Implant Placement With Simultaneous Gum Grafting

NCT01431144 | Completed Results

• 1 other identifier: 11.0355
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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

Keywords

soft tissue thickness; dental implant; soft tissue recession; implant exposure

Outcome Measures

Primary Outcomes (1)

• Soft Tissue Thickness Over the Implant

  Soft tissue thickness at the facial osseous crest.

  1 year

Study Arms (2)

Connective tissue autograft

ACTIVE COMPARATOR

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

connective tissue allograft

EXPERIMENTAL

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

Interventions

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 autograft

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.

connective tissue allograft

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Louisville: lead
• BioHorizons, Inc.: collaborator

Study Sites (1)

Graduate Periodontics Clinic, School of Dentistry, University of Louisville

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Conditions

Mouth, Edentulous

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Tooth Diseases

Limitations and Caveats

There were no adverse events. There were 2 cases of implant mobility and these was treated as a potential expected complication and handled with routine clinical practice guidelines.

Results Point of Contact

• Title: Henry Greenwell, Principal Investigator
• Organization: University of Louisville

henry.greenwell@louisville.edu

502-852-6928

Study Officials

• Henry Greenwell, DMD

  University of Louisville

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 7, 2011
• First Posted: September 9, 2011
• Study Start: September 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: February 1, 2017
• Results First Posted: September 13, 2013

Record last verified: 2013-07

Locations

US (1)