Alveolar Ridge Preservation Using Amniotic Chorion Membrane

Alveolar Ridge Preservation Using Amniotic Chorion Membrane Alone or Combined With Xenograft (A Randomized Controlled Clinical Trial With Histological Evaluation)

the present study is to compare the amniotic chorion membrane (ACM) alone versus the amniotic chorion membrane combined with xenograft for their efficacy in alveolar ridge preservation procedures regarding volumetric changes assessed by cone beam computed tomography (CBCT).

Study Overview

• Status: Completed
• Conditions: Alveolar Ridge Preservation
• Intervention / Treatment: Other: Amniotic Chorion Membrane and Bio-Oss xenograft; Other: Amniotic Chorion Membrane only

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Ain Shams Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients require extraction of a non-restorable (premolar or anterior tooth) located in the maxillary arch and needs implant restoration.
• Type two sockets will be selected as revealed by Cone beam computed tomography(CBCT)
• Absence of any systemic disease or drugs that contraindicate oral surgery using Modified Cornell Medical Index
• Male and female within age range of 20-45 years.

Exclusion Criteria:

• Smokers.
• Patients with poor oral hygiene or non-compliant patients who are not willing to perform oral hygiene measures.
• Pregnant and breast-feeding females.
• Patients with acute peri-apical infection or sinus tract.
• Vulnerable group of patients as handicapped patients, orphans,prisoners,etc

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Amnoitic Chorion Membrane and xenograft; extraction sockets where ridge preservation will be performed using Chorion Membrane with Xenograft	Other: Amniotic Chorion Membrane and Bio-Oss xenograft; Bioxclude Amniotic Chorion Membrane with xenograft (Bio-Oss) for ridge preservation
Active Comparator: Amnoitic Chorion Membrane only; extraction sockets where ridge preservation will be performed using Chorion Membrane Alone	Other: Amniotic Chorion Membrane only; Bioxclude Amniotic Chorion Membrane only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Bucco-lingual bone width	Bone width will be measured using bone caliper and radiographically	at baseline, 1 months and 4 months
Change in Corono-apical bone height	Bone height using a pre-fabricated stent.	at baseline, 1 months and 4 months
total bone volume change	It will be evaluated by the use of 3D scans of patient dental models	at baseline, and 4 months

Collaborators and Investigators

• Sponsor: Hams Hamed Abdelrahman

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Actual): March 1, 2022
• Study Completion (Actual): June 1, 2024

Study Registration Dates

• First Submitted: March 20, 2021
• First Submitted That Met QC Criteria: March 27, 2021
• First Posted (Actual): April 1, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 4, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: alveolar preservation

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No