Evaluation of Halitosis After Treatment With Photodynamic Therapy Associated With Periodontal Treatment

NCT03996915 | Completed DMC

• 1 other identifier: Halitosis healthy patients
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this randomized, controlled clinical trial was to treat oral halitosis in healthy adults with photodynamic therapy associated with periodontal treatment and follow them up for 3 months. The participants with halitosis will be randomized into two groups: G1-treatment with photodynamic therapy or G2-cleaning of the tongue with a tongue scraper . Halitosis were evaluated measuring volatile sulfur compounds using gas chromatography After the treatments, a second evaluation will be performed, along with a microbiological analysis (qPCR) for the identification of the bacteria T. denticola

Conditions

Halitosis

Keywords

photodynamic therapy; periodontal disease; randomized controlled clinical study

Outcome Measures

Primary Outcomes (1)

• halitosis measurement (gas chromatography test)

  The portable Oral Chroma will be used for the assessment of halitosis. Oral air collection will follow the manufactured guide lines (Oral Chroma Manual Instruction). A syringe will be placed in the patient's mouth with the plunger completely inserted and the participant will breathe through the nose with the mouth closed for one minute.The plunger will then be withdrawn to fill the chamber with air. This procedure will be repeated. The gas injection needle will be placed on the syringe and the plunger will be adjusted to 0.5 ml. This air will be injected into the input of the device in a single motion. This procedure will be done before, immediately after PDT or scraper and after periodontal treatment.

  through study completion on average of one year

Secondary Outcomes (1)

• microbiological analysis

  through study completion on average of one year

Study Arms (2)

experimental PDT group

EXPERIMENTAL

G1-20 patients Photodynamic therapy with methylene blue as photosensitizer device irradiation with low intensity laser (wave length = 660 nm) 9 J (Joules) per point (6 points) and radiant 90 seconds. Photosensitiser (PS) will be applied in sufficient quantity to cover the middle third and back of the tongue and wait for 5 minutes.Six points with the distances of 1 cm between them will be irradiated.

Device: Pdt Photodynamic Therapy

control tongue scrapper group

ACTIVE COMPARATOR

G2-20 patients Tongue scrapping will be performed by the same operator in all patients. Posterior -anterior movements will be performed with the scrapper over the lingual dorsum in order to promote the mechanical removal of tongue coating

Other: tongue scrapper

Interventions

Pdt Photodynamic Therapy DEVICE

device irradiation with low intensity laser (wave length = 660 nm) 9 J (Joules) per point(6 points) and radiant 90 seconds PS will be applied in sufficient quantity to cover the middle third and back of the tongue and wait for 5 minutes.six points with the distances of 1 cm between them will be irradiated.

experimental PDT group

tongue scrapper OTHER

Tongue scrapping will be performed by the same operator in all patients. Posterior -anterior movements will be performed with the scrapper over the lingual dorsum. in order to promote the mechanical removal of tongue coating

control tongue scrapper group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Both genders
• with at least 10 teeth
• Periodontal screening and recording (PSR) 0, 1 or 2
• without any changes in the anatomy of the back of the tongue (geographical or fissured tongue)
• positive halitosis (SH2 level higher than 112 ppb).

You may not qualify if:

• smokers
• ex-smokers for less than 5 years
• patients with hypersensitivity to the photosensitizer.

Sponsors & Collaborators

• University of Nove de Julho: lead

Study Sites (1)

Nove de Julho University (UNINOVE)

São Paulo, 01504-001, Brazil

Location

Related Publications (4)

• 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

• Romero SDS, Schalch TO, do Vale KL, Ando ES, Mayer MPA, Feniar JPG, Fernandes KPS, Bussadori SK, Motta LJ, Negreiros RM, Tempestini Horliana ACR. Evaluation of halitosis in adult patients after treatment with photodynamic therapy associated with periodontal treatment: Protocol for a randomized, controlled, single-blinded trial with 3-month follow up. Medicine (Baltimore). 2019 Sep;98(39):e16976. doi: 10.1097/MD.0000000000016976.

  PMID: 31574796 DERIVED

MeSH Terms

Conditions

Halitosis; Periodontal Diseases

Interventions

Ultraviolet Therapy

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Phototherapy; Therapeutics

Study Officials

• Anna Carolina rt Horliana, phd

  Nove de Julho University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: single blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Phd, clinical professor

Model Details: Bio-equivalence Study Enrollment:40

Study Record Dates

• First Submitted: June 22, 2019
• First Posted: June 25, 2019
• Study Start: January 1, 2019
• Primary Completion: November 1, 2019
• Study Completion: December 1, 2019
• Last Updated: June 29, 2023

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)