IMMEDIATE IMPLANT With Different Types of Membranes

October 24, 2024 updated by: Mansoura University

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

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Mansoura, Egypt
        • Heba elsheikh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2024

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

October 23, 2024

First Submitted That Met QC Criteria

October 23, 2024

First Posted (Actual)

October 24, 2024

Study Record Updates

Last Update Posted (Actual)

October 28, 2024

Last Update Submitted That Met QC Criteria

October 24, 2024

Last Verified

October 1, 2024

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)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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