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OpenTrials
Completed

NCT Number: NCT05505084

Alveolar Ridge Preservation Following Tooth Extraction.

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.

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Key information

Conditions

Tooth Fractures Caries Stomatognathic Diseases Tooth Diseases Tooth Extraction Status Nos Tooth Injuries Wounds and Injuries

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Penn Dental Medicine

Philadelphia, Pennsylvania, 19104, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tooth extraction and ridge preservation using different barrier mermbranes

Procedure

The hopeless and unrestorable teeth are planned for extraction and implant placement.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Implant site conditions

    Time frame: 4 months post-augmentation

    • Implant stability quotients as determined by resonance frequency analysis.

  2. Implant site conditions

    Time frame: 4 months post-augmentation

    change of the periodontal phenotype

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • ZimVie

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Aug 17, 2022
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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