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Acellular Dermal Matrix Allograft Versus Free Gingival Graft

Acellular Dermal Matrix Allograft Versus Free Gingival Graft: a Histological Evaluation and Split-mouth Randomized Clinical Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03251001
Enrollment
25
Registered
2017-08-16
Start date
1999-02-01
Completion date
2017-12-20
Last updated
2018-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gingiva Atrophy, Gingivitis

Keywords

gingiva, keratinized mucosa, gingival graft

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)

Interventions

PROCEDUREControl

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

Sponsors

University of Sao Paulo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

All clinical parameters were evaluated by a calibrated examiner (intraclass correlation coefficient = 0.98) blind to test and control groups.

Intervention model description

Split-mouth design. One side of mouth was test group, other side was control group.

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
keratinized tissue width18 yearsDistance from gingival margin to mucogingival junction, measured with a periodontal probe in mm. Ideal if mucosa width is \> 5mm.

Secondary

MeasureTime frameDescription
Probing depth18 yearsDistance from gingival margin to bottom of gingival sulcus, measured with a periodontal probe. Ideal if \< 2mm.
Attachment level18 yearsDistance from cemento-enamel junction to bottom of gingival sulcus, measured with a periodontal probe. Ideal if \< 2mm.
Recession depth18 yearsDistance from cemento-enamel junction to gingival margin, measured with a periodontal probe. Ideal if = 0mm.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026