An interventional study of connective tissue autograft and connective tissue allograft in Edentulous, sponsored by University of Louisville. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-02-01.
Sponsored by University of Louisville · Not applicable, Interventional, and Treatment
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.
244 studies on the registry are indexed under Mouth, Edentulous; 37 are open to participants now.
This study's enrollment of 27 is close to the median of 30 across 187 interventional studies indexed under Mouth, Edentulous.
Browse Mouth, Edentulous studies →University of Louisville is the lead sponsor of 284 studies on the registry; 53 are open to participants now.
Of its 20 completed or terminated interventional studies of FDA-regulated products, 7 (35%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
A connective tissue autograft is harvested from the palate and grafted at the site of implant placement on the facial surface.
An acellular dermal matrix allograft (Alloderm, BioHorizons, Inc, Birmingham, AL, USA) is grafted at the site of implant placement on the facial surface.
Soft Tissue Thickness Over the Implant
Soft tissue thickness at the facial osseous crest.
Time frame: 1 year
27 patients were entered, 13 for the test allograft group and 14 for the positive control connective tissue autograft group
| Milestone | Connective Tissue Allograft | Connective Tissue Autograft |
|---|---|---|
| Started | 13 | 14 |
| Completed | 11 | 14 |
| Not completed | 2 | 0 |
| Withdrew: Implant mobility and removal | 2 | 0 |
Soft tissue thickness at the facial osseous crest.
| mm | Connective Tissue Allograft | Connective Tissue Autograft |
|---|---|---|
| Soft Tissue Thickness Over the Implant | 0.6 ± 1.2 | 0.4 ± 0.7 |
Collected over Baseline to final, no adverse events. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Connective Tissue Allograft | — | 0/13 (0%) | 0/13 (0%) |
| Connective Tissue Autograft | — | 0/14 (0%) | 0/14 (0%) |
| Age, Categorical(Participants) | Connective Tissue Allograft | Connective Tissue Autograft | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 10 | 9 | 19 |
| >=65 years | 3 | 5 | 8 |
| Age, Continuous(years) | Connective Tissue Allograft | Connective Tissue Autograft | Total |
|---|---|---|---|
| Mean | 46 ± 21 | 57 ± 10 | 52 ± 16 |
| Gender(Participants) | Connective Tissue Allograft | Connective Tissue Autograft | Total |
|---|---|---|---|
| Female | 7 | 9 | 16 |
| Male | 6 | 5 | 11 |
| Region of Enrollment(participants) | Connective Tissue Allograft | Connective Tissue Autograft | Total |
|---|---|---|---|
| United States | 13 | 14 | 27 |
This study is completed, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.
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University of Louisville