Socket Preservation Using Dentin Graft Autogenous Dentin Graft With Collagen Sponge on Dental Implant Stability AUTOGENOUS TOOTH GRAFT WITH COLLAGEN SPONGE ON DENTAL IMPLANT STABILITY

February 27, 2025 updated by: Amira Ali El said, Faculty of Dental Medicine for Girls

Evaluation of Socket Preservation Using Autogenous Dentin Graft With Collagen Sponge on Dental Implant Stability

The present study was performed to evaluate socket preservation using collagen sponge with autogenous dentin graft versus collagen sponge with de-mineralised freez-dried bone graft on dental implant stability

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

in our study we made socket preservation using two different grafts in two groups.

before grafting we took CBCT

we used autogenous dentin graft covered by collagen sponge in one group and demineralized freeze - dried allograft covered with collagen sponge in the other group.

after 6 months we Took another CBCT to assist the dimensional changes and bone density in the alveolar socket after grafting We inserted the implant and during insertion we took a core biopsy with trephine bur with external diameter 3 mm for histological analysis.

After implant insertion we assisted the stability using RFA.

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 3

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
      • Cairo, Egypt
        • Al Azhar University for girls

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:

  • Patients are free from any systemic diseases.
  • Patients with good oral hygiene.
  • Age range from 25-50 years.
  • Adequate inter arch space .

Exclusion Criteria:

  • Medications that may affect bone turnover, and bone metabolic diseases.
  • Smoker patients and alcoholics.
  • Patients with parafunctional habits.
  • Patients with active acute infection related to tooth of interest.
  • Patients with a lack of compliance, and serious mental or psychological problems.
  • Pregnant females.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: demineralized freeze dried allograft
demineralized freeze dried allograft with collagen sponge
Combination product: Demineralized freeze dried allograft with collagen sponge
Demineralized freeze dried allograft,filling 2/3 of the socket covered with collagen sponge ,six months, one time
Other Names:
  • DFDBA
Active Comparator: autogenous dentin graft
Autogenous dentin graft with collagen sponge
Combination product: autogenous dentin graft with collagen sponge
autogenous mineralized dentin graft, filling 2/3 of the socket covered with collagen sponge , six months, one time
Other Names:
  • ADG

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in radiographic Socket dimensions from base line to 6 months
Time Frame: 6 months following the end of treatment
CBCT measuring socket dimensions
6 months following the end of treatment
change in bone density from base line to 6 months
Time Frame: 6 months following the end of treatment
CBCT measuring bone density within the socket
6 months following the end of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
new bone formation
Time Frame: after six months at the time of implant placement
Histological analysis for new bone formation by masson trichrome
after six months at the time of implant placement
implant stability
Time Frame: after six months at the time of implant placement
measuring primary Implant Stability by resonance frequency analysis
after six months at the time of implant placement

Collaborators and Investigators

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

Sponsor

Faculty of Dental Medicine for Girls

Collaborators

Beni-Suef University

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)

September 15, 2023

Primary Completion (Actual)

April 1, 2024

Study Completion (Actual)

June 1, 2024

Study Registration Dates

First Submitted

February 27, 2025

First Submitted That Met QC Criteria

February 27, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 27, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P-ME-23-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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