Acellular Dermal Matrix Allograft Versus Free Gingival Graft

Gingivitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03251001
• Other study ID #: BauruSchoolDentistryADM
• Status: Completed
• Phase: N/A
• First received: August 9, 2017
• Last updated: March 8, 2018
• Start date: February 1, 1999
• Est. completion date: December 20, 2017

Study information

• Verified date: March 2018
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 20, 2017
• Est. primary completion date: November 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrophy
• Gingiva Atrophy
• Gingival Recession
• Gingivitis

Intervention

Procedure:
• Control
Free epithelized gingival graft, harvested from palate, was grafted in a site with lack of keratinized gingiva

Device:
• Acellular Dermal Matrix
Acellular Dermal Matrix was grafted in a site with lack of keratinized gingiva, in substitution of an autogenous graft from patient palate

Locations

Country	Name	City	State
Brazil	Bauru School of Dentistry	Bauru	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (2)

Agarwal C, Tarun Kumar AB, Mehta DS. Comparative evaluation of free gingival graft and AlloDerm(®) 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Probing depth	Distance from gingival margin to bottom of gingival sulcus, measured with a periodontal probe. Ideal if < 2mm.	18 years
Secondary	Attachment level	Distance from cemento-enamel junction to bottom of gingival sulcus, measured with a periodontal probe. Ideal if < 2mm.	18 years
Secondary	Recession depth	Distance from cemento-enamel junction to gingival margin, measured with a periodontal probe. Ideal if = 0mm.	18 years