Overview

This trial is active, not recruiting.

Condition loss of teeth due to extraction
Treatment ridge preservation
Sponsor The University of Texas Health Science Center at San Antonio
Collaborator Osteogenics Biomedical
Start date October 2013
End date May 2016
Trial size 52 participants
Trial identifier NCT02543398, HSC20130470H

Summary

Following tooth extraction ridge preservation procedure have been suggested to limit bone resorptive dimensional changes to facilitate prospective implant placement. While this is particularly true for anterior teeth, no evidence is available to establish clinical guidelines in posterior sites, i.e. following molar extraction.

This research project will answer the following question:

What are the dimensional changes of the hard and soft tissues encountered following molar extractions with and without ridge preservation?

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Other)
The molar extraction socket is grafted with FDA approved materials, which includes a bone graft material derived from human donors (enCore®, Osteogenics biomedical, Lubbock, TX) and a membrane (like a thin sheet of paper) covering the grafted extraction socket. The membrane used will need to be removed at a later point since it is non-resorbable (it will not "dissolve" by itself). This membrane is made of dense polytetrafluoroethylene (dPTFE) (Cytoplast™, Osteogenics biomedical, Lubbock, TX). The procedure is called "Ridge preservation"
ridge preservation
Ridge preservation is a procedure which consists in grafting the tooth extraction socket with a bone grafting material and cover the site with a membrane to protect the site.
(Other)
The molar extraction socket is left to heal by itself without any grafting material or membrane, i.e. "Spontaneous Healing" (No ridge preservation is performed)
ridge preservation
Ridge preservation is a procedure which consists in grafting the tooth extraction socket with a bone grafting material and cover the site with a membrane to protect the site.

Primary Outcomes

Measure
Radiographic bone changes
time frame: 3 months after tooth extraction

Eligibility Criteria

Male or female participants at least 21 years old.

Inclusion Criteria: - Patients will be included in this study if they qualify the following inclusion criteria: - One molar tooth that has been identified by dental faculty as requiring a single tooth extraction - A dental implant is indicated and treatment planned to replace the missing molar tooth - Have adequate restorative space for a dental implant-retained restoration - Have at least 10mm of alveolar bone height, without impinging on the maxillary sinus or inferior alveolar canal. Exclusion Criteria: - Obvious exclusions are patients who do not meet all the inclusion criteria or who will not cooperate with the follow-up schedule. - Patients will not be entered who are mentally incompetent, prisoners, or pregnant. - Pregnant women or women intending to become pregnant during the study period. As standard practice prior to dental surgery, females of child-bearing age are asked verbally if there is any possibility that they are pregnant. If not, we proceed with surgery and no pregnancy test is done. If the woman states that there is a possibility that she is pregnant, we do a urine pregnancy test to rule pregnancy in or out. So use of the urine pregnancy test is only done if she says she may be pregnant. [If needed: An over-the-counter urine pregnancy test will be provided to female subjects in the graduate periodontics clinic of UTHSCSA. Patients will be allowed access to a private restroom and the results of the tests will be read by one of the named investigators. Only those with a negative pre-operative pregnancy test will be eligible for the study.] Female patients who have undergone a hysterectomy, tubal ligation or menopause will be excluded from pregnancy testing. - Patients who become pregnant during the study will be withdrawn and standard care will be delivered. - Clinical and/or radiographic determinations which will preclude inclusion in this study are: - Active localized or systemic infection other than periodontitis. - Untreated periodontal diseases - Inadequate bone dimensions or restorative space dimensions to place a dental implant - Presence of a disease entity, medical condition or therapeutic regimen which decreases probability of soft tissue and bony healing, e.g., poorly controlled diabetes, chemotherapeutic and immunosuppressive agents, or autoimmune diseases. - Positive medical history of endocarditis following oral or dental surgery.

Additional Information

Official title Evaluation of Healing at Molar Extraction Sites With and Without Ridge Preservation
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by The University of Texas Health Science Center at San Antonio.