Back to resultsImplant Placement With Simultaneous Gum Grafting
Primary Purpose
Edentulous
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
connective tissue autograft
connective tissue allograft
Sponsored by
About this trial
This is an interventional treatment trial for Edentulous focused on measuring soft tissue thickness, dental implant, soft tissue recession, implant exposure
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
Sites / Locations
- Graduate Periodontics Clinic, School of Dentistry, University of Louisville
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Connective tissue autograft
connective tissue allograft
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Soft Tissue Thickness Over the Implant
Soft tissue thickness at the facial osseous crest.
Secondary Outcome Measures
Full Information
NCT ID
NCT01431144
First Posted
September 7, 2011
Last Updated
December 6, 2016
Sponsor
University of Louisville
Collaborators
BioHorizons, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01431144
Brief Title
Implant Placement With Simultaneous Gum Grafting
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Louisville
Collaborators
BioHorizons, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Edentulous
Keywords
soft tissue thickness, dental implant, soft tissue recession, implant exposure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Connective tissue autograft
Arm Type
Active Comparator
Arm Description
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.
Arm Title
connective tissue allograft
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
connective tissue autograft
Intervention Description
A connective tissue autograft is harvested from the palate and grafted at the site of implant placement on the facial surface.
Intervention Type
Procedure
Intervention Name(s)
connective tissue allograft
Intervention Description
An acellular dermal matrix allograft (Alloderm, BioHorizons, Inc, Birmingham, AL, USA) is grafted at the site of implant placement on the facial surface.
Primary Outcome Measure Information:
Title
Soft Tissue Thickness Over the Implant
Description
Soft tissue thickness at the facial osseous crest.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henry Greenwell, DMD
Organizational Affiliation
University of Louisville
Official's Role
Principal Investigator
Facility Information:
Facility Name
Graduate Periodontics Clinic, School of Dentistry, University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Implant Placement With Simultaneous Gum Grafting
We'll reach out to this number within 24 hrs