Ridge Preservation Comparing a Flap Versus Flapless Technique

Alveolar Ridge Preservation Using a Flap Versus Flapless Technique Using a Demineralized Bone Matrix Allograft Plus Mineralized Particulate Allograft and a Calcium Sulfate Barrier

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.

Study Overview

• Status: Completed
• Conditions: Jaw, Edentulous, Partially
• Intervention / Treatment: Procedure: Ridge Preservation

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 Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Procedure: Ridge Preservation; Ridge Preservation using demineralized bone matrix and mineralized particulate allograft and covered with calcium sulfate barrier.
Experimental: Test; The test will be a flapless technique, no flap will be reflected.	Procedure: Ridge Preservation; Ridge Preservation using demineralized bone matrix and mineralized particulate allograft and covered with calcium sulfate barrier.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Crestal Horizontal Ridge Width	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.	4 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	4 months after surgery

Collaborators and Investigators

• Sponsor: University of Louisville
• Investigators: Principal Investigator: Henry Greenwell, DMD, University of Louisville

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2006
• Primary Completion (Actual): May 1, 2007
• Study Completion (Actual): May 1, 2007

Study Registration Dates

• First Submitted: February 12, 2020
• First Submitted That Met QC Criteria: February 13, 2020
• First Posted (Actual): February 17, 2020

Study Record Updates

• Last Update Posted (Actual): June 6, 2023
• Last Update Submitted That Met QC Criteria: June 2, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Mouth Diseases; Tooth Diseases; Jaw Diseases; Mouth, Edentulous; Jaw, Edentulous; Jaw, Edentulous, Partially
• Other Study ID Numbers: 047.06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No