Autogenous Dentin Derived Barrier Membrane Versus Collagen Membrane (DDBM dental)

September 24, 2024 updated by: Mansoura University

Autogenous Dentin Derived Barrier Membrane Versus Collagen Membrane for Guided Bone Regeneration in Immediate Implant

Autogenous Dentin Derived Barrier Membrane versus Collagen Membrane

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Autogenous Dentin Derived Barrier Membrane versus Collagen Membrane for Guided Bone Regeneration in Immediate Implant

Study Type

Interventional

Enrollment (Actual)

20

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

  • Egypt
    • Eygpt
      • Mansoura, Eygpt, Egypt, 002
        • Mansoura University, faculty of dentistry ,Department of Oral and Maxillofacial
      • Mansoura, Eygpt, Egypt
        • Elhussein Farag

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:

  1. Patient's age ranges from 18-50 years.
  2. Adequate inter-arch relation and inter-occlusal space that could accommodate the implant abutment and the future restoration
  3. Non-restorable tooth that needs dental extraction & guided bone regeneration for immediate implant.
  4. Presence of alveolar bone defect with vertical loss of buccal bone more than a third implant thread.
  5. Co-operative patients willing to complete the follow-up periods.

Exclusion Criteria:

  1. Any pathological condition at site of surgery.
  2. Patients with systemic diseases that contra-indicate the surgical procedure.
  3. Heavy smoking.
  4. Parafunctional habits such as bruxism and clenching.
  5. Pregnant patients. -

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: Autogenous Dentin Derived Barrier Membrane
Autogenous Dentin Derived Barrier Membrane + Xenogeneic bone graft material+ immediate implant
Procedure: preparation of dentin membrane from hopeless tooth for Guided Bone Regeneration in Immediate Implant
tooth extraction , preparation of dentin membrane ,immediate implantation ,Xenogeneic bone graft material, application of dentin derived barrier membrane
Experimental: Collagen Membrane
Collagen Membrane + Xenogeneic bone graft material + immediate implant
Procedure: Collagen Membrane for Guided Bone Regeneration in Immediate Implant
like group one but with application of collagen membrane

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 year

Collaborators and Investigators

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

Sponsor

Mansoura University

Investigators

  • Study Chair: Heba Elsheikh Assistant professor, Assistant professor, Mansoura University, faculty of dentistry ,Department of Oral and Maxillofacial

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)

April 10, 2022

Primary Completion (Actual)

April 10, 2024

Study Completion (Estimated)

October 10, 2024

Study Registration Dates

First Submitted

September 7, 2024

First Submitted That Met QC Criteria

September 24, 2024

First Posted (Actual)

September 26, 2024

Study Record Updates

Last Update Posted (Actual)

September 26, 2024

Last Update Submitted That Met QC Criteria

September 24, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • A04010222

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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