Immediate Dental Implant PlacementNCT07719764
Implant Stability Outcomes Following Immediate Implant Placement Using Osseodensification Versus Conventional Drilling
A study testing Osseodensification drilling and Conventional drilling in people with Immediate Dental Implant Placement and Lower Molar Requiring Extraction, run by Dar Al Uloom University at 1 site in Saudi Arabia.
Trial summary
The goal of this randomized clinical trial is to compare osseodensification and conventional drilling for immediate dental implant placement in mandibular molar extraction sockets in adults requiring extraction and implant replacement. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Immediate Dental Implant Placement, Lower Molar Requiring Extraction
- What is being tested?
- Osseodensification drilling and Conventional drilling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 20 Dec 2025to 30 Sep 2026
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults aged 20 years - 50 years. Patients requiring extraction of a mandibular first or second molar with immediate implant placement.
- Presence of sufficient interradicular and apical bone to achieve primary implant stability following immediate implant placement.
- Adequate bone dimensions to accommodate the planned dental implant without the need for extensive bone augmentation.
- Good oral hygiene and willingness to comply with the study protocol and follow-up visits.
- Ability to understand the study procedures and provide written informed consent.
- -
Who cannot join
- Uncontrolled systemic diseases or medical conditions contraindicating oral surgery or implant placement.
- Pregnancy or lactation. Current smokers or tobacco users. Untreated active periodontal disease or poor oral hygiene. Acute infection or extensive pathology at the implant site that would preclude immediate implant placement.
- History of radiotherapy to the head and neck region or treatment with intravenous bisphosphonates or other medications known to adversely affect bone healing.
- Bruxism or parafunctional habits likely to compromise implant success. Inability or unwillingness to attend scheduled follow-up visits or comply with study requirements.
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Saudi Arabia1 site
Dar AlUloom University, College of Dentistry
Riyadh, 11512
About this study
Official title: Clinical, Radiographic, and Implant Stability Outcomes Following Immediate Implant Placement Using Osseodensification Versus Conventional Drilling in Mandibular Molar Extraction Sockets: A Randomized Clinical Trial
The goal of this randomized clinical trial is to compare osseodensification and conventional drilling for immediate dental implant placement in mandibular molar extraction sockets in adults requiring extraction and implant replacement.
The main questions it aims to answer are:
Read more
Does osseodensification improve primary and secondary implant stability compared with conventional drilling? Does osseodensification result in better clinical and radiographic peri-implant outcomes, including marginal bone loss, peri-implant bone density, probing depth, plaque and bleeding indices, during the healing period?
Researchers will compare immediate implant placement performed using osseodensification drilling with immediate implant placement performed using conventional drilling to determine whether osseodensification provides superior implant stability and peri-implant tissue outcomes.
Participants will:
Undergo atraumatic extraction of a mandibular molar followed by immediate implant placement.
Be randomly assigned to receive implant site preparation using either osseodensification or conventional drilling.
Receive the same implant system and standardized surgical and prosthetic protocols.
Attend scheduled follow-up visits for clinical examinations, implant stability measurements using resonance frequency analysis (ISQ), and radiographic evaluation of marginal bone loss and peri-implant bone density during healing and after prosthetic restoration.
Read the detailed description
Immediate implant placement into fresh extraction sockets has become a well-established treatment approach because it reduces treatment time, decreases the number of surgical procedures, and helps preserve hard and soft tissue architecture. Nevertheless, obtaining adequate primary implant stability in fresh mandibular molar extraction sockets remains a major clinical challenge because of socket morphology, limited interradicular bone, and variations in bone density.
Osseodensification is a non-subtractive osteotomy preparation technique that uses specially designed burs rotating in a densifying mode to preserve and compact bone around the implant osteotomy. Unlike conventional drilling, which removes bone during osteotomy preparation, osseodensification compacts autogenous bone along the osteotomy walls, potentially increasing bone density, bone-to-implant contact, and primary implant stability while promoting favorable healing.
Although promising results have been reported for osseodensification, clinical evidence directly comparing this technique with conventional drilling during immediate implant placement in mandibular molar extraction sockets remains limited. This randomized clinical trial was designed to evaluate whether osseodensification provides superior clinical, radiographic, and implant stability outcomes compared with conventional drilling.
Eligible participants requiring extraction of a mandibular molar followed by immediate implant placement were randomly allocated to one of two treatment groups:
Osseodensification group: implant osteotomy prepared using the osseodensification drilling protocol.
Conventional drilling group: implant osteotomy prepared using the manufacturer's conventional drilling sequence.
All participants underwent atraumatic tooth extraction, immediate implant placement using the same implant system, grafting of the peri-implant gap when indicated according to the study protocol, customized healing abutment placement, and standardized prosthetic rehabilitation after the healing period. Postoperative care and follow-up schedules were standardized for both groups.
Clinical evaluations included assessment of the modified plaque index, modified bleeding index, and peri-implant probing depth. Implant stability was assessed using resonance frequency analysis and expressed as the Implant Stability Quotient (ISQ). Radiographic assessments included measurements of marginal bone loss using standardized periapical radiographs and peri-implant bone density using cone-beam computed tomography (CBCT). Participants were followed according to the study schedule to evaluate implant stability, peri-implant tissue health, and radiographic bone changes during healing and after functional restoration.
The primary objective of the trial was to compare primary and secondary implant stability between osseodensification and conventional drilling. Secondary objectives included comparison of peri-implant clinical parameters, marginal bone loss, and peri-implant bone density between the two treatment groups.
- Being tested
- Osseodensification drilling, Conventional drilling
- Keywords
- Immediate implant, osseodensification, lower molar, implant stability, conventional drilling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osseodensification drillingProcedure or surgery
Implant osteotomy preparation was performed using the osseodensification drilling protocol with densifying burs rotating in densifying mode before immediate implant placement in mandibular molar extraction sockets.
Conventional drillingProcedure or surgery
Implant osteotomy preparation was performed using the conventional sequential drilling protocol before immediate implant placement in mandibular molar extraction
| Study group | Role | What they receive |
|---|---|---|
| osseodensification drilling group | Experimental | Immediate implant placement using osseodensification drilling for implant osteotomy preparation. Receives: Procedure: Osseodensification drilling |
| conventional drilling protocol | Active comparator | Immediate implant placement using the conventional drilling protocol for implant osteotomy preparation. Receives: Procedure: Conventional drilling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Implant Stability
Implant stability, measured by the Implant Stability Quotient (ISQ) using resonance frequency analysis (RFA), assessed immediately after implant placement (primary stability) and during the follow-up period (at 3 months) to evaluate secondary stability.
Implant stability will be assessed using resonance frequency analysis (RFA) with the Osstell® device. Stability will be expressed as the Implant Stability Quotient (ISQ), a unitless index ranging from 1 to 100, where higher ISQ values indicate greater implant stability. Measurements will be obtained by attaching a SmartPeg to the implant and recording ISQ values in two perpendicular directions (buccolingual and mesiodistal). The mean of the two measurements will be used for statistical analysis. Implant stability will be evaluated immediately after implant placement (baseline/primary stability), and at 3 months and 6 months postoperatively (secondary stability). The primary outcome will be the difference in mean ISQ values between the
Measured: Day 0, and 3 months
Secondary outcomes (6)
Secondary Implant Stability
Secondary implant stability assessed using resonance frequency analysis (RFA) and expressed as the Implant Stability Quotient (ISQ).
Measured: 3 months after implant placement
Marginal Bone Loss (MBL)
Marginal bone loss measured on standardized digital periapical radiographs as the distance from the implant reference point to the first bone-to-implant contact on the mesial and distal aspects.
Measured: Baseline, 3 months, and 6 months after implant placement
Peri-implant Bone Density
Bone density surrounding the implant measured using cone-beam computed tomography (CBCT) and expressed in Hounsfield Units (HU).
Measured: Baseline, 3 months, and 6 months after implant placement
Peri-implant Probing Depth (PPD)
Peri-implant probing depth measured in millimeters at four sites around each implant using a periodontal probe.
Measured: 3 months and 6 months after implant placement
Modified Plaque Index (mPI)
Plaque accumulation around implants assessed using the Modified Plaque Index.
Measured: Baseline, 3 months, and 6 months after implant placement
Modified Bleeding Index (mBI)
Peri-implant soft tissue inflammation assessed using the Modified Bleeding Index.
Measured: Baseline, 3 months, and 6 months after implant placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study start20 Dec 2025
- Primary completion15 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immediate Dental Implant PlacementStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dar Al Uloom University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sally Abd-ElMeniem ElHaddad, Dar Al Uloom University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07719764
- Sponsor's protocol ID
- # 37-03-2025
- Status last verified
- Jul 2026
- First submitted
- 7 Jul 2026
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to institutional and ethical restrictions regarding participant confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical, Radiographic, and Implant Stability Outcomes Following Immediate Implant Placement Using Osseodensification Versus Conventional Drilling in Mandibular Molar Extraction Sockets: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07719764
- Acronym / sponsor ID
- # 37-03-2025
- Keywords
- Immediate implant, osseodensification, lower molar, implant stability, conventional drilling
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Dar Al Uloom UniversityUniversity, hospital or other
- Study start
- 20 Dec 2025 (actual)
- Primary completion
- 15 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 22 Jul 2026 (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 goal of this randomized clinical trial is to compare osseodensification and conventional drilling for immediate dental implant placement in mandibular molar extraction sockets in adults requiring extraction and implant replacement.
The main questions it aims to answer are:
Does osseodensification improve primary and secondary implant stability compared with conventional drilling? Does osseodensification result in better clinical and radiographic peri-implant outcomes, including marginal bone loss, peri-implant bone density, probing depth, plaque and bleeding indices, during the healing period?
Researchers will compare immediate implant placement performed using osseodensification drilling with immediate implant placement performed using conventional drilling to determine whether osseodensification provides superior implant stability and peri-implant tissue outcomes.
Participants will:
Undergo atraumatic extraction of a mandibular molar followed by immediate implant placement.
Be randomly assigned to receive implant site preparation using either osseodensification or conventional drilling.
Receive the same implant system and standardized surgical and prosthetic protocols.
Attend scheduled follow-up visits for clinical examinations, implant stability measurements using resonance frequency analysis (ISQ), and radiographic evaluation of marginal bone loss and peri-implant bone density during healing and after prosthetic restoration.
Detailed description
Immediate implant placement into fresh extraction sockets has become a well-established treatment approach because it reduces treatment time, decreases the number of surgical procedures, and helps preserve hard and soft tissue architecture. Nevertheless, obtaining adequate primary implant stability in fresh mandibular molar extraction sockets remains a major clinical challenge because of socket morphology, limited interradicular bone, and variations in bone density.
Osseodensification is a non-subtractive osteotomy preparation technique that uses specially designed burs rotating in a densifying mode to preserve and compact bone around the implant osteotomy. Unlike conventional drilling, which removes bone during osteotomy preparation, osseodensification compacts autogenous bone along the osteotomy walls, potentially increasing bone density, bone-to-implant contact, and primary implant stability while promoting favorable healing.
Although promising results have been reported for osseodensification, clinical evidence directly comparing this technique with conventional drilling during immediate implant placement in mandibular molar extraction sockets remains limited. This randomized clinical trial was designed to evaluate whether osseodensification provides superior clinical, radiographic, and implant stability outcomes compared with conventional drilling.
Eligible participants requiring extraction of a mandibular molar followed by immediate implant placement were randomly allocated to one of two treatment groups:
Osseodensification group: implant osteotomy prepared using the osseodensification drilling protocol.
Conventional drilling group: implant osteotomy prepared using the manufacturer's conventional drilling sequence.
All participants underwent atraumatic tooth extraction, immediate implant placement using the same implant system, grafting of the peri-implant gap when indicated according to the study protocol, customized healing abutment placement, and standardized prosthetic rehabilitation after the healing period. Postoperative care and follow-up schedules were standardized for both groups.
Clinical evaluations included assessment of the modified plaque index, modified bleeding index, and peri-implant probing depth. Implant stability was assessed using resonance frequency analysis and expressed as the Implant Stability Quotient (ISQ). Radiographic assessments included measurements of marginal bone loss using standardized periapical radiographs and peri-implant bone density using cone-beam computed tomography (CBCT). Participants were followed according to the study schedule to evaluate implant stability, peri-implant tissue health, and radiographic bone changes during healing and after functional restoration.
The primary objective of the trial was to compare primary and secondary implant stability between osseodensification and conventional drilling. Secondary objectives included comparison of peri-implant clinical parameters, marginal bone loss, and peri-implant bone density between the two treatment groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| osseodensification drilling group | Experimental | Procedure: Osseodensification drillingImmediate implant placement using osseodensification drilling for implant osteotomy preparation. |
| conventional drilling protocol | Active comparator | Procedure: Conventional drillingImmediate implant placement using the conventional drilling protocol for implant osteotomy preparation. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Adults aged 20 years - 50 years. Patients requiring extraction of a mandibular first or second molar with immediate implant placement.
- Presence of sufficient interradicular and apical bone to achieve primary implant stability following immediate implant placement.
- Adequate bone dimensions to accommodate the planned dental implant without the need for extensive bone augmentation.
- Good oral hygiene and willingness to comply with the study protocol and follow-up visits.
- Ability to understand the study procedures and provide written informed consent.
Key exclusion criteria (5 listed)
- Uncontrolled systemic diseases or medical conditions contraindicating oral surgery or implant placement.
- Pregnancy or lactation. Current smokers or tobacco users. Untreated active periodontal disease or poor oral hygiene. Acute infection or extensive pathology at the implant site that would preclude immediate implant placement.
- History of radiotherapy to the head and neck region or treatment with intravenous bisphosphonates or other medications known to adversely affect bone healing.
- Bruxism or parafunctional habits likely to compromise implant success. Inability or unwillingness to attend scheduled follow-up visits or comply with study requirements.
- -
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 |
|---|---|---|
| Osseodensification drillingImplant osteotomy preparation was performed using the osseodensification drilling protocol with densifying burs rotating in densifying mode before immediate implant placement in mandibular molar extraction sockets. | Procedure or surgery | osseodensification drilling group |
| Conventional drillingImplant osteotomy preparation was performed using the conventional sequential drilling protocol before immediate implant placement in mandibular molar extraction | Procedure or surgery | conventional drilling protocol |
Primary outcome
Primary Implant Stability
Time frame: Day 0, and 3 months
Implant stability, measured by the Implant Stability Quotient (ISQ) using resonance frequency analysis (RFA), assessed immediately after implant placement (primary stability) and during the follow-up period (at 3 months) to evaluate secondary stability. Implant stability will be assessed using resonance frequency analysis (RFA) with the Osstell® device. Stability will be expressed as the Implant Stability Quotient (ISQ), a unitless index ranging from 1 to 100, where higher ISQ values indicate greater implant stability. Measurements will be obtained by attaching a SmartPeg to the implant and recording ISQ values in two perpendicular directions (buccolingual and mesiodistal). The mean of the two measurements will be used for statistical analysis. Implant stability will be evaluated immediately after implant placement (baseline/primary stability), and at 3 months and 6 months postoperatively (secondary stability). The primary outcome will be the difference in mean ISQ values between the
6 secondary outcomes
Secondary Implant Stability
Time frame: 3 months after implant placement
Marginal Bone Loss (MBL)
Time frame: Baseline, 3 months, and 6 months after implant placement
Peri-implant Bone Density
Time frame: Baseline, 3 months, and 6 months after implant placement
Peri-implant Probing Depth (PPD)
Time frame: 3 months and 6 months after implant placement
Modified Plaque Index (mPI)
Time frame: Baseline, 3 months, and 6 months after implant placement
Modified Bleeding Index (mBI)
Time frame: Baseline, 3 months, and 6 months after implant placement
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 22 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to institutional and ethical restrictions regarding participant confidentiality.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osseodensification drilling and Conventional drilling in people with Immediate Dental Implant Placement and Lower Molar Requiring Extraction, run by Dar Al Uloom University at 1 site in Saudi Arabia.
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: enrolling by invitation, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Implant Stability (time frame: Day 0, and 3 months). 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 22 Jul 2026.