TOOTH EXTRACTIONDDBM dentalNCT06615362
Autogenous Dentin Derived Barrier Membrane Versus Collagen Membrane
A study testing preparation of dentin membrane from hopeless tooth for Guided Bone Regeneration in Immediate Implant and Collagen Membrane for Guided Bone Regeneration in Immediate Implant in people with TOOTH EXTRACTION and IMMEDIATE IMPLANT, run by Mansoura University at 2 sites in Egypt.
Trial summary
Autogenous Dentin Derived Barrier Membrane versus Collagen Membrane Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- TOOTH EXTRACTION, IMMEDIATE IMPLANT
- What is being tested?
- preparation of dentin membrane from hopeless tooth for Guided Bone Regeneration in Immediate Implant and Collagen Membrane for Guided Bone Regeneration in Immediate Implant
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesEgypt
- Study dates
- 10 Apr 2022to 10 Oct 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patient's age ranges from 18-50 years.
- Adequate inter-arch relation and inter-occlusal space that could accommodate the implant abutment and the future restoration
- Non-restorable tooth that needs dental extraction \& guided bone regeneration for immediate implant.
- Presence of alveolar bone defect with vertical loss of buccal bone more than a third implant thread.
- Co-operative patients willing to complete the follow-up periods.
Who cannot join
- Any pathological condition at site of surgery.
- Patients with systemic diseases that contra-indicate the surgical procedure.
- Heavy smoking.
- Parafunctional habits such as bruxism and clenching.
- Pregnant patients. -
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Mansoura University, faculty of dentistry ,Department of Oral and Maxillofacial
Al Mansurah, Eygpt, 002
Elhussein Farag
Al Mansurah, Eygpt
About this study
Official title: Autogenous Dentin Derived Barrier Membrane Versus Collagen Membrane for Guided Bone Regeneration in Immediate Implant
Autogenous Dentin Derived Barrier Membrane versus Collagen Membrane
Read the detailed description
Autogenous Dentin Derived Barrier Membrane versus Collagen Membrane for Guided Bone Regeneration in Immediate Implant
- Conditions
- TOOTH EXTRACTION, IMMEDIATE IMPLANT
- Being tested
- preparation of dentin membrane from hopeless tooth for Guided Bone Regeneration in Immediate Implant, Collagen Membrane for Guided Bone Regeneration in Immediate Implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
preparation of dentin membrane from hopeless tooth for Guided Bone Regeneration in Immediate ImplantProcedure or surgery
tooth extraction , preparation of dentin membrane ,immediate implantation ,Xenogeneic bone graft material, application of dentin derived barrier membrane
Collagen Membrane for Guided Bone Regeneration in Immediate ImplantProcedure or surgery
like group one but with application of collagen membrane
| Study group | Role | What they receive |
|---|---|---|
| Autogenous Dentin Derived Barrier Membrane | Experimental | Autogenous Dentin Derived Barrier Membrane + Xenogeneic bone graft material+ immediate implant Receives: Procedure: preparation of dentin membrane from hopeless tooth for Guided Bone Regeneration in Immediate Implant |
| Collagen Membrane | Experimental | Collagen Membrane + Xenogeneic bone graft material + immediate implant Receives: Procedure: Collagen Membrane for Guided Bone Regeneration in Immediate Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
All patients were evaluated radiographically immediately postoperative,and after 12 months
Radiographic Evaluation Cone Beam Computed Tomography scan was taken to measure Marginal Bone loss and Relative bone density
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study start10 Apr 2022
- Primary completion10 Apr 2024
- Study completion10 Oct 2024 (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 TOOTH EXTRACTIONStudies 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
- Model description
- Two arms: one arm Autogenous Dentin Derived Barrier Membrane ,second arm Collagen Membrane .
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Heba Elsheikh Assistant professor, Assistant professor, Study chair, Mansoura University, faculty of dentistry ,Department of Oral and Maxillofacial
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06615362
- Sponsor's protocol ID
- A04010222
- Acronym
- DDBM dental
- Status last verified
- Sep 2024
- First submitted
- 7 Sep 2024
- Last updated
- 26 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mohamad EHFA, Awad S, Abbas MH, Elsheikh HA. Autogenous dentin-derived membrane as a biologic alternative to collagen membrane for guided bone regeneration in immediate implant placement in the posterior mandible: a randomized clinical trial. Odontology. 2025 Dec 10. doi: 10.1007/s10266-025-01271-6. Online ahead of print.
PubMed 41372516
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autogenous Dentin Derived Barrier Membrane Versus Collagen Membrane for Guided Bone Regeneration in Immediate Implant
- ClinicalTrials.gov ID
- NCT06615362
- Acronym / sponsor ID
- DDBM dental / A04010222
- Conditions
- TOOTH EXTRACTION, IMMEDIATE IMPLANT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 10 Apr 2022 (actual)
- Primary completion
- 10 Apr 2024 (actual)
- Study completion
- 10 Oct 2024 (estimated)
- First posted
- 26 Sep 2024 (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.
Autogenous Dentin Derived Barrier Membrane versus Collagen Membrane
Detailed description
Autogenous Dentin Derived Barrier Membrane versus Collagen Membrane for Guided Bone Regeneration in Immediate Implant
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two arms: one arm Autogenous Dentin Derived Barrier Membrane ,second arm Collagen Membrane .
| Arm | Type | Receives |
|---|---|---|
| Autogenous Dentin Derived Barrier Membrane | Experimental | Procedure: preparation of dentin membrane from hopeless tooth for Guided Bone Regeneration in Immediate ImplantAutogenous Dentin Derived Barrier Membrane + Xenogeneic bone graft material+ immediate implant |
| Collagen Membrane | Experimental | Procedure: Collagen Membrane for Guided Bone Regeneration in Immediate ImplantCollagen Membrane + Xenogeneic bone graft material + immediate implant |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patient's age ranges from 18-50 years.
- Adequate inter-arch relation and inter-occlusal space that could accommodate the implant abutment and the future restoration
- Non-restorable tooth that needs dental extraction \& guided bone regeneration for immediate implant.
- Presence of alveolar bone defect with vertical loss of buccal bone more than a third implant thread.
- Co-operative patients willing to complete the follow-up periods.
Key exclusion criteria (5 listed)
- Any pathological condition at site of surgery.
- Patients with systemic diseases that contra-indicate the surgical procedure.
- Heavy smoking.
- Parafunctional habits such as bruxism and clenching.
- Pregnant patients. -
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 |
|---|---|---|
| preparation of dentin membrane from hopeless tooth for Guided Bone Regeneration in Immediate Implanttooth extraction , preparation of dentin membrane ,immediate implantation ,Xenogeneic bone graft material, application of dentin derived barrier membrane | Procedure or surgery | Autogenous Dentin Derived Barrier Membrane |
| Collagen Membrane for Guided Bone Regeneration in Immediate Implantlike group one but with application of collagen membrane | Procedure or surgery | Collagen Membrane |
Primary outcome
All patients were evaluated radiographically immediately postoperative,and after 12 months
Time frame: 1 year
Radiographic Evaluation Cone Beam Computed Tomography scan was taken to measure Marginal Bone loss and Relative bone density
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2024.
- Derived from this study: PubMed 41372516Mohamad EHFA, Awad S, Abbas MH, Elsheikh HA. Autogenous dentin-derived membrane as a biologic alternative to collagen membrane for guided bone regeneration in immediate implant placement in the posterior mandible: a randomized clinical trial. Odontology. 2025 Dec 10. doi: 10.1007/s10266-025-01271-6. Online ahead of print.
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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.
Heba Elsheikh Assistant professor, Assistant professor study chair
Mansoura University, faculty of dentistry ,Department of Oral and Maxillofacial
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing preparation of dentin membrane from hopeless tooth for Guided Bone Regeneration in Immediate Implant and Collagen Membrane for Guided Bone Regeneration in Immediate Implant in people with TOOTH EXTRACTION and IMMEDIATE IMPLANT, run by Mansoura 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 5 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: status not confirmed, as of the sponsor's last update on 26 Sep 2024. 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?
Results are not available in the source record.
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?
All patients were evaluated radiographically immediately postoperative,and after 12 months (time frame: 1 year). 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 NCT06615362, 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 26 Sep 2024.