Alveolar Ridge Preservation Using Amniotic Chorion Membrane
1 other identifier
interventional
20
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2020
Longer than P75 for not_applicable
1 active site
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
December 1, 2020
CompletedFirst Submitted
Initial submission to the registry
March 20, 2021
CompletedFirst Posted
Study publicly available on registry
April 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2024
CompletedJanuary 7, 2025
January 1, 2025
1.2 years
March 20, 2021
January 4, 2025
Conditions
Outcome Measures
Primary Outcomes (3)
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
Study Arms (2)
Amnoitic Chorion Membrane and xenograft
EXPERIMENTALextraction sockets where ridge preservation will be performed using Chorion Membrane with Xenograft
Amnoitic Chorion Membrane only
ACTIVE COMPARATORextraction sockets where ridge preservation will be performed using Chorion Membrane Alone
Interventions
Bioxclude Amniotic Chorion Membrane with xenograft (Bio-Oss) for ridge preservation
Bioxclude Amniotic Chorion Membrane only
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ain Shams Faculty of Dentistry
Cairo, Egypt
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant lecturer of DPH and Clinical statistician
Study Record Dates
First Submitted
March 20, 2021
First Posted
April 1, 2021
Study Start
December 1, 2020
Primary Completion
March 1, 2022
Study Completion
June 1, 2024
Last Updated
January 7, 2025
Record last verified: 2025-01