Implant Placement With Simultaneous Gum Grafting

Edentulous Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01431144
• Other study ID #: 11.0355
• Status: Completed
• Phase: N/A
• First received: September 7, 2011
• Last updated: July 7, 2013
• Start date: September 2011
• Est. completion date: June 2013

Study information

• Verified date: July 2013
• Source: University of Louisville
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Edentulous

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Graduate Periodontics Clinic, School of Dentistry, University of Louisville	Louisville	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
University of Louisville	BioHorizons, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Soft Tissue Thickness Over the Implant	Soft tissue thickness at the facial osseous crest.	1 year	No