Ridge Preservation Comparing the Healing With or Without a Barrier Membrane

Jaw, Edentulous, Partially Clinical Trial

Official title:

Ridge Preservation Comparing the Clinical and Histologic Healing of Membrane vs. no Membrane Approach to Grafting.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02798887
• Other study ID #: 16.0461
• Status: Completed
• Phase: N/A
• Start date: August 24, 2016
• Est. completion date: May 18, 2017

Study information

• Verified date: September 2020
• Source: University of Louisville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Ridge Preservation Comparing the Clinical and Histologic Healing of Membrane vs. no Membrane Approach to Grafting.

Description:

Thirty patients will be treated using the principles of bone grafting for ridge preservation. Fifteen test patients will receive a flap technique with an intrasocket cancellous cortical particulate allograft plus a facial overlay graft using a bovine xenograft without a membrane where only the exposed intrasocket allograft will be covered with a piece of Alloderm GBR. The positive control group of fifteen patients will receive a flap technique with an intrasocket cancellous cortical particulate allograft plus a facial overlay graft using a bovine xenograft plus Alloderm GBR membrane. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 18, 2017
• Est. primary completion date: May 18, 2017
• 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 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. Patients who need prophylactic antibiotics

7. Previous head and neck radiation therapy.

8. Chemotherapy in the previous 12 months.

9. Patients on long term NSAID or steroid therapy.

10. Pregnant patients.

Related Conditions & MeSH terms

• Jaw, Edentulous
• Jaw, Edentulous, Partially

Intervention

Procedure:
• Ridge preservation
Ridge preservation comparing the clinical and histologic healing with or without a barrier membrane

Locations

Country	Name	City	State
United States	Graduate Periodontics Clinic University of Louisville	Louisville	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
University of Louisville

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 months
Secondary	Change in Soft tissue thickness	Soft tissue thickness measurements taken with a #40 endodontic reamer.	4 months
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