Soft Tissue Healing During Alveolar Ridge Preservation

April 14, 2025 updated by: Ain Shams University

Assessment of the Effect of Covered Versus Uncovered Human Amniotic Membrane In Soft Tissue Healing During Alveolar Ridge Preservation: A Randomized Controlled Trial

Statement of the problem: Alveolar ridge preservation after tooth extractions is considered a challenge in oral surgery daily practice. Dental extraction is a traumatic procedure which leads to loss of alveolar bone. The alveolar bone remodeling, which occurs after tooth extraction, leads to vertical and horizontal bone volume loss. Although placentally derived allografts have been widely applied in medical procedures over the past 100 years, their use in the dental field is relatively new.

The aim of this study is to compare the effect of covering versus uncovering the HAM on soft tissue healing after alveolar ridge preservation procedure using customized splints.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The aim of this study is to compare the effect of covering versus uncovering the HAM on soft tissue healing after alveolar ridge preservation procedure using customized splints.

materials and methods: Careful extraction of the selected tooth will be performed. Then, the extraction sockets will be randomly allocated into two groups. The HAM particulate will be packed into the extraction socket as a standard method for both groups. Group A (n=24) socket will be covered with Human amnion membrane while group B (n=24) socket will be covered with the prefabricated acrylic splint. 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)

48

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, 23568
        • 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 teeth extractions.

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
Active Comparator: Acrylic splint .
●The HAM particulate material will be packed into the extraction socket then the HAM will be tucked over the extraction socket then the socket plug will be maintained in place with approximating sutures using 5-0 resorbable suture material. The surgical site covered with the custom acrylic splint.
Active Comparator: No splint .
The HAM particulate material will be packed into the extraction socket then the HAM will be tucked over the extraction socket then the socket plug will be maintained in place with approximating sutures using 5-0 resorbable suture material. The surgical site will not be covered by splint.

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 in mm
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
post operative pain
Time Frame: every day for the first week, day after day second week, once in third and fourth week
Visual analog score ( score from 0 to 10 in which 0 is no pain and 10 is maximum pain )
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 1, 2025

Study Completion (Estimated)

August 1, 2025

Study Registration Dates

First Submitted

April 4, 2025

First Submitted That Met QC Criteria

April 14, 2025

First Posted (Actual)

April 15, 2025

Study Record Updates

Last Update Posted (Actual)

April 15, 2025

Last Update Submitted That Met QC Criteria

April 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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