Evaluation of Root Coverage by Connective Graft and Different Root Conditioning Methods

Gingival Recession Clinical Trial

Official title:

Evaluation of Root Coverage by Subepithelial Connective Graft Associated to Root Conditioning by Citric Acid Plus Tetracycline and Antimicrobial Photodynamic Therapy: A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03095378
• Other study ID #: BauruSchoolDentistryPDT
• Status: Completed
• Phase: N/A
• First received: March 23, 2017
• Last updated: March 23, 2017
• Start date: March 10, 2014
• Est. completion date: March 10, 2017

Study information

• Verified date: March 2017
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study was to evaluate the effect of two root-conditioning agents used in conjunction with subepithelial connective graft technique on root coverage outcomes. One is citric acid plus tetracycline and the other is antimicrobial photodynamic therapy.

Description:

Citric acid plus tetracycline has properties of root surface decontamination, surface demineralization and exposure of collagen fibers.

Antimicrobial photodynamic therapy has been widely used in Periodontics to obtain reduction of periodontopathogenic bacteria with absence of systemic side effects and minimal bacterial resistance. Also, it has properties of root demineralization and exposure of collagen fibers. These properties may enhance root coverage in procedures of subepithelial connective graft.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: March 10, 2017
• Est. primary completion date: February 10, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

Inclusion Criteria:

• Gingival recession - Miller's class I or II (2 to 5 mm of height) at least in one tooth

• Indication of root coverage by dentin hypersensitivity or esthetic

Exclusion Criteria:

• Smokers

• Pregnancy

• Systemic medication use that could impair wound healing or surgery procedure

• Systemic diseases as diabetes, uncontrolled hypertension, coagulation diseases, kidney diseases.

Related Conditions & MeSH terms

• Gingival Recession

Intervention

Procedure:
• Control
Periodontal plastic surgery aiming root coverage by palatal connective tissue graft. Root treatment with scaling and root planing
• citric acid plus tetracycline
Periodontal plastic surgery aiming root coverage by palatal connective tissue graft. Root treatment with citric acid plus tetracycline
• antimicrobial photodynamic therapy
Periodontal plastic surgery aiming root coverage by palatal connective tissue graft. Root treatment with antimicrobial photodynamic therapy

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)

Damante CA, Ducati P, Ferreira R, Salmeron S, Zangrando MS, de Rezende ML, Sant'Ana AC, Greghi SL, Magalhães AC. In vitro evaluation of adhesion/proliferation of human gingival fibroblasts on demineralized root surfaces by toluidine blue O in antimicrobial photodynamic therapy. Photodiagnosis Photodyn Ther. 2016 Mar;13:303-7. doi: 10.1016/j.pdpdt.2015.08.009. — View Citation

Karam PS, Sant'Ana AC, de Rezende ML, Greghi SL, Damante CA, Zangrando MS. Root surface modifiers and subepithelial connective tissue graft for treatment of gingival recessions: a systematic review. J Periodontal Res. 2016 Apr;51(2):175-85. doi: 10.1111/jre.12296. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total root coverage measured with a periodontal probe in mm	Distance from cemento-enamel junction to gingival margin = 0 mm	one year
Secondary	Keratinized mucosa width measured with a periodontal probe in mm	Ideal if keratinized mucosa width > 5mm	one year
Secondary	Dentin hypersensitivity measured by applying an air jet on teeth and patient fills up a visual analogue scale	Ideal if scale = 0	one year