Implant Placement and Simultaneous Soft Tissue Grafting With Single or Double Layers of Acellular Dermal Matrix

Not Applicable

Completed

• Conditions: Clinical Efficacy
• Interventions: Procedure: One layer allograft; Procedure: Two layer allograft

• Registration Number: NCT01902056
• Lead Sponsor: University of Louisville

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.

Study Timeline

• Study Start: 2012-11
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2013-07
• Study First Submitted: 2013-07-07
• Study First Submitted QC: 2013-07-15
• Last Update Submitted: 2013-07-15
• Study First Posted: 2013-07-17
• Last Update Posted: 2013-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

The inclusion criteria were;

1. one edentulous site bordered by 2 teeth in the maxilla or mandible from first molar to first molar treatment planned to receive an implant
2. at least 18 years of age
3. must sign the informed consent -

Exclusion Criteria

The exclusion criteria included:

1. uncontrolled diabetes, immune disease, or any systemic disease that significantly affects the periodontium
2. previous head and neck radiation
3. oral bisphosphonates for > 3 years or any IV bisphosphonates
4. smoking > 1/2 pack per day or other tobacco habits that might interfere with soft tissue healing
5. requirement for prophylactic antibiotics
6. allergies to any medication or material used in the study, or that would adversely affect study procedures
7. chemotherapy in the previous 12 months
8. psychological problems that would interfere with treatment
9. patients unable or unwilling to sign the informed consent
10. pregnancy -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
one layer allograft	One layer allograft	One layer allograft as a positive control
Two layer allograft	Two layer allograft	Two layer allograft as the test group.

Primary Outcome Measures

Name	Time	Method
Soft tissue thickness.	4 months	Determining the soft tissue thickness using a tissue probe.

Trial Locations

Locations (1)

Graduate Periodontics Clinic, School of Dentistry, University of Louisville; 🇺🇸 Louisville, Kentucky, United States