Edentulous
Conditions
Keywords
soft tissue thickness, dental implant, soft tissue recession, implant exposure
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.
Interventions
PROCEDUREconnective tissue autograft
A connective tissue autograft is harvested from the palate and grafted at the site of implant placement on the facial surface.
PROCEDUREconnective 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.
Sponsors
BioHorizons, Inc.
University of Louisville
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Soft Tissue Thickness Over the Implant | 1 year | Soft tissue thickness at the facial osseous crest. |
Countries
United States
Participant flow
Recruitment details
27 patients were entered, 13 for the test allograft group and 14 for the positive control connective tissue autograft group
Pre-assignment details
There were no exclusions prior to assignment or treatment.
Participants by arm
| Arm | Count |
|---|---|
| Connective Tissue Allograft A connective tissue allograft was placed simultaneously with dental implant placement and soft tissue thickness was measured at baseline and Time 4. | 13 |
| Connective Tissue Autograft A connective tissue autograft was placed simultaneously with dental implant placement and soft tissue thickness was measured at baseline and Time 4. | 14 |
| Total | 27 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Implant mobility and removal | 2 | 0 |
Baseline characteristics
| Characteristic | Connective Tissue Autograft | Connective Tissue Allograft | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 3 Participants | 8 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 10 Participants | 19 Participants |
| Age, Continuous | 57 years STANDARD_DEVIATION 10 | 46 years STANDARD_DEVIATION 21 | 52 years STANDARD_DEVIATION 16 |
| Gender Female | 9 Participants | 7 Participants | 16 Participants |
| Gender Male | 5 Participants | 6 Participants | 11 Participants |
| Region of Enrollment United States | 14 participants | 13 participants | 27 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 13 | 0 / 14 |
| serious Total, serious adverse events | 0 / 13 | 0 / 14 |
Outcome results
Primary
Soft Tissue Thickness Over the Implant
Soft tissue thickness at the facial osseous crest.
Time frame: 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Connective Tissue Allograft | Soft Tissue Thickness Over the Implant | 0.6 mm | Standard Deviation 1.2 |
| Connective Tissue Autograft | Soft Tissue Thickness Over the Implant | 0.4 mm | Standard Deviation 0.7 |