An interventional study of scaling and root planing (SRP) + PDT placebo and scaling and root planing (SRP) + PDT in Gingivitis, Orthodontic Appliance Complication and Photodynamic Therapy, sponsored by University of Nove de Julho. Completed at 1 site in Brazil. Open to participants aged 10 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-11.
Sponsored by University of Nove de Julho · Not applicable, Interventional, and Treatment
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.
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.
590 studies on the registry are indexed under Gingivitis; 104 are open to participants now.
This study's enrollment of 20 is below the median of 64 across 478 interventional studies indexed under Gingivitis.
Browse Gingivitis studies →University of Nove de Julho is the lead sponsor of 239 studies on the registry; 51 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 1 (13%) have results posted.
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Exclusion Criteria:
17 patients will receive periodontal treatment (scaling and root planing - SRP) with the ultrasound. The SRP will be done in one session. SRP will be performed by only one experienced researcher. Periodontal reassessment will be performed after 30 days. The PDT placebo wil be done using an agent with the same vehicle as that of the methylene blue to mimic irrigation with the photosensitizer; the laser will be switched off at the time of application.
Procedure: scaling and root planing (SRP) + PDT placebo
17 patients will receive the same scaling and root planing treatment that placebo group. However the PDT will be done only on one side of the mouth using methylene blue 0.005% - Chimiolux 5, DMC - purified water and methylene blue.The red laser diode (λ = 660 nm) will be applied with an output power of 100mW . The laser head will be positioned in direct contact with the pseudo periodontal pocket.
Procedure: scaling and root planing (SRP) + PDT
Patientes will receive periodontal treatment (scaling and root planing - SRP) with the ultrasound. The SRP will be done in one session. The PDT placebo wil be done using an agent with the same vehicle as that of the methylene blue to mimic irrigation with the photosensitizer; the laser will be switched off at the time of application.
patients will receive the same scaling and root planing treatment that placebo group.However the PDT will be done only on one side of mouth using methylene blue 0.005% .The red laser diode (λ = 660 nm) will be applied with an output power of 100mW . The laser head will be positioned in direct contact with the pseudo periodontal pockets.
Gingival bleeding index
The periodontal probe will be inserted at all predetermined sites at the gingival margin of all teeth, 30 seconds will be waited and, at the smallest sign of bleeding, the presence or absence of bleeding will be noted. Gingival bleeding will be evaluated at 4 sites (mesiobuccal, distobuccal, mesiolingual, distolingual.The gingival Index will be presented in a percentage (%). The result will be based on the ratio of total sites to sites affected. Results will be considered indicative of gingivitis with ≥ 10% bleeding . It will be assessed at baseline and 30 days after treatment.
Time frame: through study completion on average of one year
Clinical probing depth (PD)
Will be done by a calibrated evaluator using a periodontal probe marked in millimeters (North Carolina University periodontal probe, UNC-15 (Hu-FriedyTM): all teeth (except third molars) will be evaluated at 4 sites (mesiobuccal, distobuccal, mesiolingual, distolingual) using the aforementioned parameters. The Northe Carolina University periodontal probe will be insert in the gingival sulcus. Probing depths to be evaluated in millimeters (mm) from the base of the periodontal pocket to the free gingival margin. It will be assesed at baseline and 30 days after treatment.
Time frame: through study completion on average of one year
Evaluation of crevicular fluid cytokines IL-6, IL-1β, and IL-10,
Evaluation of cytokines IL-6, IL-1β, , and IL-10, will be done via the ELISA. The paper cones will be inserted at regions with gingivitis and gingival hyperplasia (pseudo pocket) until resistance be felt. The cone will remain in this position for 30 seconds. If there is blood contamination a new cone will be used after 90 seconds. Eight cones must be collected, one for each site. The cones will be placed in a 1.5ml microcentrifuge tube and stored at -80 °C. It will be assesed at baseline and 30 days after treatment;
Time frame: through study completion on average of one year
Visible plaque index (PI)
Will be visualy evalueted before of probing depht, using the following score of visible supragingival plaque: Presence = 1 Absence = 0 It will be assessed at baseline and 30 days after treatment
Time frame: through study completion on average of one year
Plan to share: No
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