Photodynamic Therapy in Patients With Gingivitis

Last updated on July 2021

Recruitment

Recruitment Status: Not yet recruiting
Estimated Enrollment: Same as current

Summary

Conditions

Gingivitis
Orthodontic Appliance Complication
Photodynamic Therapy

Type

Interventional

Phase

Not Applicable

Design

Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Patients will be divided into two groups: Control group (n = 17) - Scaling and Root Planing (SRP) + PDT placebo and Experimental group (n = 17) - SRP + PDT.Masking: Double (Participant, Investigator)Masking Description: Only the researcher responsible for conducting the treatments (who will open the randomized envelopes) will know which treatment is assigned to each patient. The identification of each group will only be revealed by this researcher after statistical analysis of the data for all those involved in the study. Therefore, the researcher responsible for data collection, the microbiologist and the statistician will be blind regarding the treatments assigned to the groups. The patient will also be blind to the type of treatment performed since the periodontal treatment will be identical in both groups and treatment with PDT will be simulated in the control group.Primary Purpose: Treatment

Participation Requirements

Age: Between 10 years and 30 years
Gender: Both males and females

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 hyperplasia 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 immunoregulatory and microbiological parameters in patients with gingivitis with the predisposing factor of the use of a fixed orthodontic appliance. A randomized, controlled, double-blind clinical study will include 34 patients, both genders, having used the fixed appliance for more than 12 months, with gingivitis present. Patients will be 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%, ? = 660nm, 9J (joule) per inflamed site, irradiance = 3.5W / cm, radiant exposure = 318J / cm2 . In G1 the scaling will be performed with the aid of curettes and ultrasound. All participants will receive oral hygiene guidance (OHG) prior to SRP. 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 (from 8 pre-determined sites) and non-stimulated saliva for analysis of the IL-6, IL-1?, IL-8, TNF-? and IL-10 cytokines will be collected using the ELISA method. In addition, the Universal bacteria count (16S rRNA gene) will also be performed by qPCR using the same secretions. All analysis will be realized using the baseline (T0), 7 (T1) and 21 (T2) days after treatment. Oral health-related quality of life (OHRQoL) will be assessed using the OHIP-14 questionnaire at times T0 and T2. 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.

Tracking Information

NCT #: NCT04037709
Collaborators: Not Provided
Investigators: Principal Investigator: Anna carolina RT Horliana, Phd Nove de Julho University