Evaluation of Root Coverage by Connective Graft and Different Root Conditioning Adjunctive Therapies

Gingival Recession Clinical Trial

Official title:

Effects of Photobiomodulation and Antimicrobial Photodynamic Therapy Associated With Subepithelial Connective Tissue Graft on the Root Coverage of Multiple Gingival Recessions: A Randomized Controlled Clinical Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03462368
• Other study ID #: FOBaPDTrecession
• Status: Completed
• Phase: N/A
• Start date: April 1, 2018
• Est. completion date: November 28, 2019

Study information

• Verified date: February 2023
• 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 different treatment agents used in conjunction with subepithelial connective graft technique on root coverage outcomes in multiple recession defects. Half of patients will receive root treatment with antimicrobial photodynamic therapy and the other half will receive photobiomodulation therapy by laser on surgery site.

Description:

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. Laser photobiomodulation has the potential to increase healing and repair, this can generate gains in the root coverage and dental hypersensitivity.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 28, 2019
• Est. primary completion date: November 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Multiple Gingival recession - two or more Miller's class I or II (2 to 5 mm of height)

• Indication of root coverage by dentin hypersensitivity or esthetic.

• Minimum palate thickness (1,5mm)

• Visible Enamel cement junction (JCE) on the teeth to be treated and pulp vitality

• Patients without signs of periodontal disease activity and with plaque index and bleeding on probing throughout =20%;

Exclusion Criteria:

• Use of drugs that affect periodontal tissues (eg: anticonvulsants, calcium channel blockers, cyclosporine, bisphosphonates, hormone-based contraceptives, steroids)

• Smokers

• Pregnancy

• Diabetics

• History of head and neck radiotherapy

• Teeth with mobility

• Malpositioned teeth

• History of periodontal surgery at the area on the last 12 months

• Patients with orthodontic therapy in progression

Related Conditions & MeSH terms

• Gingival Recession
• Gingival Recession, Generalized

Intervention

Procedure:
• Control
In the procedure of subepithelial connective tissue graft, exposed dental roots will be treated by scaling and root planing only.
• antimicrobial photodynamic therapy
In the procedure of subepithelial connective tissue graft, exposed dental roots will be treated by antimicrobial photodynamic therapy with toluidine blue O (10mg/ml)
• Photobiomodulation
After the procedure of subepithelial connective tissue graft the whole surgical site will receive red laser application.

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 (3)

Anders JJ, Lanzafame RJ, Arany PR. Low-level light/laser therapy versus photobiomodulation therapy. Photomed Laser Surg. 2015 Apr;33(4):183-4. doi: 10.1089/pho.2015.9848. No abstract available. — View Citation

Fernandes-Dias SB, de Marco AC, Santamaria M Jr, Kerbauy WD, Jardini MA, Santamaria MP. Connective tissue graft associated or not with low laser therapy to treat gingival recession: randomized clinical trial. J Clin Periodontol. 2015 Jan;42(1):54-61. doi: 10.1111/jcpe.12328. Epub 2014 Dec 17. — 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. Epub 2015 Jun 11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total root coverage	Total root coverage measured with a periodontal probe in millimeters. Ideal if the distance from cemento-enamel junction to gingival margin = 0 mm	One year
Secondary	Keratinized mucosa width	Keratinized mucosa width is measured with a periodontal probe in mm, from gingival margin to mucogingival junction. Ideal if keratinized mucosa width > 5mm	One year
Secondary	Probing depth	Probing depth measured with a periodontal probe in millimeters. The distance from gingival margin and the apical point of gingival pocket or sulcus. Ideal if <2mm.	One year
Secondary	Clinical attachment level	Clinical attachment level measured with a periodontal probe in millimeters. The distance from cemento-enamel junction and the apical point of gingival pocket or sulcus. Ideal if <2mm.	One year
Secondary	Dentin hypersensitivity	Dentin hypersensitivity measured by applying an air jet on teeth and patient fills up a visual analogue scale. Ideal if = 0.	One year