Tooth ExtractionNCT06657651
IMMEDIATE IMPLANT With Different Types of Membranes
A study testing immediate implant placement with dentin-derived membrane and immediate implant with extended platelet rich fibrin membrane in people with Tooth Extraction, run by Mansoura University at 1 site in Egypt.
Trial summary
forty patients will be selected from the outpatient's clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Mansoura University for replacement of non-restorable tooth in posterior mandibular area. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Extraction
- What is being tested?
- immediate implant placement with dentin-derived membrane and immediate implant with extended platelet rich fibrin membrane
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Jun 2024to 1 Jun 2025
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age above 18 years
- Non-restorable mandibular molar tooth that needs dental extraction \& guided bone regeneration for immediate implant placement.
- Acceptable inter-arch space for the future prosthesis.
- Patient medically free from systemic diseases that absolutely contraindicate implant surgery.
- Cooperative patient with high motivation and acceptable oral hygiene.
- Free from history of bruxism / parafunctional habits.
Who cannot join
- Local and / or systemic conditions that interfere with the procedure.
- Smokers.
- Pregnancy.
- Uncooperative patients.
- Patient had undergone in the past 12 months radiation therapy to the head and neck area.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Autogenous Dentine Derived Barrier Membrane Versus Extended Platelet Rich Fibrin Membrane in Immediate Implant Placement
forty patients will be selected from the outpatient's clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Mansoura University for replacement of non-restorable tooth in posterior mandibular area.
Patients' Grouping:
Read more
The patients will be randomly divided into two equal uniform groups each consists of 20 patients:
Group A:
20 patients with non-restorable mandibular molar tooth will be treated with an immediately placed dental implant in conjunction with a dentin-derived membrane from the extracted tooth.
Group B:
20 patients with non-restorable mandibular molar tooth will be treated with an immediately placed dental implant in conjunction with extended platelet rich fibrin membrane.
- Conditions
- Tooth Extraction
- Being tested
- immediate implant placement with dentin-derived membrane, immediate implant with extended platelet rich fibrin membrane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immediate implant placement with dentin-derived membraneProcedure or surgery
immediate implant placement with dentin-derived membrane and allograft in mandibular molar area
immediate implant with extended platelet rich fibrin membraneProcedure or surgery
immediate implant with extended platelet rich fibrin membrane and allograft in mandibular molar area
| Study group | Role | What they receive |
|---|---|---|
| immediate implant with dentin-derived membrane | Experimental | Not described Receives: Procedure: immediate implant placement with dentin-derived membrane |
| immediate implant with extended platelet rich fibrin membrane | Experimental | Not described Receives: Procedure: immediate implant with extended platelet rich fibrin membrane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant stability
Osstell will be used to record implant stability at the placement time, 3, 6 and 12 months after surgery.
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 posted24 Oct 2024
- Study start30 Jun 2024
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth ExtractionStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06657651
- Sponsor's protocol ID
- A06030240S
- Status last verified
- Oct 2024
- First submitted
- 23 Oct 2024
- Last updated
- 28 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autogenous Dentine Derived Barrier Membrane Versus Extended Platelet Rich Fibrin Membrane in Immediate Implant Placement
- ClinicalTrials.gov ID
- NCT06657651
- Acronym / sponsor ID
- A06030240S
- Conditions
- Tooth Extraction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 30 Jun 2024 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 24 Oct 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.
forty patients will be selected from the outpatient's clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Mansoura University for replacement of non-restorable tooth in posterior mandibular area.
Patients' Grouping:
The patients will be randomly divided into two equal uniform groups each consists of 20 patients:
Group A:
20 patients with non-restorable mandibular molar tooth will be treated with an immediately placed dental implant in conjunction with a dentin-derived membrane from the extracted tooth.
Group B:
20 patients with non-restorable mandibular molar tooth will be treated with an immediately placed dental implant in conjunction with extended platelet rich fibrin membrane.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| immediate implant with dentin-derived membrane | Experimental | Procedure: immediate implant placement with dentin-derived membrane |
| immediate implant with extended platelet rich fibrin membrane | Experimental | Procedure: immediate implant with extended platelet rich fibrin membrane |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age above 18 years
- Non-restorable mandibular molar tooth that needs dental extraction \& guided bone regeneration for immediate implant placement.
- Acceptable inter-arch space for the future prosthesis.
- Patient medically free from systemic diseases that absolutely contraindicate implant surgery.
- Cooperative patient with high motivation and acceptable oral hygiene.
Key exclusion criteria (5 listed)
- Local and / or systemic conditions that interfere with the procedure.
- Smokers.
- Pregnancy.
- Uncooperative patients.
- Patient had undergone in the past 12 months radiation therapy to the head and neck area.
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 placement with dentin-derived membraneimmediate implant placement with dentin-derived membrane and allograft in mandibular molar area | Procedure or surgery | immediate implant with dentin-derived membrane |
| immediate implant with extended platelet rich fibrin membraneimmediate implant with extended platelet rich fibrin membrane and allograft in mandibular molar area | Procedure or surgery | immediate implant with extended platelet rich fibrin membrane |
Primary outcome
Implant stability
Time frame: 1 year
Osstell will be used to record implant stability at the placement time, 3, 6 and 12 months after surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2024.
- 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. 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 with dentin-derived membrane and immediate implant with extended platelet rich fibrin membrane in people with Tooth Extraction, run by Mansoura University at 1 site 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 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: status not confirmed, as of the sponsor's last update on 28 Oct 2024. 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 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?
Implant stability (time frame: 1 year). 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 28 Oct 2024.