Soft Tissue Healing After Tooth Extraction

NCT ID: NCT06835543

Last Updated: 2025-02-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

190 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-07

Study Completion Date

2025-08-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Badly Broken Maxillary Premolars Indicated for Extraction Badly Broken Down Vital Teeth

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
blinding of outcome assessors and participants will be achieved as the different outcomes will be assessed for all groups by assessors other than the researchers doing the procedures.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type ACTIVE_COMPARATOR

Amnion membrane.

Intervention Type PROCEDURE

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

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.

Group Type ACTIVE_COMPARATOR

Chorion membrane

Intervention Type PROCEDURE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

faculty of oral and dental medicine , Suez university

Suez, Suez Governorate, Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

soft tissue healing

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.