Ridge Preservation Comparing the Healing With or Without a Barrier Membrane

NCT02798887 | Completed

• 1 other identifier: 16.0461
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Jaw, Edentulous, Partially

Keywords

Regeneration; Bone regeneration; Grafting, Bone; Allograft; Xenograft

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in Soft tissue thickness

  4 months

• Percent osseous tissue

  4 months

Study Arms (2)

Ridge preservation membrane

EXPERIMENTAL

Positive control Patients will receive ridge preservation intrasocket allograft and overlay xenograft resorbable with membrane

Procedure: Ridge preservation

Ridge preservation no membrane

EXPERIMENTAL

test patients will receive ridge preservation intrasocket allograft and overlay xenograft with no membrane

Procedure: Ridge preservation

Interventions

Ridge preservation PROCEDURE

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

Ridge preservation membrane; Ridge preservation no membrane

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Healthy male or female who is at least 18 years old.
• Patients must sign an informed consent approved by the University of Louisville Human Studies Committee.

You may not qualify if:

• Patients with debilitating systemic diseases, or diseases that have a clinically significant effect on the periodontium.
• Presence or history of osteonecrosis of jaws.
• Patients who are currently taking IV bisphosphonates or who had IV treatment with bisphosphonates irrespective of duration.
• Patients who have been treated with oral bisphosphonates for more than three years.
• Patients with an allergy to any material or medication used in the study.
• Patients who need prophylactic antibiotics
• Previous head and neck radiation therapy.
• Chemotherapy in the previous 12 months.
• Patients on long term NSAID or steroid therapy.
• Pregnant patients.

Sponsors & Collaborators

• University of Louisville: lead

Study Sites (1)

Graduate Periodontics Clinic University of Louisville

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Conditions

Jaw, Edentulous, Partially

Condition Hierarchy (Ancestors)

Jaw, Edentulous; Jaw Diseases; Musculoskeletal Diseases; Stomatognathic Diseases; Mouth, Edentulous; Mouth Diseases; Tooth Diseases

Study Officials

• Henry Greenwell, DMD, MSD

  University of Louisville

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 9, 2016
• First Posted: June 14, 2016
• Study Start: August 24, 2016
• Primary Completion: May 18, 2017
• Study Completion: May 18, 2017
• Last Updated: September 10, 2020

Record last verified: 2020-09

Locations

US (1)