Back to resultsAcellular Dermal Matrix Allograft Versus Free Gingival Graft
Primary Purpose
Gingiva Atrophy, Gingivitis
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Control
Acellular Dermal Matrix
Sponsored by
About this trial
This is an interventional treatment trial for Gingiva Atrophy focused on measuring gingiva, keratinized mucosa, gingival graft
Eligibility Criteria
Inclusion Criteria:
- absence or deficiency of keratinized tissue (< 1mm) in two homologous contralateral sites of inferior premolars
- Miller Class I or II gingival recession
- Absence of radiographic bone loss
- Vital tooth or with adequate endodontic treatment
- Root surfaces without caries
- Good oral hygiene (plaque index < 20%)
Exclusion Criteria:
- Allergic to penicillin
- Presenting systemic disease that impede surgical procedure
- Smokers
- Pregnancy
- Intake of calcium channel blockers that cause gingival augmentation
Sites / Locations
- Bauru School of Dentistry
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control
Device - Acellular dermal matrix
Arm Description
Sites receiving a free gingival graft
Sites receiving acellular dermal matrix
Outcomes
Primary Outcome Measures
keratinized tissue width
Distance from gingival margin to mucogingival junction, measured with a periodontal probe in mm. Ideal if mucosa width is > 5mm.
Secondary Outcome Measures
Probing depth
Distance from gingival margin to bottom of gingival sulcus, measured with a periodontal probe. Ideal if < 2mm.
Attachment level
Distance from cemento-enamel junction to bottom of gingival sulcus, measured with a periodontal probe. Ideal if < 2mm.
Recession depth
Distance from cemento-enamel junction to gingival margin, measured with a periodontal probe. Ideal if = 0mm.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03251001
Brief Title
Acellular Dermal Matrix Allograft Versus Free Gingival Graft
Official Title
Acellular Dermal Matrix Allograft Versus Free Gingival Graft: a Histological Evaluation and Split-mouth Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
February 1, 1999 (Actual)
Primary Completion Date
November 30, 2017 (Actual)
Study Completion Date
December 20, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The present split-mouth controlled randomized clinical trial aimed to evaluate clinical and histological results of acellular dermal matrix allograft (ADM) compared to autogenous free gingival graft (FGG)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingiva Atrophy, Gingivitis
Keywords
gingiva, keratinized mucosa, gingival graft
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Split-mouth design. One side of mouth was test group, other side was control group.
Masking
Outcomes Assessor
Masking Description
All clinical parameters were evaluated by a calibrated examiner (intraclass correlation coefficient = 0.98) blind to test and control groups.
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Sites receiving a free gingival graft
Arm Title
Device - Acellular dermal matrix
Arm Type
Experimental
Arm Description
Sites receiving acellular dermal matrix
Intervention Type
Procedure
Intervention Name(s)
Control
Intervention Description
Free epithelized gingival graft, harvested from palate, was grafted in a site with lack of keratinized gingiva
Intervention Type
Device
Intervention Name(s)
Acellular Dermal Matrix
Other Intervention Name(s)
allograft
Intervention Description
Acellular Dermal Matrix was grafted in a site with lack of keratinized gingiva, in substitution of an autogenous graft from patient palate
Primary Outcome Measure Information:
Title
keratinized tissue width
Description
Distance from gingival margin to mucogingival junction, measured with a periodontal probe in mm. Ideal if mucosa width is > 5mm.
Time Frame
18 years
Secondary Outcome Measure Information:
Title
Probing depth
Description
Distance from gingival margin to bottom of gingival sulcus, measured with a periodontal probe. Ideal if < 2mm.
Time Frame
18 years
Title
Attachment level
Description
Distance from cemento-enamel junction to bottom of gingival sulcus, measured with a periodontal probe. Ideal if < 2mm.
Time Frame
18 years
Title
Recession depth
Description
Distance from cemento-enamel junction to gingival margin, measured with a periodontal probe. Ideal if = 0mm.
Time Frame
18 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
absence or deficiency of keratinized tissue (< 1mm) in two homologous contralateral sites of inferior premolars
Miller Class I or II gingival recession
Absence of radiographic bone loss
Vital tooth or with adequate endodontic treatment
Root surfaces without caries
Good oral hygiene (plaque index < 20%)
Exclusion Criteria:
Allergic to penicillin
Presenting systemic disease that impede surgical procedure
Smokers
Pregnancy
Intake of calcium channel blockers that cause gingival augmentation
Facility Information:
Facility Name
Bauru School of Dentistry
City
Bauru
State/Province
Sao Paulo
ZIP/Postal Code
17012-901
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
15974840
Citation
Cummings LC, Kaldahl WB, Allen EP. Histologic evaluation of autogenous connective tissue and acellular dermal matrix grafts in humans. J Periodontol. 2005 Feb;76(2):178-86. doi: 10.1902/jop.2005.76.2.178.
Results Reference
background
PubMed Identifier
26681852
Citation
Agarwal C, Tarun Kumar AB, Mehta DS. Comparative evaluation of free gingival graft and AlloDerm((R)) in enhancing the width of attached gingival: A clinical study. Contemp Clin Dent. 2015 Oct-Dec;6(4):483-8. doi: 10.4103/0976-237X.169838.
Results Reference
background
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Acellular Dermal Matrix Allograft Versus Free Gingival Graft
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