Implant Placement With Simultaneous Gum Grafting

This study has been completed.
Sponsor:
Collaborator:
BioHorizons, Inc.
Information provided by (Responsible Party):
Henry Greenwell, University of Louisville
ClinicalTrials.gov Identifier:
NCT01431144
First received: September 7, 2011
Last updated: July 7, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Edentulous
Procedure: connective tissue autograft
Procedure: connective tissue allograft

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

Further study details as provided by University of Louisville:

Primary Outcome Measures:
  • Soft Tissue Thickness Over the Implant [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Soft tissue thickness at the facial osseous crest.


Enrollment: 27
Study Start Date: September 2011
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01431144

Locations
United States, Kentucky
Graduate Periodontics Clinic, School of Dentistry, University of Louisville
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
University of Louisville
BioHorizons, Inc.
Investigators
Principal Investigator: Henry Greenwell, DMD University of Louisville
  More Information

No publications provided

Responsible Party: Henry Greenwell, Principal Investigator, University of Louisville
ClinicalTrials.gov Identifier: NCT01431144     History of Changes
Other Study ID Numbers: 11.0355
Study First Received: September 7, 2011
Results First Received: July 7, 2013
Last Updated: July 7, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Louisville:
soft tissue thickness
dental implant
soft tissue recession
implant exposure

Additional relevant MeSH terms:
Mouth, Edentulous
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases

ClinicalTrials.gov processed this record on July 31, 2014