Ridge Preservation Comparing a Flap Versus Flapless Technique

Jaw, Edentulous, Partially Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04271423
• Other study ID #: 047.06
• Status: Completed
• Phase: N/A
• Start date: April 2006
• Est. completion date: May 2007

Study information

• Verified date: June 2023
• Source: University of Louisville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Jaw, Edentulous
• Jaw, Edentulous, Partially

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Louisville

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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