Marginal Bone LossNCT06985511
Assessment of Marginal Bone Loss and Anterior Implant Stability in Immediate Versus Early Implant Placement
A study testing Immediate implant placement and Early implant placement in people with Marginal Bone Loss, run by Yasser Ahmed at 1 site in Lebanon.
Trial summary
This study aims to determine the differences in implant stability and measurement of bone loss near implants between two different healing approaches used for teeth replacement in the front part of the upper jaw. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Marginal Bone Loss
- What is being tested?
- Immediate implant placement and Early implant placement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteLebanon
- Study dates
- 10 Jan 2023to 15 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Presence of unrestorable bilateral anterior teeth.
- Harmonious gingival contour and thick gingival phenotype
- Minimum 4 mm of apical bone and 2 mm of intact labial plate
- Absence of periapical pathology
Who cannot join
- Systemic conditions affecting osseointegration or healing
- Active oral infections or periodontal disease
- Dehiscence or fenestration defects
- Poor oral hygiene or heavy smoking
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Marginal Bone Loss and Anterior Implant Stability in Immediate Versus Early Implant Placement: A Randomized Controlled Clinical Trial
This study aims to determine the differences in implant stability and measurement of bone loss near implants between two different healing approaches used for teeth replacement in the front part of the upper jaw.
- Conditions
- Marginal Bone Loss
- Being tested
- Immediate implant placement, Early implant placement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate implant placementProcedure or surgery
Tooth extraction was performed atraumatically on one side, followed by immediate implant placement, right after extraction.
Early implant placementProcedure or surgery
The tooth was extracted, and the implant was placed four weeks later (early placement).
| Study group | Role | What they receive |
|---|---|---|
| Immediate implant placement | Experimental | Not described Receives: Procedure: Immediate implant placement |
| Early implant placement | Active comparator | Not described Receives: Procedure: Early implant placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marginal Bone Loss
Cone beam computed tomography (CBCT) scans were obtained at the time of final restoration and post-placement. Measurements were made (in mm) from the implant platform to the most coronal bone level using OnDemand3D software. Each scan was oriented to align the implant with the axial plane. Measurements were performed by a single calibrated examiner to a precision of 0.01 mm.
Measured: up to 12 months
Implant stability
Implant Stability Quotient (ISQ) values were measured using Osstell. To ensure accuracy, the probe was positioned at a 90° angle and 3 mm above soft tissue level, as recommended in previous protocols. Osstell's patented technology uses the ISQ scale, with values ranging from 1 to 100, where higher values indicate greater stability
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2025
- Study start10 Jan 2023
- Primary completion15 Feb 2024
- Study completion15 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Marginal Bone LossStudies 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
- Crossover
- Model description
- split-mouth design
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yasser Ahmed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yasser Ahmed, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06985511
- Sponsor's protocol ID
- IRB2023-H0113D-P-0494
- Status last verified
- May 2025
- First submitted
- 15 May 2025
- Last updated
- 22 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Marginal Bone Loss and Anterior Implant Stability in Immediate Versus Early Implant Placement: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06985511
- Acronym / sponsor ID
- IRB2023-H0113D-P-0494
- Conditions
- Marginal Bone Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Yasser AhmedUniversity, hospital or other
- Study start
- 10 Jan 2023 (actual)
- Primary completion
- 15 Feb 2024 (actual)
- Study completion
- 15 Feb 2024 (actual)
- First posted
- 22 May 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.
This study aims to determine the differences in implant stability and measurement of bone loss near implants between two different healing approaches used for teeth replacement in the front part of the upper jaw.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- split-mouth design
| Arm | Type | Receives |
|---|---|---|
| Immediate implant placement | Experimental | Procedure: Immediate implant placement |
| Early implant placement | Active comparator | Procedure: Early implant placement |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Presence of unrestorable bilateral anterior teeth.
- Harmonious gingival contour and thick gingival phenotype
- Minimum 4 mm of apical bone and 2 mm of intact labial plate
- Absence of periapical pathology
Key exclusion criteria (4 listed)
- Systemic conditions affecting osseointegration or healing
- Active oral infections or periodontal disease
- Dehiscence or fenestration defects
- Poor oral hygiene or heavy smoking
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 |
|---|---|---|
| Immediate implant placementTooth extraction was performed atraumatically on one side, followed by immediate implant placement, right after extraction. | Procedure or surgery | Immediate implant placement |
| Early implant placementThe tooth was extracted, and the implant was placed four weeks later (early placement). | Procedure or surgery | Early implant placement |
Primary outcome
Marginal Bone Loss
Time frame: up to 12 months
Cone beam computed tomography (CBCT) scans were obtained at the time of final restoration and post-placement. Measurements were made (in mm) from the implant platform to the most coronal bone level using OnDemand3D software. Each scan was oriented to align the implant with the axial plane. Measurements were performed by a single calibrated examiner to a precision of 0.01 mm.
Implant stability
Time frame: up to 12 months
Implant Stability Quotient (ISQ) values were measured using Osstell. To ensure accuracy, the probe was positioned at a 90° angle and 3 mm above soft tissue level, as recommended in previous protocols. Osstell's patented technology uses the ISQ scale, with values ranging from 1 to 100, where higher values indicate greater stability
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
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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. This study is not recruiting at the moment.
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 Immediate implant placement and Early implant placement in people with Marginal Bone Loss, run by Yasser Ahmed 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 22 May 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Marginal Bone Loss (time frame: up to 12 months). 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?
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 May 2025.