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

Primary Purpose

Gingival Recession, Gingival Recession, Generalized

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Control
antimicrobial photodynamic therapy
Photobiomodulation
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingival Recession

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Bauru School of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Active Comparator

Arm Label

Control

antimicrobial photodynamic therapy

Photobiomodulation

Arm Description

Root surface treatment by scaling and root planing

Root surface treatment by antimicrobial photodynamic therapy

Treatment of the whole surgical site with laser

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
February 28, 2018
Last Updated
February 24, 2023
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT03462368
Brief Title
Evaluation of Root Coverage by Connective Graft and Different Root Conditioning Adjunctive Therapies
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.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
November 28, 2019 (Actual)
Study Completion Date
November 28, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recession, Gingival Recession, Generalized

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Active Comparator
Arm Description
Root surface treatment by scaling and root planing
Arm Title
antimicrobial photodynamic therapy
Arm Type
Experimental
Arm Description
Root surface treatment by antimicrobial photodynamic therapy
Arm Title
Photobiomodulation
Arm Type
Active Comparator
Arm Description
Treatment of the whole surgical site with laser
Intervention Type
Procedure
Intervention Name(s)
Control
Other Intervention Name(s)
Scaling and root planing only
Intervention Description
In the procedure of subepithelial connective tissue graft, exposed dental roots will be treated by scaling and root planing only.
Intervention Type
Procedure
Intervention Name(s)
antimicrobial photodynamic therapy
Intervention Description
In the procedure of subepithelial connective tissue graft, exposed dental roots will be treated by antimicrobial photodynamic therapy with toluidine blue O (10mg/ml)
Intervention Type
Procedure
Intervention Name(s)
Photobiomodulation
Other Intervention Name(s)
Low level laser therapy
Intervention Description
After the procedure of subepithelial connective tissue graft the whole surgical site will receive red laser application.
Primary Outcome Measure Information:
Title
Total root coverage
Description
Total root coverage measured with a periodontal probe in millimeters. Ideal if the distance from cemento-enamel junction to gingival margin = 0 mm
Time Frame
One year
Secondary Outcome Measure Information:
Title
Keratinized mucosa width
Description
Keratinized mucosa width is measured with a periodontal probe in mm, from gingival margin to mucogingival junction. Ideal if keratinized mucosa width > 5mm
Time Frame
One year
Title
Probing depth
Description
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.
Time Frame
One year
Title
Clinical attachment level
Description
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.
Time Frame
One year
Title
Dentin hypersensitivity
Description
Dentin hypersensitivity measured by applying an air jet on teeth and patient fills up a visual analogue scale. Ideal if = 0.
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Bauru School of Dentistry
City
Bauru
State/Province
Sao Paulo
ZIP/Postal Code
17012-901
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26095265
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.
Results Reference
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PubMed Identifier
25363203
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.
Results Reference
background
PubMed Identifier
25844681
Citation
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.
Results Reference
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Evaluation of Root Coverage by Connective Graft and Different Root Conditioning Adjunctive Therapies

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