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

N/ACompletedNCT01902056

University of Louisville26 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Clinical Efficacy

Interventions

One layer allograftPROCEDURE

The acellular dermal matrix was placed on the facial surface.

Two layer allograftPROCEDURE

The acellular dermal matrix was placed on the facial surface.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 -

Locations (1)

Graduate Periodontics Clinic, School of Dentistry, University of Louisville

Louisville, Kentucky, United States

Outcomes

Primary Outcomes

Soft tissue thickness.

Determining the soft tissue thickness using a tissue probe.

Time frame: 4 months

Data from ClinicalTrials.gov

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