Ridge Preservation Comparing the Healing With or Without a Barrier Membrane

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

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

Study Overview

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

Detailed 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.

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

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Graduate Periodontics Clinic University of Louisville

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ridge preservation membrane; Positive control Patients will receive ridge preservation intrasocket allograft and overlay xenograft resorbable with membrane	Procedure: Ridge preservation; Ridge preservation comparing the clinical and histologic healing with or without a barrier membrane
Experimental: Ridge preservation no membrane; test patients will receive ridge preservation intrasocket allograft and overlay xenograft with no membrane	Procedure: Ridge preservation; Ridge preservation comparing the clinical and histologic healing with or without a barrier membrane

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Soft tissue thickness	Soft tissue thickness measurements taken with a #40 endodontic reamer.	4 months
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): August 24, 2016
• Primary Completion (Actual): May 18, 2017
• Study Completion (Actual): May 18, 2017

Study Registration Dates

• First Submitted: June 9, 2016
• First Submitted That Met QC Criteria: June 9, 2016
• First Posted (Estimate): June 14, 2016

Study Record Updates

• Last Update Posted (Actual): September 10, 2020
• Last Update Submitted That Met QC Criteria: September 8, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Allograft; Grafting, Bone; Bone regeneration; Xenograft; Regeneration
• 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: 16.0461

Drug and device information, study documents

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