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OpenTrials
Completed

NCT Number: NCT01431144

Implant Placement With Simultaneous Gum Grafting

This study is a comparison of implant placed and simultaneously grafted with either autogenous connective tissue or a connective tissue allograft. The objective is to determine the change in soft tissue thickness and determine if a better result is obtained with the autograft or the allograft. The hypothesis is that there will be no difference in soft tissue thickness over the implant between the autograft and the allograft technique.

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Key information

Conditions

Edentulous Mouth Diseases Mouth, Edentulous Stomatognathic Diseases Tooth Diseases

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

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • One edentulous site bordered by 2 teeth needing a dental implant

Exclusion criteria

  • Systemic diseases that affect the periodontium
  • Previous head and neck radiation
  • Smoking more that 1/2 pack per day
  • Requires prophylactic antibiotics
  • Allergy to meds used in study
  • Previous chemotherapy
  • Pregnancy

Treatment and study plan

connective tissue autograft

Procedure

A connective tissue autograft is harvested from the palate and grafted at the site of implant placement on the facial surface.

connective tissue allograft

Procedure

An acellular dermal matrix allograft (Alloderm, BioHorizons, Inc, Birmingham, AL, USA) is grafted at the site of implant placement on the facial surface.

Primary outcomes

  1. Soft Tissue Thickness Over the Implant

    Time frame: 1 year

    Soft tissue thickness at the facial osseous crest.

Sponsors and collaborators

Lead sponsor

University of Louisville

Other

Collaborators

  • BioHorizons, Inc.

Registry information

Official study title

The Effect of Implant Placement and Simultaneous Soft Tissue Augmentation in the Esthetic Zone Using Either Connective Tissue Autograft or Acellular Dermal Matrix Allograft on Peri-implant Hard and Soft Tissue Healing

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Sep 9, 2011
Registry last updated
Feb 1, 2017

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.

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