Immediate Dental Implant PlacementNCT07077915
Osseodensification vs Conventional Drilling for Immediate Dental Implant Placement
A study testing Osseodensification burs and Conventional burs in people with Immediate Dental Implant Placement and Conventional Drilling Technique, run by Mohamad Ali Itani at 1 site in Lebanon.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 25 to 45 years
- Conditions the study is for
- Immediate Dental Implant Placement, Conventional Drilling Technique, Osseodensification Drilling Technique
- What is being tested?
- Osseodensification burs and Conventional burs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteLebanon
- Study dates
- 1 Jul 2025to 23 Dec 2025
- 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 25 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Show all 9Show fewer
- Interradicular septum ≥ 2 mm (Bleyan, 2022).
- Mandibular non-restorable molars.
- Type A or B socket (Smith and Tarnow, 2013).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
Read the 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.
- Conditions
- Immediate Dental Implant Placement, Conventional Drilling Technique, Osseodensification Drilling Technique
- Being tested
- Osseodensification burs, Conventional burs
- Keywords
- immediate dental implant, immediate dental implant with bone graft, osseodensification, conventional drilling, densah burs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osseodensification bursOther
Densah burs are osseodensification burs used to condense bone and prepare dental implant site, unlike conventional technique which cuts and removes the bone
Conventional bursOther
Preparation of dental implant site by the Conventional technique using Conventional burs that are subtractive
| Study group | Role | What they receive |
|---|---|---|
| Osseodensification burs | Experimental | Not described Receives: Other: Osseodensification burs |
| Conventional Burs | Active comparator | Not described Receives: Other: Conventional burs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interradicular bone width
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).
Measured: Intraoperative (at time of surgery)
Dental implant stability
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.
Measured: up to 4 months after dental implant placement
Secondary outcomes (2)
Marginal Bone Level
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).
Measured: up to 7 months after the implantation
Bone density
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.
Measured: up to 7 months after dental 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 2025
- Study start1 Jul 2025
- Primary completion23 Dec 2025 (estimated)
- Study completion23 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mohamad Ali Itani
- Sponsor type
- University, hospital or other
- Collaborators
- Beirut Arab University
- Responsible party
- Sponsor-investigator, Mohamad Ali Itani, Beirut Arab University
- Investigators
- Nayer Aboelsaad, Phd, Study chair, Beirut Arab UniveristyRania Abdelaziz, Phd, Study director, Beirut Arab UniversityHani Arakji, Phd, Study director, Beirut Arab University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07077915
- Sponsor's protocol ID
- 2025-H-0162-D-M-0696
- Status last verified
- Jul 2025
- First submitted
- 12 Jul 2025
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
https://omx.journals.ekb.eg/article_140845_40c7deeba68c3279a9d3dffaed37c3fd.pdf
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osseodensification vs Conventional Drilling for Immediate Dental Implant Placement: A Randomized Controlled Clinical and Radiographic Study
- ClinicalTrials.gov ID
- NCT07077915
- Acronym / sponsor ID
- 2025-H-0162-D-M-0696
- Conditions
- Immediate Dental Implant Placement, Conventional Drilling Technique, Osseodensification Drilling Technique
- Keywords
- immediate dental implant, immediate dental implant with bone graft, osseodensification, conventional drilling, densah burs
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Mohamad Ali ItaniUniversity, hospital or other
- Collaborators
- Beirut Arab University
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 23 Dec 2025 (estimated)
- Study completion
- 23 Dec 2025 (estimated)
- First posted
- 22 Jul 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.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Osseodensification burs | Experimental | Other: Osseodensification burs |
| Conventional Burs | Active comparator | Other: Conventional burs |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
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 bursDensah burs are osseodensification burs used to condense bone and prepare dental implant site, unlike conventional technique which cuts and removes the bone | Other | Osseodensification burs |
| Conventional bursPreparation of dental implant site by the Conventional technique using Conventional burs that are subtractive | Other | Conventional Burs |
Primary outcome
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).
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.
2 secondary outcomes
Marginal Bone Level
Time frame: up to 7 months after the implantation
Bone density
Time frame: up to 7 months after dental 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 28 Jul 2025.
- Backgroundhttps://omx.journals.ekb.eg/article_140845_40c7deeba68c3279a9d3dffaed37c3fd.pdf
- This article includes information about the success and stability achieved by using osseodensification techniqueLink provided by the sponsor.
- This article includes information regarding stability of dental implants in narrow ridges when using conventional burs and osseodensifications bursLink provided by the sponsor.
- This study includes information about marginal bone level and dental implant stability in conventional vs osseodensification techniquesLink provided by the sponsor.
- 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.
Nayer Aboelsaad, Phd study chair
Beirut Arab Univeristy
Rania Abdelaziz, Phd study director
Beirut Arab University
Hani Arakji, Phd study director
Beirut Arab University
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 burs and Conventional burs in people with Immediate Dental Implant Placement and Conventional Drilling Technique, run by Mohamad Ali Itani at 1 site in Lebanon.
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 9 inclusion and 6 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 28 Jul 2025. 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 Lebanon. 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?
Interradicular bone width (time frame: Intraoperative (at time of surgery)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07077915, which also lists 1 linked publication.
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 28 Jul 2025.