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Completed

NCT Number: NCT03462368

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

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.

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Key information

Conditions

Gingival Recession Gingival Diseases Gingival Recession, Generalized Mouth Diseases Periodontal Atrophy Periodontal Diseases Stomatognathic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bauru School of Dentistry

Bauru, São Paulo, 17012-901, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Control

Procedure

In the procedure of subepithelial connective tissue graft, exposed dental roots will be treated by scaling and root planing only.

Other names: Scaling and root planing only

antimicrobial photodynamic therapy

Procedure

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

Procedure

After the procedure of subepithelial connective tissue graft the whole surgical site will receive red laser application.

Other names: Low level laser therapy

Primary outcomes

  1. Total root coverage

    Time frame: 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 outcomes

  1. Keratinized mucosa width

    Time frame: 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

  2. Probing depth

    Time frame: 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.

  3. Clinical attachment level

    Time frame: 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.

  4. Dentin hypersensitivity

    Time frame: One year

    Dentin hypersensitivity measured by applying an air jet on teeth and patient fills up a visual analogue scale. Ideal if = 0.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study 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.

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 12, 2018
Registry last updated
Feb 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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