Evaluation of Photodynamic Therapy in Pericoronitis

NCT03576105 | Unknown DMC

• 1 other identifier: pericoronitis
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

In order to reduce the chances of systemic dissemination of the infection and the use of antibiotics, it is mandatory to test effective treatments in the initial phase of pericoronitis aiming to avoid the evolution of the infectious disease. Photodynamic therapy (PDT) is an interesting alternative because it is an effective antimicrobial treatment that is easy to perform and does not cause bacterial resistance. The aim of this study is to evaluate the effectiveness of photodynamic therapy (PDT) with methylene blue in a surfactant vehicle in pericoronitis in the initial phase in healthy youngsters through microbiological, clinical and immunoregulatory response. The impact of pericoronitis on oral health-related quality of life (OHRQoL) of these patients will also be evaluated. 34 healthy young patients with pericoronitis will be evaluated. Microbiological analysis will be performed by RT-PCR for the bacterium Tannarella forsithia (Tf).Gingival crevicular fluid will be collected to evaluate TNF-α, IL1-β, IL-6 and IL-8 and IL-10 by the Luminex assay. The variables will be pain (visual analogue scale), edema, trismus (digital caliper) and oral health-related quality of life (OHRQoL) will also be evaluated through the OHIP-14 questionnaire. The variables will be assessed at T1 (baseline)and T2 (4th day after PDT).

Conditions

Pericoronitis

Keywords

third molar; pericoronitis; photodynamic therapy; microbiological analysis; laser; randomized controlled clinical study

Outcome Measures

Primary Outcomes (1)

• Microbiological analysis will be performed by RT-PCR for the bacterium Tannarella forsithia (Tf)

  Sample collection for microbiological analysis Biofilm collection will be done at two points of the vestibular gingival sulcus of the lower third molar using minifive curettes. The collected material will be maintained in TE (Tris-EDTA), conditioned in microtubes and later transported for laboratory analysis in the Microbiology Laboratory of ICB-USP Prof. Marcia Mayer

  change from baseline, immediately after PDT and on fourth day after PDT

Secondary Outcomes (6)

• Profile of cytokines Gingival crevicular fluid will be collected

  change from baseline and on fourth day after PDT

• pain assessed by Vas

  change from baseline, immediately after PDT and on fourth day after PDT

• edema assessed by measuring facial distance

  change from baseline, immediately after PDT and on fourth day after PDT

• trismus assessed by measuring bucal opening

  change from baseline, immediately after PDT and on fourth day after PDT

• OHRQoL assessed by ohip-14

  change from baseline, immediately after PDT and on fourth day after PDT

Study Arms (2)

experimental group

EXPERIMENTAL

G1 - 17 patients Photodynamic therapy with convention methylene blue as photosesintizer irrigation /sterile saline Conventional methylene blue as photosensitizer -Irrigation with 0,04mL of photosensitizer (0,005%) inside the gingival sulcus around the third molar with pericoronarite for 3 minutes Photodynamic therapy -Device irradiation with low intensity laser λ = 660 nm, 9J per point and radiant 90 seconds

Combination Product: irrigation /sterile saline; Combination Product: Conventional methylene blue as photosensitizer; Combination Product: Photodynamic therapy

positive control group

ACTIVE COMPARATOR

G2 - 17 patients Photodynamic therapy with oral formula of methylene blue as photosesintizer, treatment identical to G1, however methylene blue will be delivered in a new formulation for oral use (patent aplicattion INPI BR1020170253902) irrigation /sterile saline Photodynamic therapy -Methylene blue for oral use as photosensitizer-Irrigation with 0,04mL of photosensitizer (0,005%) inside the gingival sulcus around the third molar with pericoronarite for 3 minutes Device irradiation with low intensity laser λ = 660 nm, 9J per point and radiant 90 seconds

Combination Product: irrigation /sterile saline; Combination Product: Methylene blue for oral use as photosensitizer; Combination Product: Photodynamic therapy

Interventions

irrigation /sterile saline COMBINATION_PRODUCT

mechanical removal of bacteria with sterile saline

experimental group; positive control group

Conventional methylene blue as photosensitizer COMBINATION_PRODUCT

Irrigation with 0,04mL of photosensitizer (0,005%) inside the gingival sulcus around the third molar with pericoronarite for 3 minutes

Also known as: photodynamic therapy with conventional methylene blue

experimental group

Methylene blue for oral use as photosensitizer COMBINATION_PRODUCT

Irrigation with 0,04mL of photosensitizer(0,005%) inside the gingival sulcus around the third molar with pericoronarite for 3 minutes

Also known as: photodynamic therapy with methylene blue for oral use

positive control group

Photodynamic therapy COMBINATION_PRODUCT

Red laser for photodynamic therapy (Therapy XT,DMC,Sao Carlos,Sao Paulo,Brazil) Device irradiation with low intensity laser λ = 660 nm, 9J per point and radiant 90 seconds

Also known as: PDT

experimental group; positive control group

Eligibility Criteria

• Age: 13 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients should have at least one lower third partially visible molar in the oral cavity to be examined (Lower third molar erupted or partially erupted, with pericoronitis)
• All patients, regardless of age, gender, cultural level or socioeconomic status may participate in the research.

You may not qualify if:

• patients allergic to methylene blue
• pregnant or breastfeeding women,
• those with local infection (e.g., pericoronitis or periodontal abscess) presence of purulent exudate,
• those with fever (temperature above 37.8 C)
• Patients who have used anti-inflammatory drugs or antibiotic medications in the last three months will also be excluded.

Sponsors & Collaborators

• University of Nove de Julho: lead

Study Sites (1)

Nove de Julho University

São Paulo, 01504-001, Brazil

Location

Related Publications (6)

• da Silva T, da Silva FC, Gomes AO, Viana AO, Goncalves MLL, Rodrigues MFSD, Horliana ACRT, da Silva DFT, Chavantes MC, Fragoso YD, Branco LP, Motta LJ, Fernandes KPS, Mesquita-Ferrari RA, Bussadori SK. Effect of photobiomodulation treatment in the sublingual, radial artery region, and along the spinal column in individuals with multiple sclerosis: Protocol for a randomized, controlled, double-blind, clinical trial. Medicine (Baltimore). 2018 May;97(19):e0627. doi: 10.1097/MD.0000000000010627.

  PMID: 29742699 BACKGROUND

• Sobral APT, Godoy CLH, Fernandes KPS, Bussadori SK, Ferrari RAM, Horliana ACRT, Monken SF, Motta LJ. Photomodulation in the treatment of chronic pain in patients with temporomandibular disorder: protocol for cost-effectiveness analysis. BMJ Open. 2018 May 5;8(5):e018326. doi: 10.1136/bmjopen-2017-018326.

  PMID: 29730613 BACKGROUND

• da Cunha Moraes G, Vitoretti LB, de Brito AA, Alves CE, de Oliveira NCR, Dos Santos Dias A, Matos YST, Oliveira-Junior MC, Oliveira LVF, da Palma RK, Candeo LC, Lino-Dos-Santos-Franco A, Horliana ACRT, Gimenes Junior JA, Aimbire F, Vieira RP, Ligeiro-de-Oliveira AP. Low-Level Laser Therapy Reduces Lung Inflammation in an Experimental Model of Chronic Obstructive Pulmonary Disease Involving P2X7 Receptor. Oxid Med Cell Longev. 2018 Mar 4;2018:6798238. doi: 10.1155/2018/6798238. eCollection 2018.

  PMID: 29686745 BACKGROUND

• Okamoto CB, Motta LJ, Prates RA, da Mota ACC, Goncalves MLL, Horliana ACRT, Mesquita Ferrari RA, Fernandes KPS, Bussadori SK. Antimicrobial Photodynamic Therapy as a Co-adjuvant in Endodontic Treatment of Deciduous Teeth: Case Series. Photochem Photobiol. 2018 Jul;94(4):760-764. doi: 10.1111/php.12902. Epub 2018 Apr 30.

  PMID: 29420856 BACKGROUND

• Belotto RA, Chavantes MC, Tardivo JP, Euzebio Dos Santos R, Fernandes RCM, Horliana ACRT, Pavani C, Teixeira da Silva DF. Therapeutic comparison between treatments for Vulvar Lichen Sclerosus: study protocol of a randomized prospective and controlled trial. BMC Womens Health. 2017 Aug 10;17(1):61. doi: 10.1186/s12905-017-0414-y.

  PMID: 28793884 BACKGROUND

• 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 DERIVED

MeSH Terms

Conditions

Pericoronitis

Interventions

Therapeutic Irrigation; Photosensitizing Agents; Photochemotherapy; Methylene Blue; 1-phenyl-3,3-dimethyltriazene

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Hydrotherapy; Physical Therapy Modalities; Therapeutics; Rehabilitation; Investigative Techniques; Dermatologic Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Radiation-Sensitizing Agents; Combined Modality Therapy; Drug Therapy; Phototherapy; Phenothiazines; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Anna Carolina Ratto T Horliana, phd

  Nove de Julho university (UNINOVE)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: Endpoint Classification: Bio-equivalence Study Enrollment: 34 \[Anticipated\]

Study Record Dates

• First Submitted: June 6, 2018
• First Posted: July 3, 2018
• Study Start: December 1, 2019
• Primary Completion: April 20, 2024
• Study Completion: June 15, 2024
• Last Updated: June 29, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)