Clinical Trials Logo

Clinical Trial Summary

The hypothesis to be tested in this study is whether photodynamic therapy (PDT) could favor the decontamination of these areas, as the photosensitizer and light are capable of reaching areas that these instruments have difficulty accessing. In other words, the objective of this study is to evaluate the impact of PDT as an adjuvant treatment to scaling, considering clinical immunoregulatory in patients with gingivitis with the predisposing factor of the use of a fixed orthodontic appliance. A randomized, controlled, double-blind, split-mouth clinical study will include 17 patients. Patients will have their mouth divided into two groups: Control group (n = 17) - Scaling and Root Planing (SRP) + PDT placebo and Experimental group (n = 17) - SRP + PDT. In G2 will be used methylene blue 0.005%, λ = 660nm, 9J (joule) per inflamed site, irradiance = 3.5W / cm (watts/centimeter), radiant exposure = 318J / cm2. In G1 and G2 the scaling will be performed with the aid of the ultrasound. All participants will receive oral hygiene guidance (OHG) after to the end of the study. The clinical periodontal data to be analyzed: plaque index (PI), gingival index (GI) and probing depth (PD) and clinical level of insertion (CLI) by means of a periodontal probe. Crevicular fluid will be collected (from 8 pre-determined sites) for analysis of the IL-6 (interleukin), IL-1β, IL-8, TNF-α (tumor necrosis factor) and IL-10 cytokines, using the ELISA method.


Clinical Trial Description

It is known that the presence of orthodontic brackets predisposes for a change in both the quantity and quality of the biofilm, due to the challenge of brushing adequately. The sites are difficult to access with a toothbrush and periodontal curette, worsening inflammation. In addition, gingival growth is frequently associated with poor hygiene. The hypothesis to be tested in this study is whether photodynamic therapy (PDT) could favor the decontamination of these areas, as the photosensitizer and light are capable of reaching areas that these instruments have difficulty accessing. In other words, the objective of this study is to evaluate the impact of PDT as an adjuvant treatment to scaling, considering clinical and immunoregulatory parameters in patients with gingivitis with the predisposing factor of the use of a fixed orthodontic appliance. A randomized, controlled, double-blind, split-mouth clinical study will include 17 patients, both genders, having used the fixed appliance for more than 12 months, with gingivitis present. Patients will have their mouth divided into two groups: Control group (n = 17) - Scaling and Root Planing (SRP) + PDT placebo and Experimental group (n = 17) - SRP + PDT. In G2 methylene blue 0.005%, λ = 660nm, 9J (joule) per inflamed site, irradiance = 3.5W/ cm, radiant exposure = 318J/ cm2. In G1 and G2 the scaling will be performed with the aid of the ultrasound. All participants will receive oral hygiene guidance (OHG) after to the end of the study. The clinical periodontal data to be analyzed: plaque index (PI), gingival index (GI) and probing depth (PD) and clinical level of insertion (CLI) by means of a periodontal probe. Crevicular fluid will be collected (from 8 pre-determined sites) for analysis of the IL-6, IL-1β, IL-8, TNF-α and IL-10 cyttokines, using the ELISA method. All analysis will be realized using the baseline (T0) and (T1) 30 days after treatment. If sample distribution is normal, the Student T-test will be used to compare the measurement of continuous and dependent variables. If it is not normal, the Mann-Whitney test will be used. The data will be presented in terms of ± PD and the value of p will be defined as 0.05. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04037709
Study type Interventional
Source University of Nove de Julho
Contact
Status Completed
Phase N/A
Start date November 9, 2020
Completion date March 15, 2022

See also
  Status Clinical Trial Phase
Not yet recruiting NCT05568290 - Interleukin-38 Levels in Individuals With Periodontitis
Completed NCT04402996 - Meteorin-like Levels in Individuals With Periodontitis
Not yet recruiting NCT06016023 - Evaluation of Macrophage Inflammatory Protein-1α as a Periodontal Disease Biomarker
Not yet recruiting NCT05497895 - The Assessment of Clinical Efficacy of Topical Application of 5% Thymoquinone Gel for Gingivitis Patients Early Phase 1
Completed NCT02633345 - Effects on Tablets Containing Probiotic Candidate Strains N/A
Completed NCT02884817 - Essential Oil+ELA, Plaque and Gingivitis Phase 4
Completed NCT02552589 - Effect of Toothpaste on the Reduction of Plaque and Inflammation N/A
Completed NCT02980497 - Antiplaque/Antigingivitis Efficacy of Essential Oil Mouthrinses in Six-Month Study N/A
Completed NCT02235532 - Effects of Aloe Vera Toothpaste on Periodontal Parameters N/A
Completed NCT02515929 - Prospective Double-Blind Randomized Controlled Clinical Trial in the Gingivitis Prevention With OPCs Phase 4
Unknown status NCT01956656 - Efficacy Of Lotus Leaves In Management Of Plaque Induced Gingivitis N/A
Completed NCT01941797 - Experimental Peri-implant Mucositis in Humans N/A
Completed NCT02508987 - Obesity and Oxidative Stress in Patients With Different Periodontal Status N/A
Completed NCT01593540 - Clinical Examination of Metal Free Interdental Brushes Phase 4
Unknown status NCT01197105 - Evaluation Study of a Mouthwash Based on Schinus Terebinthifolius to Treat Gingivitis in Children Phase 1/Phase 2
Completed NCT01236963 - Essential Oils Mouth Rinse and Dental Floss: Efficacy on Interproximal Gingivitis and Dental Plaque Accumulation N/A
Completed NCT02102295 - Effects of Antioxidant Dentifrice on Gingivitis Phase 3
Completed NCT06140784 - A Clinical Study to Assess the Gingivitis and Plaque Effects of Various Dentifrices N/A
Completed NCT02937636 - To Investigate the Gingivitis Efficacy of a Stannous Fluoride Dentifrice in a Chinese Population N/A
Completed NCT06212908 - Assessment of Periodontal Therapy and Biofilm Management in Breast Cancer N/A