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

University of Louisville24 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Jaw, Edentulous, Partially

Interventions

Ridge PreservationPROCEDURE

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

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Change in post-extraction site to 4 month change in crestal osseous width

Changes in post-extraction to 4 month change in ridge measurements at the mid-defect alveolar crest and 5 mm apical taken with a caliper.

Time frame: 4 months

Secondary Outcomes

Change in Soft tissue thickness

Soft tissue thickness measurements taken with a #40 endodontic reamer.

Time frame: 4 months

Percent osseous tissue

A trephine core will be harvested at 4 months. Following histologic processing the osseous core will be classified into percent vital bone, nonvital bone and trabecular space.

Time frame: 4 months

Data from ClinicalTrials.gov

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