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

Clinical Efficacy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01902056
• Other study ID #: 12.0330
• Status: Completed
• Phase: N/A
• First received: July 7, 2013
• Last updated: July 15, 2013
• Start date: November 2012
• Est. completion date: June 2013

Study information

• Verified date: July 2013
• Source: University of Louisville
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Clinical Efficacy

Intervention

Procedure:
• One layer allograft
The acellular dermal matrix was placed on the facial surface.
• Two layer allograft
The acellular dermal matrix was placed on the facial surface.

Locations

Country	Name	City	State
United States	Graduate Periodontics Clinic, School of Dentistry, 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	Soft tissue thickness.	Determining the soft tissue thickness using a tissue probe.	4 months	No