NCT03591484

Treatment of Halitosis With Photodynamic Therapy in Older Patients

Completed NA Last updated 29 June 2023

What this trial tests

NA trial testing Photodynamic therapy in Halitosis in 40 participants. Completed in 1 August 2021.

Timeline

1 June 2019

Primary endpoint
1 December 2020

1 August 2021

Quick facts

Lead sponsor	University of Nove de Julho
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	40
Start date	1 June 2019
Primary completion	1 December 2020
Estimated completion	1 August 2021
Sites	1 location across Brazil

Drugs / interventions tested

• Photodynamic therapy — full drug profile →
• Treatment with tongue scraper
• Periodontal treatment
• hygiene procedures for the mucosa and dentures

Conditions studied

• Halitosis — all drugs for Halitosis →

Sponsor

University of Nove de Julho

Who can join

Adults 60 to 100, any sex, with Halitosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Halitosis is the term used to define an unpleasant odor emanating from the mouth. Some lung diseases, such as bronchiectasis, are among the extra-oral causes of this condition. However, no studies have evaluated the causes and treatment of halitosis in the population of older adults with bronchiectasis. Methods and analysis: A randomized, controlled trial is proposed. The patients will be divided into four groups: G1- healthy older adults with 10 teeth or more (n = 40); G2- healthy older adults who wear complete dentures (n = 40); G3- older adults with bronchiectasis and 10 teeth or more (n = 40); and G4- older adults with bronchiectasis who wear complete dentures (n = 40). Halitosis will be evaluated based on the measurement of volatile sulfur compounds using gas chromatography. The participants with halitosis will be randomized into two subgroups: treatment with photodynamic therapy (n = 20) or cleaning of the tongue with a tongue scraper (n = 20). After the treatments, a second evaluation will be performed, along with a microbiological analysis (qPCR) for the identification of the bacteria P. gingivalis and T. denticola. If the halitosis persists, the dentate participants will received periodontal treatment and the edentulous participants will be submitted to hygiene procedures for the mucosa and dentures. The evaluation of halitosis and the microbiological analysis will be repeated. If the halitosis is resolved, the participants will return after three months for an additional evaluation. This protocol will determine the effectiveness of phototherapy regarding the reduction of halitosis in healthy older adults and those with bronchiectasis.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Interventions for managing halitosis.
   Kumbargere Nagraj S, Eachempati P, Uma E, Singh VP, et al · · 2019 · cited 29× · PMID 31825092 · DOI 10.1002/14651858.cd012213.pub2