Implant Placement With Simultaneous Gum Grafting

December 6, 2016 updated by: Henry Greenwell, University of Louisville

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Graduate Periodontics Clinic, School of Dentistry, University of Louisville

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Connective tissue autograft
A connective tissue autograft harvested from the palate was grafted onto the facial of a simultaneously placed dental implant and soft tissue thickness was measured at baseline and Time 4.
Procedure: connective tissue autograft
A connective tissue autograft is harvested from the palate and grafted at the site of implant placement on the facial surface.
Experimental: connective tissue allograft
An acellular dermal matrix allograft was grafted on the facial surface of a simultaneously placed dental implant and soft tissue thickness was measured at baseline and Time 4.
Procedure: connective tissue allograft
An acellular dermal matrix allograft (Alloderm, BioHorizons, Inc, Birmingham, AL, USA) is grafted at the site of implant placement on the facial surface.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Soft Tissue Thickness Over the Implant
Time Frame: 1 year
Soft tissue thickness at the facial osseous crest.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Louisville

Collaborators

BioHorizons, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

September 7, 2011

First Submitted That Met QC Criteria

September 8, 2011

First Posted (Estimate)

September 9, 2011

Study Record Updates

Last Update Posted (Estimate)

February 1, 2017

Last Update Submitted That Met QC Criteria

December 6, 2016

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11.0355

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Edentulous

Clinical Trials on connective tissue autograft

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hungary

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe