Skip to main content
OpenTrials
Completed

NCT Number: NCT01902056

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Clinical Efficacy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Graduate Periodontics Clinic, School of Dentistry, University of Louisville

Louisville, Kentucky, 40202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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
  • pregnancy -

Treatment and study plan

One layer allograft

Procedure

The acellular dermal matrix was placed on the facial surface.

Other names: One layer of acellular dermal matrix (Alloderm).

Two layer allograft

Procedure

The acellular dermal matrix was placed on the facial surface.

Other names: Two layers of acellular dermal matrix (Alloderm).

Primary outcomes

  1. Soft tissue thickness.

    Time frame: 4 months

    Determining the soft tissue thickness using a tissue probe.

Sponsors and collaborators

Lead sponsor

University of Louisville

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jul 17, 2013
Registry last updated
Jul 17, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.