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

U

University of Nove de Julho

Status

Completed

Conditions

Halitosis

Treatments

Device: Pdt Photodynamic Therapy
Other: tongue scrapper

Study type

Interventional

Funder types

Other

Identifiers

NCT03996915
Halitosis healthy patients

Details and patient eligibility

About

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

Full description

Halitosis is an unpleasant odor that emanating from the mouth. A recent metanalysis shows worldwide trend towards a rise in halitosis prevalence. Studies show halitosis returns in a week after treatment with photodynamic therapy (PDT). Probably, bacteria residing in the periodontal sulcus could recolonize the dorsum of the tongue. To date, there are no study in adult population that associate halitosis and periodontal treatment with follow-up evaluation. 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 (n=40) with halitosis will be randomized into two groups: G1-treatment with photodynamic therapy (n = 20) or G2-cleaning of the tongue with a tongue scraper (n = 20). 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. The evaluation of halitosis and the microbiological analysis will be repeated. After that, patients will receive periodontal treatment. The participants will return after 1 week and three months for an additional evaluation. Quality of life will be measured by Oral Health Impact Profile (OHIP-14) Comparisons will be made with ANOVA test, with the level of significance of 5 %. This protocol will determine the effectiveness of phototherapy regarding the reduction of halitosis in adults.

Enrollment

40 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • 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).

Exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

40 participants in 2 patient groups

experimental PDT group
Experimental group
Description:
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.
Treatment:
Device: Pdt Photodynamic Therapy
control tongue scrapper group
Active Comparator group
Description:
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
Treatment:
Other: tongue scrapper

Trial contacts and locations

1

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Central trial contact

renata RT matalon, phd

Data sourced from clinicaltrials.gov

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