Ridge Preservation Comparing a Flap Versus Flapless Technique

NCT ID: NCT04271423

Last Updated: 2023-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-04-30
• Study Completion Date: 2007-05-31

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.

Conditions

Jaw, Edentulous, Partially

Study Design

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

Study Groups

Control

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: ACTIVE_COMPARATOR

Ridge Preservation

Intervention Type: PROCEDURE

Ridge Preservation using demineralized bone matrix and mineralized particulate allograft and covered with calcium sulfate barrier.

Test

The test will be a flapless technique, no flap will be reflected.

Group Type: EXPERIMENTAL

Ridge Preservation

Intervention Type: PROCEDURE

Ridge Preservation using demineralized bone matrix and mineralized particulate allograft and covered with calcium sulfate barrier.

Interventions

Ridge Preservation

Ridge Preservation using demineralized bone matrix and mineralized particulate allograft and covered with calcium sulfate barrier.

Intervention Type: PROCEDURE

Eligibility Criteria

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

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

Sponsors

University of Louisville

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Henry Greenwell, DMD

Role: PRINCIPAL_INVESTIGATOR

University of Louisville

Other Identifiers

047.06

Identifier Type: -

Identifier Source: org_study_id