Implant Placement With Simultaneous Gum Grafting

NCT ID: NCT01431144

Last Updated: 2017-02-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2013-06-30

Brief 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.

Conditions

Edentulous

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

connective tissue autograft

Intervention Type: 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

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.

Group Type: EXPERIMENTAL

connective tissue allograft

Intervention Type: PROCEDURE

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

Interventions

connective tissue autograft

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

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

BioHorizons, Inc.

INDUSTRY

Sponsor Role: collaborator

University of Louisville

OTHER

Sponsor Role: lead

Responsible Party

Henry Greenwell

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Henry Greenwell, DMD

Role: PRINCIPAL_INVESTIGATOR

University of Louisville

Locations

Graduate Periodontics Clinic, School of Dentistry, University of Louisville

Louisville, Kentucky, United States

Countries

United States

Other Identifiers

11.0355

Identifier Type: -

Identifier Source: org_study_id