Ridge Preservation Comparing the Clinical and Histologic Healing of Flap vs. Flapless Approach to Grafting

NCT ID: NCT02487758

Last Updated: 2016-12-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2016-05-31

Brief Summary

Ridge Preservation Comparing the Clinical and Histologic Healing of Flap vs. Flapless Approach to Grafting

Detailed Description

Thirty patients will be treated using the principles of guided bone regeneration and ridge preservation. Fifteen test patients will receive the flapless technique with an intrasocket cancellous cortical particulate allograft plus a facial overlay graft using a bovine xenograft plus Alloderm GBR. The positive control group of fifteen patients will receive the flap technique with an intrasocket cancellous cortical particulate allograft plus a facial overlay graft using a bovine xenograft plus Alloderm GBR. Approximately, four months post-surgery, a trephine core will be taken from the grafted site immediately prior to implant placement and submitted for histologic processing.

Conditions

Jaw, Edentulous, Partially

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Ridge preservation Flap

The flap procedure will consist of a full-thickness papilla preservation flap performed on the buccal and a full thickness flap on the palatal.

Group Type: EXPERIMENTAL

Ridge Preservation

Intervention Type: PROCEDURE

Ridge Preservation Comparing the Clinical and Histologic Healing of Flap vs. Flapless Approach to Grafting

Ridge preservation Flapless

The test will be a flapless technique with tunneling and an intramucosal vertical incision on the buccal.

Group Type: EXPERIMENTAL

Ridge Preservation

Intervention Type: PROCEDURE

Ridge Preservation Comparing the Clinical and Histologic Healing of Flap vs. Flapless Approach to Grafting

Interventions

Ridge Preservation

Ridge Preservation Comparing the Clinical and Histologic Healing of Flap vs. Flapless Approach to Grafting

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Have one non-molar tooth requiring extraction that will be replaced by a dental implant. The site must be bordered by at least one tooth.

2. Healthy male or female who is at least 18 years old.

3. Patients must sign an informed consent approved by the University of Louisville Human Studies Committee.

Exclusion Criteria

1. Patients with debilitating systemic diseases, or diseases that have a clinically significant effect on the periodontium.

2. Presence or history of osteonecrosis of jaws.

3. Patients who are currently taking IV bisphosphonates or who had IV treatment with bisphosphonates irrespective of duration.

4. Patients who have been treated with oral bisphosphonates for more than three years.

5. Patients with an allergy to any material or medication used in the study.

6. Previous head and neck radiation therapy.

7. Chemotherapy in the previous 12 months.

8. Pregnant patients.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Louisville

OTHER

Sponsor Role: lead

Responsible Party

Henry Greenwell

Graduate Periodontics Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Henry Greenwell, DMD

Role: PRINCIPAL_INVESTIGATOR

University of Louisville

Other Identifiers

15.0531

Identifier Type: -

Identifier Source: org_study_id