Periodontitis Clinical Trial
Official title:
Clinical and Microbiological Evaluation of Laser Therapy in the Treatment of Periodontal Disease in Stages III and IV
The aim of this clinical trial is to evaluate photodynamic therapy and photobiomodulation in the periodontitis treatment. To evaluate the clinical and microbiological response of conventional periodontal treatment associated with photodynamic therapy and photobiomodulation with red or infrared laser. Participants will receive periodontal treatment carried out with the use 0.005% methylene blue and laser therapy (photodynamic therapy), associated with conventional periodontal treatment, as well as the use of photobiomodulation with red or infrared laser associated with conventional periodontal treatment in participants with periodontitis. So, twenty periodontitis patients will be selected and separated in two groups compared with placebo. Clinical and microbiological parameters will be evaluated at baseline and 3 months after periodontal treatment: plaque Index, bleeding on probe, probing depth, gingival recession and clinical attachment level.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | March 2026 |
Est. primary completion date | February 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: - Adult participants with periodontal disease; - Four or more periodontal sites with PPD=6 mm and CAL=5 mm, non-adjacent; - Generalized periodontitis, with more than 30% of the sites involved (Caton et al., 2018); - Stages III and IV of periodontal disease (Caton et al., 2018); Exclusion Criteria: - Participants with hypersensitivity to the components of the 0.005% methylene blue gel; - Received periodontal treatment in the last six months; - Drugs (alcoholics, use of anti-inflammatories and antibiotics in the last 3 months); Any evidence of systemic modifying factors which may directly interfere with the completion of the work (bias), such as: - Pregnant and breastfeeding women; - Hormone replacement therapy; - Smoking; - Hyperglycemia; - Osteoporosis; - Diagnosed with HIV+ or AIDS. |
Country | Name | City | State |
---|---|---|---|
Brazil | Fluminense Federal University | Nova Friburgo | Rio De Janeiro |
Lead Sponsor | Collaborator |
---|---|
Universidade Federal Fluminense |
Brazil,
Akram Z, Al-Shareef SA, Daood U, Asiri FY, Shah AH, AlQahtani MA, Vohra F, Javed F. Bactericidal Efficacy of Photodynamic Therapy Against Periodontal Pathogens in Periodontal Disease: A Systematic Review. Photomed Laser Surg. 2016 Apr;34(4):137-49. doi: 10.1089/pho.2015.4076. Epub 2016 Mar 16. — View Citation
Akram Z. How effective is adjunctive antimicrobial photodynamic therapy in treating deep periodontal pockets in periodontal disease? A systematic review. J Investig Clin Dent. 2018 Nov;9(4):e12345. doi: 10.1111/jicd.12345. Epub 2018 Jun 4. — View Citation
Ren C, McGrath C, Jin L, Zhang C, Yang Y. The effectiveness of low-level laser therapy as an adjunct to non-surgical periodontal treatment: a meta-analysis. J Periodontal Res. 2017 Feb;52(1):8-20. doi: 10.1111/jre.12361. Epub 2016 Mar 2. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Plaque index (PI) | Plaque index will be expressed in percentage per individual to evaluate the supragingival plaque control. | Baseline and 3 months | |
Primary | Bleeding on probing (BOP) | Bleeding on probing (BOP) will be expressed in percentage per individual to evaluate presence of BOP <20% good results. | Baseline and 3 months | |
Primary | Pocket probing depth (PPD) | Pocket probing depth (PPD) will be evaluated in millimeters. The measure will be performed at six sites per tooth using a periodontal probe. The PPD corresponds to the distance from the gingival margin to the apical portion of the gingival sulcus or periodontal pocket. | Baseline and 3 months | |
Primary | Gingival recession (GR) | Gingival recession (GR) will be measured clinically in millimeters with a periodontal probe as the distance from the cemento-enamel junction to the depth of the free gingival margin. | Baseline and 3 months | |
Primary | Clinical attachment level (CAL) | Clinical attachment level (CAL) will be measured clinically in millimeters with a periodontal probe and corresponds as the distance from the cemento-enamel junction to the base of the periodontal pocket. CAL represents the extension of periodontal support that has been lost around a tooth. | Baseline and 3 months | |
Secondary | Microbiogical analysis | Pooled biofilms from gingival fluid of four sites with PPD with 6 mm or more will be collected to evaluate the presence of periodontal pathogens. The samples will be collected from the selected sites and stored in eppendorfs with PBS 1X in -20oC until the microbiological analyses, that will consist in DNA extraction, electroforesis and qualitative polymerase chain reaction (PCR). | Baseline and 3 months |
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