Soft Tissue Healing After Tooth Extraction

February 14, 2025 updated by: Ain Shams University

Assessment of Amnion Membrane Versus Chorion Membrane for Soft Tissue Healing After Tooth Extraction; a Randomized Clinical Trial

Statement of the problem: Tooth extraction results in hard and soft tissue loss which complicates prosthodontic rehabilitation, So different techniques of alveolar ridge preservation should be done to maintain hard and soft tissue dimensions.

Aim: The aim of this study is to compare the effect of amnion membrane versus chorion membrane on soft tissue healing among socket preservation procedure.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Aim: The aim of this study is to compare the effect of amnion membrane versus chorion membrane on soft tissue healing among socket preservation procedure.

Materials and Methods: This parallel arm, randomized controlled clinical trial will involve systemically free patients with remaining roots or badly decayed teeth in the posterior region not indicated for immediate implant placement. They will be randomly allocated to two equal groups. Group A (n=95) socket will be grafted with HAM particulate and the socket will be covered with amnion membrane, and group B (n=95) socket will be grafted with HAM particulate and the socket will be covered with chorion membrane. Soft tissue healing will be assessed (1ry outcome) every day for the first week, day after day second week, once in third and fourth week. Postoperative pain and swelling will be recorded daily by the patient for the 1st two weeks post surgically. Postoperative medication will be prescribed to the patient and postoperative instructions will be explained in detail. Follow-up will be performed to assess the parameters and to ensure performing proper oral hygiene. Data collected will be tabulated and statistically analyzed.

Study Type

Interventional

Enrollment (Estimated)

190

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
      • Suez, Egypt, 123456
        • faculty of oral and dental medicine , Suez university

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. Patients who need simple extraction not indicated for immediate implant placement.

Exclusion Criteria:

  1. Patients with inability or anticipated failure to maintain adequate oral hygiene.
  2. Pregnant or breast-feeding mothers.
  3. Any medical condition or therapy that can affect healing.

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Amnion membrane
the amnion membrane tucked over the extraction socket then the socket plug will be maintained in place with approximating sutures using 5-0 resorbable suture material
Procedure: Amnion membrane.
the amnion membrane tucked over the extraction socket then the socket plug will be maintained in place with approximating sutures using 5-0 resorbable suture material
Active Comparator: Chorion membrane.
chorion membrane (Bioxclude , Snoasis Medical , USA) tucked over the extraction socket then the socket plug will be maintained in place with approximating sutures using 5-0 resorbable suture material.
Procedure: Chorion membrane
chorion membrane tucked over the extraction socket then the socket plug will be maintained in place with approximating sutures using 4-0 resorbable suture material.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Soft tissue healing
Time Frame: every day for the first week, day after day second week, once in third and fourth week
Surface area/intraoral scanner
every day for the first week, day after day second week, once in third and fourth week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Healing index
Time Frame: every day for the first week, day after day second week, once in third and fourth week
Score (from o to 10, were 0 is no healing and 10 complete healing of tissue )
every day for the first week, day after day second week, once in third and fourth week

Collaborators and Investigators

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

Sponsor

Ain Shams 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)

January 7, 2025

Primary Completion (Estimated)

July 7, 2025

Study Completion (Estimated)

August 1, 2025

Study Registration Dates

First Submitted

February 14, 2025

First Submitted That Met QC Criteria

February 14, 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 14, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Soft Tissue Healing

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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