Alveolar Ridge Preservation Following Tooth Extraction.

May 4, 2026 updated by: Yucheng Chang, University of Pennsylvania

Comparison of Five Distinct Membranes for Preservation of the Alveolar Ridge Following Tooth Extraction: A Prospective, Randomized, Controlled Clinical Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The extraction and the grafting procedure involved in this study are standard of care. The investigators will extract the hopeless teeth and prepare the site for implant placement in 4 months.

The following products will be used during the study:

  • Collatape (Zimmer Dental)- approved by the FDA (class III)
  • Cytoplast (Osteogenics Biomedical)- cleared by the FDA
  • OssixPlus (Dantum Dental)- cleared by the FDA
  • Renovix-Plus (Salvin)- cleared by the FDA
  • BioXclude (SNOASIS)-certificate from the American Association of Tissue Banking
  • PuroⓇ, Zimmer Dental)- cleared by the FDA
  • RegenerOssⓇ, Zimmer Dental) - cleared by the FDA

During the appointment for the implant placement. A bone core from all subjects in each treatment group will be collected from the augmentation site instead of drilling away. The sample will be evaluated for the following:

  • % viable of bone
  • % of connective tissue
  • % of residual graft material

Study Type

Observational

Enrollment (Actual)

47

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Penn Dental Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

The study population will consist of subjects presenting to the University of Pennsylvania School of Dental Medicine who require extraction of a hopeless tooth due to trauma, caries, or endodontic/periodontal reasons, and who are interested in replacing their tooth with a dental implant.

Description

Inclusion Criteria:

  • Subjects must between the ages of 18 and 80.
  • Subjects must require removal of at least one maxillary premolar
  • Subjects should benefit from an implant-supported crown.
  • Subjects must have voluntarily signed the informed consent form.
  • Subjects must be assessed as ASA I, ASA II by a member of the research team.

Exclusion Criteria:

  • Medical conditions requiring the use of steroids.
  • History of leukocyte dysfunction or deficiencies, bleeding deficiencies, renal failure, uncontrolled endocrine disorders, acquired immunodeficiency syndrome or hepatitis.
  • History of neoplastic disease requiring the use of chemotherapy or irradiation to head and neck.
  • Subjects who have diabetes mellitus.
  • Subjects who have undergone administration of any investigational drug or device within 30 days of enrollment in the study.
  • Alcohol or drug abuse.
  • Subjects who are heavy smokers (greater than 10 cigarettes per day or cigar equivalents) or chew tobacco.
  • Conditions or circumstances, in the opinion of the research team, which would prevent completion of study participation or interfere with analysis of study results, such as a history of non-compliance or unreliability.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Procedure: Tooth extraction and ridge preservation using different barrier mermbranes
The hopeless and unrestorable teeth are planned for extraction and implant placement.
Cytoplast Barrier Membranes TXT-200 Singles (Osteogenics Biomedical)
Cytoplast Barrier membranes are manufactured from high-density Polytetrafluoroethylene (PTFE) which allows them to withstand exposure to the oral environment. The textured surface increases the surface area available for cellular attachment during dental bone grafting procedures thereby aiding in stabilizing the PTFE membrane. It can be removed non-surgically after at least 21 days.
Procedure: Tooth extraction and ridge preservation using different barrier mermbranes
The hopeless and unrestorable teeth are planned for extraction and implant placement.
Ossix Plus (dantum dental)
OssixPlus is a resorbable collagen dental membrane used for Guided Bone Regeneration and Guided Tissue Regeneration. It contains a patented GLYMATRIX cross-linking technology that allows it to maintain barrier functionality for 4 to 6 months. The collagen is derived from porcine.
Procedure: Tooth extraction and ridge preservation using different barrier mermbranes
The hopeless and unrestorable teeth are planned for extraction and implant placement.
Renovix-Plus (Salvin)
Renovix Plus is a non-cross-linked extracellular matrix containing Type I, II, and III Collagen, Fibronectin, Laminin, and Elastin. It provides architecture and barrier protection for bone regeneration and soft tissue esthetics. This membrane resorbs within six months.
Procedure: Tooth extraction and ridge preservation using different barrier mermbranes
The hopeless and unrestorable teeth are planned for extraction and implant placement.
BioXclude (Snoasis)
BioXclude is a minimally manipulated allograft amnion chorion tissue. It is obtained from consenting mothers who donate their placentas after elective caesarian section delivery. The tissue is processed to cleanse and maintain the tissue. Following processing and dehydration, the allografts are packaged and terminally sterilized.
Procedure: Tooth extraction and ridge preservation using different barrier mermbranes
The hopeless and unrestorable teeth are planned for extraction and implant placement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ridge dimension changes before and after the augmentation.
Time Frame: from the date of the extraction 4 months
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
Time Frame: 4 months post-augmentation
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implant site conditions
Time Frame: 4 months post-augmentation
- Implant stability quotients as determined by resonance frequency analysis.
4 months post-augmentation
Implant site conditions
Time Frame: 4 months post-augmentation
change of the periodontal phenotype
4 months post-augmentation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Collaborators

ZimVie

Investigators

  • Principal Investigator: Yu-Cheng Chang, DMD, University of Pennsylvania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2022

Primary Completion (Actual)

December 31, 2025

Study Completion (Actual)

December 31, 2025

Study Registration Dates

First Submitted

June 1, 2022

First Submitted That Met QC Criteria

August 15, 2022

First Posted (Actual)

August 17, 2022

Study Record Updates

Last Update Posted (Actual)

May 8, 2026

Last Update Submitted That Met QC Criteria

May 4, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 828879

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Caries

Clinical Trials on Tooth extraction and ridge preservation using different barrier mermbranes

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahamas

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe