Acellular Dermal Matrix Allograft Versus Free Gingival Graft
1 other identifier
interventional
25
1 country
1
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 1999
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 1999
CompletedFirst Submitted
Initial submission to the registry
August 9, 2017
CompletedFirst Posted
Study publicly available on registry
August 16, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 20, 2017
CompletedMarch 9, 2018
March 1, 2018
18.8 years
August 9, 2017
March 8, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
keratinized tissue width
Distance from gingival margin to mucogingival junction, measured with a periodontal probe in mm. Ideal if mucosa width is \> 5mm.
18 years
Secondary Outcomes (3)
Probing depth
18 years
Attachment level
18 years
Recession depth
18 years
Study Arms (2)
Control
ACTIVE COMPARATORSites receiving a free gingival graft
Device - Acellular dermal matrix
EXPERIMENTALSites receiving acellular dermal matrix
Interventions
Free epithelized gingival graft, harvested from palate, was grafted in a site with lack of keratinized gingiva
Acellular Dermal Matrix was grafted in a site with lack of keratinized gingiva, in substitution of an autogenous graft from patient palate
Eligibility Criteria
You may qualify if:
- 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%)
You may not qualify if:
- Allergic to penicillin
- Presenting systemic disease that impede surgical procedure
- Smokers
- Pregnancy
- Intake of calcium channel blockers that cause gingival augmentation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bauru School of Dentistry
Bauru, São Paulo, 17012-901, Brazil
Related Publications (2)
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.
PMID: 15974840BACKGROUNDAgarwal 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.
PMID: 26681852BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- All clinical parameters were evaluated by a calibrated examiner (intraclass correlation coefficient = 0.98) blind to test and control groups.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor
Study Record Dates
First Submitted
August 9, 2017
First Posted
August 16, 2017
Study Start
February 1, 1999
Primary Completion
November 30, 2017
Study Completion
December 20, 2017
Last Updated
March 9, 2018
Record last verified: 2018-03