NCT06835543

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
190

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 7, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 14, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 19, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 7, 2025

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

February 19, 2025

Status Verified

January 1, 2025

Enrollment Period

6 months

First QC Date

February 14, 2025

Last Update Submit

February 14, 2025

Conditions

Keywords

Amnion membranechorion membranesoft tissue healingtooth extraction

Outcome Measures

Primary Outcomes (1)

  • Soft tissue healing

    Surface area/intraoral scanner

    every day for the first week, day after day second week, once in third and fourth week

Secondary Outcomes (1)

  • Healing index

    every day for the first week, day after day second week, once in third and fourth week

Study Arms (2)

Amnion membrane

ACTIVE COMPARATOR

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.

Chorion membrane.

ACTIVE COMPARATOR

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

Interventions

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

Amnion 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.

Chorion membrane.

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

faculty of oral and dental medicine , Suez university

Suez, Suez Governorate, 123456, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2025

First Posted

February 19, 2025

Study Start

January 7, 2025

Primary Completion

July 7, 2025

Study Completion

August 1, 2025

Last Updated

February 19, 2025

Record last verified: 2025-01

Locations