Photodynamic Therapy in Patients With Gingivitis

NCT04037709 | Completed DMC

• 1 other identifier: PDT
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gingivitis; Orthodontic Appliance Complication; Photodynamic Therapy

Outcome Measures

Primary Outcomes (1)

• 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.

  through study completion on average of one year

Secondary Outcomes (2)

• Clinical probing depth (PD)

  through study completion on average of one year

• Evaluation of crevicular fluid cytokines IL-6, IL-1β, and IL-10,

  through study completion on average of one year

Other Outcomes (1)

• Visible plaque index (PI)

  through study completion on average of one year

Study Arms (2)

scaling and root planing (SRP) + PDT placebo

PLACEBO COMPARATOR

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

scaling and root planing (SRP) + PDT

EXPERIMENTAL

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

Interventions

scaling and root planing (SRP) + PDT placebo PROCEDURE

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.

scaling and root planing (SRP) + PDT placebo

scaling and root planing (SRP) + PDT PROCEDURE

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.

scaling and root planing (SRP) + PDT

Eligibility Criteria

• Age: 10 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• healthy participants (negative medical history),
• of both genders,
• aged 10 to 30 years,
• with gingivitis induced by dental biofilm,
• predisposed by the use of a fixed orthodontic appliance, according to the classification of 2018

You may not qualify if:

• participants with maxillary and mandibular deformities,
• periodontitis,
• oral lesions and who have used antibiotics for less than 3 months,
• those who have used non-steroidal anti-inflammatory drugs and continuous corticosteroid therapy for less than 3 months,
• who have been using mouthwash in the past 3 months.
• Participants who have modifying factors for periodontal disease, such as diabetics, immunosuppressive smokers (cyclosporine), anticonvulsants (phenytoin), calcium channel blockers (nifedipine) and pregnant and lactating women as well as those who are HIV positive, or have Hepatitis B or C. - Patients who require prophylactic antibiotic therapy for periodontal treatment - who have had periodontal treatment in the last 6 months.
• Patients who have non-biofilm-induced gum disease.
• Patients who for some reason during the study have to initiate the use of the medicines and mouthwashes mentioned above or acquire a disease that is a modifying factor for periodontal disease or become pregnant.
• Patients who do not wish to remain part of the study may drop out whenever they wish.

Sponsors & Collaborators

• University of Nove de Julho: lead

Study Sites (1)

Anna Carolina R.T. Horliana

São Paulo, São Paulo, 11030-480, Brazil

Location

Related Publications (4)

• Schalch TO, Palmieri M, Longo PL, Braz-Silva PH, Tortamano IP, Michel-Crosato E, Mayer MPA, Jorge WA, Bussadori SK, Pavani C, Negreiros RM, Horliana ACRT. Evaluation of photodynamic therapy in pericoronitis: Protocol of randomized, controlled, double-blind study. Medicine (Baltimore). 2019 Apr;98(17):e15312. doi: 10.1097/MD.0000000000015312.

  PMID: 31027098 BACKGROUND

• Gomez C, Abellan R, Palma JC. Efficacy of photodynamic therapy vs ultrasonic scaler for preventing gingival inflammation and white spot lesions during orthodontic treatment. Photodiagnosis Photodyn Ther. 2018 Dec;24:377-383. doi: 10.1016/j.pdpdt.2018.11.001. Epub 2018 Nov 3.

  PMID: 30399455 RESULT

• Chapple ILC, Mealey BL, Van Dyke TE, Bartold PM, Dommisch H, Eickholz P, Geisinger ML, Genco RJ, Glogauer M, Goldstein M, Griffin TJ, Holmstrup P, Johnson GK, Kapila Y, Lang NP, Meyle J, Murakami S, Plemons J, Romito GA, Shapira L, Tatakis DN, Teughels W, Trombelli L, Walter C, Wimmer G, Xenoudi P, Yoshie H. Periodontal health and gingival diseases and conditions on an intact and a reduced periodontium: Consensus report of workgroup 1 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. J Periodontol. 2018 Jun;89 Suppl 1:S74-S84. doi: 10.1002/JPER.17-0719.

  PMID: 29926944 RESULT

• Rosa EP, Murakami-Malaquias-Silva F, Schalch TO, Teixeira DB, Horliana RF, Tortamano A, Tortamano IP, Buscariolo IA, Longo PL, Negreiros RM, Bussadori SK, Motta LJ, Horliana ACRT. Efficacy of photodynamic therapy and periodontal treatment in patients with gingivitis and fixed orthodontic appliances: Protocol of randomized, controlled, double-blind study. Medicine (Baltimore). 2020 Apr;99(14):e19429. doi: 10.1097/MD.0000000000019429.

  PMID: 32243363 DERIVED

MeSH Terms

Conditions

Gingivitis

Interventions

Tooth Exfoliation; Root Planing; 1-phenyl-3,3-dimethyltriazene

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Dental Scaling; Dental Prophylaxis; Periodontics; Dentistry; Subgingival Curettage; Preventive Dentistry

Study Officials

• Anna Carolina R Horliana, Phd

  Nove de Julho University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, clinical professor

Model Details: 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.

Study Record Dates

• First Submitted: July 24, 2019
• First Posted: July 30, 2019
• Study Start: November 9, 2020
• Primary Completion: December 1, 2021
• Study Completion: March 15, 2022
• Last Updated: October 11, 2023

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)