- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06657651
IMMEDIATE IMPLANT With Different Types of Membranes
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:
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 Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Mansoura, Egypt
- Heba elsheikh
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: immediate implant with dentin-derived membrane
|
immediate implant placement with dentin-derived membrane and allograft in mandibular molar area
|
|
Experimental: immediate implant with extended platelet rich fibrin membrane
|
immediate implant with extended platelet rich fibrin membrane and allograft in mandibular molar area
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
1 year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- A06030240S
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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