Implant Placement and Simultaneous Soft Tissue Grafting With Single or Double Layers of Acellular Dermal Matrix: A Randomized, Controlled Clinical Tria.

University of Louisville1 site in 1 country26 target enrollmentNovember 2012

ConditionsClinical Efficacy

Overview

Phase: N/A
Intervention: Not specified
Conditions: Clinical Efficacy
Sponsor: University of Louisville
Enrollment: 26
Locations: 1
Primary Endpoint: Soft tissue thickness.
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to compare the effect on soft tissue thickness of placing either a single or double layer of acellular dermal matrix simultaneous with dental implant placement. The hypothesis is that 2 layers of acellular dermal matrix will produce thicker tissues that one layer.

Detailed Description

Patients must be greater that 18 years old, not pregnant, and have an edentulous space with a tooth on each side that is treatment planned to receive a dental implant. The primary outcome measure is soft tissue thickness.

Registry

clinicaltrials.gov

Start Date

November 2012

End Date

June 2013

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Louisville

Responsible Party

Principal Investigator

Henry Greenwell

Professor

University of Louisville

Eligibility Criteria

Inclusion Criteria

•The inclusion criteria were;
•one edentulous site bordered by 2 teeth in the maxilla or mandible from first molar to first molar treatment planned to receive an implant
•at least 18 years of age
•must sign the informed consent -

Exclusion Criteria

•The exclusion criteria included:
•uncontrolled diabetes, immune disease, or any systemic disease that significantly affects the periodontium
•previous head and neck radiation
•oral bisphosphonates for \> 3 years or any IV bisphosphonates
•smoking \> 1/2 pack per day or other tobacco habits that might interfere with soft tissue healing
•requirement for prophylactic antibiotics
•allergies to any medication or material used in the study, or that would adversely affect study procedures
•chemotherapy in the previous 12 months
•psychological problems that would interfere with treatment
•patients unable or unwilling to sign the informed consent