- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07077915
- Original Trial
Osseodensification vs Conventional Drilling for Immediate Dental Implant Placement
July 23, 2025 updated by: Mohamad Ali Itani
Osseodensification vs Conventional Drilling for Immediate Dental Implant Placement: A Randomized Controlled Clinical and Radiographic Study
Aim of the study is to analyze and compare the characteristic differences occurring in the surrounding bone in an immediate implant placed by osseodensification to immediate implants placed with the conventional technique
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
Detailed Description
A bifurcation inter-radicular bone of 2 mm or more in a none restorable lower molar will be needed in order to successfully be able to drill the bone with conventional or Osseo densification burs, followed by placing the implant at this site.
A xenograft bone material will be used to fill the extraction socket and a customized temporary abutment using flowable composite and a silicone mold will be fabricated and placed over it after polishing it.
Study Type
Interventional
Enrollment (Estimated)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Beirut, Lebanon
- Beirut Arab University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patient age 25 to 45 years old
- Systemically and periodontally healthy individuals.
- Non-smokers or light smokers (Less than 5 cigarettes a day) (Schane 2010).
- Good oral hygiene.
- Healthy remaining dentition.
- Adequate quality and quantity of bone
- Interradicular septum ≥ 2 mm (Bleyan, 2022).
- Mandibular non-restorable molars.
- Type A or B socket (Smith and Tarnow, 2013).
Exclusion Criteria:
- Acute inflammation or infection in the implant region.
- Patients with mental disorders who could not cooperate with treatment or communicate normally.
- Patients who have severe systemic disorders (Uncontrolled Diabetes, Uncontrolled Hypertension, End stage kidney or liver diseases and Severe Heart diseases) .
- Poor oral hygiene.
- Active periodontal disease.
- Uncooperative patients, not willing to adhere to post-surgical instructions and follow up visits.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Osseodensification burs
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Densah burs are osseodensification burs used to condense bone and prepare dental implant site, unlike conventional technique which cuts and removes the bone
|
|
Active Comparator: Conventional Burs
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Preparation of dental implant site by the Conventional technique using Conventional burs that are subtractive
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Interradicular bone width
Time Frame: Intraoperative (at time of surgery)
|
The width of the interradicular bone in the interradicular septum will be measured immediately before and after drilling is performed during surgery.
Measurements will be taken using a UNC-15 periodontal probe and recorded in millimeters (mm).
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Intraoperative (at time of surgery)
|
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Dental implant stability
Time Frame: up to 4 months after dental implant placement
|
Implant stability will be assessed using the Osstell device, which uses resonance frequency analysis to calculate an Implant Stability Quotient (ISQ).
ISQ values range from 1 to 100, with higher values indicating greater implant stability.
|
up to 4 months after dental implant placement
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Marginal Bone Level
Time Frame: up to 7 months after the implantation
|
Bone levels will be estimated on the labial, palatal, distal, and mesial surfaces of each implant using cone-beam computed tomography (CBCT).
Measurements will be taken from a fixed reference point at the implant shoulder to the bone crest.
All measurements will be recorded in millimeters (mm).
|
up to 7 months after the implantation
|
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Bone density
Time Frame: up to 7 months after dental implant placement
|
Bone density will be measured in four regions around each dental implant: buccal, lingual, apical, and crestal.
The mean grayscale value for each implant will be calculated based on these four areas.
Bone density values will be obtained from cone-beam computed tomography (CBCT) and expressed in grayscale units.
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up to 7 months after dental implant placement
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: Nayer Aboelsaad, Phd, Beirut Arab Univeristy
- Study Director: Rania Abdelaziz, Phd, Beirut Arab University
- Study Director: Hani Arakji, Phd, Beirut Arab University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- https://omx.journals.ekb.eg/article_140845_40c7deeba68c3279a9d3dffaed37c3fd.pdf
Helpful Links
- This article includes information about the success and stability achieved by using osseodensification technique
- This article includes information regarding stability of dental implants in narrow ridges when using conventional burs and osseodensifications burs
- This study includes information about marginal bone level and dental implant stability in conventional vs osseodensification techniques
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2025
Primary Completion (Estimated)
December 23, 2025
Study Completion (Estimated)
December 23, 2025
Study Registration Dates
First Submitted
July 12, 2025
First Submitted That Met QC Criteria
July 12, 2025
First Posted (Actual)
July 22, 2025
Study Record Updates
Last Update Posted (Actual)
July 28, 2025
Last Update Submitted That Met QC Criteria
July 23, 2025
Last Verified
July 1, 2025
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2025-H-0162-D-M-0696
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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