Ridge Preservation Comparing a Flap Versus Flapless Technique

Not Applicable

Completed

• Conditions: Jaw, Edentulous, Partially
• Interventions: Procedure: Ridge Preservation

• Registration Number: NCT04271423
• Lead Sponsor: University of Louisville

Brief Summary

To compare a flapless technique of alveolar ridge preservation to a flap technique to determine if preserving the periosteal blood supply would prevent loss of crestal ridge width and height.

Detailed Description

Twenty-four patients will randomly be assigned to receive ridge preservation using either flapless or flap technique. Twelve test patients will receive ridge preservation using a flapless approach and twelve control patients will receive ridge preservation using a flap technique. All sockets will be grafted with demineralized bone matrix and mineralized particulate allograft and covered with calcium sulfate barrier. Re-entry surgery will be performed at 4 months when a trephine core will be taken from the grafted site immediately prior to implant placement and submitted for histologic processing.

Study Timeline

• Study Start: 2006-04
• Primary Completion: 2007-05
• Study Completion: 2007-05
• Study First Submitted: 2020-02-12
• Study First Submitted QC: 2020-02-13
• Study First Posted: 2020-02-17
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-02
• Last Update Posted: 2023-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1. Have one non-molar tooth requiring extraction that will be replaced with a dental implant where at least one adjacent tooth is present
2. Study subjects at least 18 years old
3. Patients must sign an informed consent approved by the University of Louisville Human Studies Committee of Institutional Review Board.

Exclusion Criteria

1. Patients with debilitating systemic disease, or a disease affects the periodontium
2. Have an allergy to any material or medication used in the study
3. Require prophylactic antibiotics
4. Previous head and neck radiation therapy
5. Chemotherapy in the previous 12 months
6. Patients taking long term Non-steroidal Anti-inflammatory Drugs or steroid therapy
7. Smoked more than one pack of cigarettes per day

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Ridge Preservation	The flap procedure will consist of a full-thickness papilla preservation flap performed on the buccal and a full thickness flap on the palatal.
Test	Ridge Preservation	The test will be a flapless technique, no flap will be reflected.

Primary Outcome Measures

Name	Time	Method
Crestal Horizontal Ridge Width	4 months after surgery	Changes in post-extraction to 4 month change in ridge measurements at the alveolar crest and 5 mm apical to crest. Measurements taken with a caliper.

Secondary Outcome Measures

Name	Time	Method
Percent osseous tissue	4 months after surgery	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