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
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. Contact the study team or a site near you to ask about taking part.
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.
- 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