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

Not Applicable

Completed

• Conditions: Gingival Recession; Gingival Recession, Generalized
• Interventions: Procedure: antimicrobial photodynamic therapy; Procedure: Control; Procedure: Photobiomodulation

• Registration Number: NCT03462368
• Lead Sponsor: University of Sao Paulo

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2018-02-28
• Study First Submitted QC: 2018-03-08
• Study First Posted: 2018-03-12
• Study Start: 2018-04-01
• Primary Completion: 2019-11-28
• Study Completion: 2019-11-28
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-24
• Last Update Posted: 2023-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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%;

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
antimicrobial photodynamic therapy	antimicrobial photodynamic therapy	Root surface treatment by antimicrobial photodynamic therapy
Control	Control	Root surface treatment by scaling and root planing
Photobiomodulation	Photobiomodulation	Treatment of the whole surgical site with laser

Primary Outcome Measures

Name	Time	Method
Total root coverage	One year	Total root coverage measured with a periodontal probe in millimeters. Ideal if the distance from cemento-enamel junction to gingival margin = 0 mm

Secondary Outcome Measures

Name	Time	Method
Probing depth	One year	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.
Clinical attachment level	One year	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.
Dentin hypersensitivity	One year	Dentin hypersensitivity measured by applying an air jet on teeth and patient fills up a visual analogue scale. Ideal if = 0.
Keratinized mucosa width	One year	Keratinized mucosa width is measured with a periodontal probe in mm, from gingival margin to mucogingival junction. Ideal if keratinized mucosa width \> 5mm

Trial Locations

Locations (1)

Bauru School of Dentistry; 🇧🇷 Bauru, Sao Paulo, Brazil