Brief Summary

Bone resorption after a tooth extraction is a generally accepted knowledge and has been demonstrated by many animal and human studies. Especially during the first three months followed by the tooth extraction, the volume of bone may change significantly without any interference. Thus, doing a ridge preservation procedure following the extraction is a common standard of care method to maintain the socket volume if implant placement is considered as a treatment option in the future. A variety of materials and methods have been used for ridge preservation. However, it's still inconclusive to determine the best material to maintain the ridge dimension, especially for membrane placement that allows for space maintenance to protect the grafting material. Furthermore, there is no evidence to show any treatment rationale is superior to any other ridge preservation method. In general, the membrane serves the function of the barrier and space protector. The periodontal surgeon use membranes to exclude the epithelium growth and to limit the collapse of the soft tissue into the healing alveolar socket. Regarding resorbable and non-resorbable membrane materials, both serve the function of protecting the graft material from the oral cavity. However, there are also many demonstrating that without membranes the extraction socket healed nicely without any interferences. The question to us is: Do we need the membrane to exclude the epithelium or any kind of surgical dressing material is sufficient enough to preserve the volume of the extracted ridge? The object of this study is to compare five popular membranes on the market that present different characteristics of the membranes.

Trial Health

Monitor

Trial Health Score

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

Trial has exceeded expected completion date

Enrollment

participants targeted

Target at P25-P50 for all trials

Timeline

Completed

Started Aug 2022

Typical duration for all trials

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

3.4 years study duration

First Submitted

Initial submission to the registry

June 1, 2022

Completed

3 months until next milestone

Study Start

First participant enrolled

August 15, 2022

Completed

2 days until next milestone

First Posted

Study publicly available on registry

August 17, 2022

Completed

3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed

Last Updated

April 25, 2025

Status Verified

April 1, 2025

Enrollment Period

3.4 years

First QC Date

June 1, 2022

Last Update Submit

April 22, 2025

Conditions

Tooth Fractures Tooth Extraction Status Nos Caries

Keywords

implantalveolar ridge preservation

Outcome Measures

Primary Outcomes (2)

Ridge dimension changes before and after the augmentation.
The change in alveolar ridge dimensions will be assessed using CBCT technology after extraction and 4 months after extraction.
from the date of the extraction 4 months
Histological Evaluation
A bone core from all subjects in each treatment group will be taken from the augmentation site at the time of implant placement (4 months post-augmentation) and will be evaluated for the composition of the specimen.
4 months post-augmentation

Secondary Outcomes (2)

Implant site conditions
4 months post-augmentation
Implant site conditions
4 months post-augmentation

Study Arms (5)

Collatape (Zimmer Dental)

This material is a resorbable collagen wound dressing. They are made from bovine Achilles tendons and are a source of Type I collagen. The resorbable wound dressings are sterilized after purification with ethylene oxide.