Alveolar Ridge Preservation Using Amniotic Chorion Membrane

• Sponsor: Hams Hamed Abdelrahman (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04824235
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 14.9
• Patients Per Site Per Month: 1.3

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Alveolar Ridge Preservation	Other: Amniotic Chorion Membrane and Bio-Oss xenograft; Other: Amniotic Chorion Membrane only	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Alveolar Ridge Preservation Using Amniotic Chorion Membrane Alone or Combined With Xenograft (A Randomized Controlled Clinical Trial With Histological Evaluation)
• Actual Study Start Date: Dec 1, 2020
• Anticipated Primary Completion Date: Mar 1, 2022
• Anticipated Study Completion Date: Mar 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change in Bucco-lingual bone width [at baseline, 1 months and 4 months]

   Bone width will be measured using bone caliper and radiographically

2. Change in Corono-apical bone height [at baseline, 1 months and 4 months]

   Bone height using a pre-fabricated stent.

3. total bone volume change [at baseline, and 4 months]

   It will be evaluated by the use of 3D scans of patient dental models

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ain Shams Faculty of Dentistry	Cairo		Egypt

Sponsors and Collaborators

• Hams Hamed Abdelrahman

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hams Hamed Abdelrahman, Assistant lecturer of DPH and Clinical statistician, Alexandria University
• ClinicalTrials.gov Identifier: NCT04824235
• Other Study ID Numbers: alveolar preservation
• First Posted: Apr 1, 2021
• Last Update Posted: Apr 1, 2021
• Last Verified: Mar 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Apr 1, 2021