in the molar region and requiring replacement with dental implants, will be enrolled and recruited from the outpatient clinic, faculty of dentistry, Ain shams university according to the inclusion criteria. They will be randomly allocated into two equal groups. 40 patients in the osseodensification group and 40 patients in the conventional drilling group. Each group will be further subdivided into two groups with and without jumping gap graftingPerioperative and postoperative CBCT will be ordered, and perioperative and postoperative impressions will be made and scanned for each patient to prepare a virtual 3D model before extraction and after extraction and implant placement. Molar septum dimensions will be compared before and after implant placement in addition to evaluation of vertical and horizontal alveolar bone changes and changes in bone density after placement of immediate implant in extraction socket, also a volumetric analysis will be made to assess the changes in the buccal ridge contour before and after implant placement with and without grafting of the jumping gap. Clinical outcomes will be assessed including (success and survival of implants, insertion torque, ISQ values, Probing depth, modified pink esthetic score, KTW, and patient satisfaction) all the outcomes will be assessed as baseline before the implant placement and will be followed up at 0,6 and 12 months after implant placementThe Ex-Vivo arm: study will be conducted in an ex vivo animal model using porcine bones. The animals won't be used exclusively for this study and the bones will be collected as if it was disposable as waste material, so ethical approval will not be necessary. Both tibias of a single skeletally mature porcine will be collected on the day of the slaughter. To prepare the samples, approximately 15 mm of the articular surface and subchondral bone will be removed by transversely sectioning the bones, thereby exposing the medullary portion. Three canals for thermocouples at three different depths (2 mm: T1-cortical bone, 7.5 mm: T2-cancellous bone, and 10.5 mm: T3- deep cancellous bone) from the crest of the pig bone will be drilled using 1.5 mm twist drill perpendicularly to each implant site preparation and using intermittent cutting to a distance approximately 1 mm from the planned osteotomy site.The thermocouples will be secured to the bone blocks at a distance of approximately 1 mm from the future osteotomy and insulated using sticky wax at the canal opening This study will be performed on 12 samples removed from the tibias, divided into two groups according to the drilling technique: a control group of the conventional technique (CT) (n=6), and a test group of osseodensification (OD) (n=6). The evaluation of bone microstructure using Micro-CT will follow the guidelines proposed by Bouxsein et al. (2010), which includes the use of terminologies, procedures, images, and reporting of the results. The thermocouples will be connected to a digital thermometer that allows continuous temperature reading, and temperature changes (baseline and final temperature readings) during the osteotomy preparation will be recorded for statistical analysis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional drilling group | Active comparator | Procedure: conventional drilling |
| Osseodensification group | Experimental | Procedure: Osseodensification |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients requiring placement in the posterior region.
Key exclusion criteria (5 listed)
- Pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OsseodensificationSeptum width will be directly measured post molar extraction confirming the premeasure of the CBCT. Measurement will be recorded at the narrowest width of the septum. Implant site preparation starts with a pilot drill, in clockwise motion, in the center of the septum, until 1 mm deeper than the planned implant length. Densah® Burs (Versah, LLC, Jackson, MI, USA) were then sequentially used in OD mode (counterclockwise, drilling speed 800-1500 rpm, with copious irrigation) in small increments to gradually expand the osteotomy, until reaching the desired width for the planned implant diameter, Osteotomy diameter as a reflection of septum width expansion will then be directly measured and recorded after site instrumentation. Implants of adequate diameter (4, 4.5, or 5mm) and length (selected using preoperative CBCT) will be inserted in the prepared osteotomies to engage the bone apical to the socket, insertion torque will be measured using the torque wrench and ISQ values | Procedure or surgery | Osseodensification group |
| conventional drillingSeptum width will be directly measured post molar extraction confirming the premeasure of the CBCT. Measurement will be recorded at the narrowest width of the septum. The initial (pointed) drill will be used to make a hole (starting point) in the interradicular bone to avoid slippage of the subsequent the drills in the socket of the remaining roots. The drills of increasing diameters will be used to complete the implant osteotomy according to manufacturer instructions. In case of limited interradicular bone volume, drilling will be made at the socket of mesial or distal roots. Osteotomy diameter as a reflection of septum width expansion will then be directly measured and recorded after site instrumentation. Implants of adequate diameter (4, 4.5, or 5mm) and length (selected using preoperative CBCT) will be inserted in the prepared osteotomies to engage the bone apical to the socket insertion torque will be measured using the torque wrench and ISQ values | Procedure or surgery | conventional drilling group |
Primary outcome
Clinical assessment of molar septum dimensional changes of the extraction socket following osseodensification and conventional drilling protocols
Time frame: from enrollment to the day of surgery
Septum width will be directly measured post molar extraction. Measurement will be recorded at the narrowest width of the septum Osteotomy diameter as a reflection of septum width expansion will then be directly measured and recorded after site instrumentation
7 secondary outcomes
Comparing of Residual bone volume bony Micro-architecture following osseodensification and conventional drilling protocols.
Time frame: Day of surgery
Comparing amount of heat generation following osseodensification and conventional drilling protocols.
Time frame: from enrollment to the day of surgery
Assessment of the clinical outcomes of implant placement in the extraction socket comparing the two drilling protocols
Time frame: All parameters will be assessed immediately after implant placement (T0), six months (T6) and 12 months (T12)
Radiographic assessment of molar septum dimensional changes of the extraction socket following osseodensification and conventional drilling protocols
Time frame: All parameters will be assessed immediately after implant placement (T0), six months (T6) and 12 months (T12)
> Volumetric assessment of the ridge buccal contour following implant placement with and without grafting the jumping gap.
Time frame: All parameters will be assessed preoperative, six months (T6) and 12 months (T12)
Evaluation of Patient satisfaction
Time frame: day of surgery to 12 months after loading
Radiographic assessment of the vertical and horizontal dimensional changes of the alveolar ridge following implant placement comparing the 2 drilling protocols and comparing the effect of jumping gap grafting
Time frame: measurements will be performed on CBCT images taken immediately after implant placement (T0), six months (T6) and 12 months (T12)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osseodensification and conventional drilling in people with Implant Osseointegration and Implant Osteotomy, run by Ain Shams University at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohammed Samir (01144063175, mohamedsamirramardan@dent.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical assessment of molar septum dimensional changes of the extraction socket following osseodensification and conventional drilling protocols (time frame: from enrollment to the day of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026; AzTrials last refreshed its copy on 7 Nov 2026.