Evaluation of Healing at Molar Extraction Sites With and Without Ridge Preservation

NCT02543398 | Completed Results

• 1 other identifier: HSC20130470H
• Study Type: interventional
• Target: 52
• Locations: 0 countries
• Sites: N/A

Brief 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?

Conditions

Loss of Teeth Due to Extraction

Outcome Measures

Primary Outcomes (1)

• Radiographic Bone Changes

  The width and the height of the alveolar ridge will be measured (in mm) on the initial (i.e. following tooth extraction) Cone Beam CT and on the CBCT taken prior to implant placement (i.e. 3 months after tooth extraction)

  3 months after tooth extraction

Study Arms (2)

Ridge preservation

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"

Procedure: Ridge preservation

No ridge preservation

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)

Procedure: Ridge preservation

Interventions

Ridge preservation PROCEDURE

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.

No ridge preservation; Ridge preservation

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead
• Osteogenics Biomedical: collaborator

Related Publications (1)

• Walker CJ, Prihoda TJ, Mealey BL, Lasho DJ, Noujeim M, Huynh-Ba G. Evaluation of Healing at Molar Extraction Sites With and Without Ridge Preservation: A Randomized Controlled Clinical Trial. J Periodontol. 2017 Mar;88(3):241-249. doi: 10.1902/jop.2016.160445. Epub 2016 Oct 27.

  PMID: 27788625 DERIVED

Results Point of Contact

• Title: Guy Huynh-Ba
• Organization: UTHSCSA Periodontics

huynhba@uthscsa.edu

2105673569

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2015
• First Posted: September 7, 2015
• Study Start: October 1, 2013
• Primary Completion: May 1, 2016
• Study Completion: July 1, 2016
• Last Updated: June 28, 2018
• Results First Posted: November 1, 2017

Record last verified: 2017-05