Evaluation of Root Coverage by Connective Graft and Different Root Conditioning Adjunctive Therapies
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.
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 28, 2018
CompletedFirst Posted
Study publicly available on registry
March 12, 2018
CompletedStudy Start
First participant enrolled
April 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 28, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 28, 2019
CompletedFebruary 27, 2023
February 1, 2023
1.7 years
February 28, 2018
February 24, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Keratinized mucosa width
One year
Probing depth
One year
Clinical attachment level
One year
Dentin hypersensitivity
One year
Study Arms (3)
Control
ACTIVE COMPARATORRoot surface treatment by scaling and root planing
antimicrobial photodynamic therapy
EXPERIMENTALRoot surface treatment by antimicrobial photodynamic therapy
Photobiomodulation
ACTIVE COMPARATORTreatment of the whole surgical site with laser
Interventions
In the procedure of subepithelial connective tissue graft, exposed dental roots will be treated by scaling and root planing only.
In the procedure of subepithelial connective tissue graft, exposed dental roots will be treated by antimicrobial photodynamic therapy with toluidine blue O (10mg/ml)
After the procedure of subepithelial connective tissue graft the whole surgical site will receive red laser application.
Eligibility Criteria
You may qualify if:
- 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%;
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bauru School of Dentistry
Bauru, São Paulo, 17012-901, Brazil
Related Publications (4)
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.
PMID: 26095265BACKGROUNDFernandes-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.
PMID: 25363203BACKGROUNDAnders 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.
PMID: 25844681BACKGROUNDCardoso MV, Sant'Ana ACP, Zangrando MSR, Damante CA. Effects of photobiostimulation and antimicrobial photodynamic therapy associated with gingival grafts for root coverage: three-arm randomized clinical trial. Lasers Med Sci. 2025 Apr 14;40(1):190. doi: 10.1007/s10103-025-04449-0.
PMID: 40227516DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor
Study Record Dates
First Submitted
February 28, 2018
First Posted
March 12, 2018
Study Start
April 1, 2018
Primary Completion
November 28, 2019
Study Completion
November 28, 2019
Last Updated
February 27, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will not share