Treatment of Halitosis With Photodynamic Therapy in Older Patients

NCT03591484 | Completed

• 1 other identifier: Halidosos
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Halitosis

Keywords

Halitosis; photodynamic therapy; bronchiectasis

Outcome Measures

Primary Outcomes (1)

• Halimetry (gas chromatography test)

  The portable Oral ChromaTM will be used for the assessment of halitosis. 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and the participant will breathe through the nose with the mouth closed for one minute.The plunger will then be withdrawn to fill the chamber with air.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 and immediately after treatment.

  study completion an average of 1 year

Secondary Outcomes (1)

• Microbiological evaluation of tongue coating

  study completion an average of 1 year

Study Arms (4)

G1 dentate healthy older

EXPERIMENTAL

Treatment with Photodynamic therapy (n = 20). The dentate participants will received periodontal treatment. The evaluation of halitosis and the microbiological analysis will be repeated before these steps

Radiation: Photodynamic therapy; Procedure: Periodontal treatment

G2 healthy older/dentures

EXPERIMENTAL

Treatment with Photodynamic therapy (n = 20). The participants will be submitted to hygiene procedures for the mucosa and dentures. The evaluation of halitosis and the microbiological analysis will be repeated before these steps

Radiation: Photodynamic therapy; Procedure: hygiene procedures for the mucosa and dentures

G3 dentate older bronchiectasis

ACTIVE COMPARATOR

Treatment with tongue scraper (n = 20). The dentate participants with bronchiectasis will received periodontal treatment. The evaluation of halitosis and the microbiological analysis will be repeated before these steps

Device: Treatment with tongue scraper; Procedure: Periodontal treatment

G4 older bronchiectasis /dentures

ACTIVE COMPARATOR

Treatment with tongue scraper (n = 20). The participants will be submitted to hygiene procedures for the mucosa and dentures. The evaluation of halitosis and the microbiological analysis will be repeated before these steps

Device: Treatment with tongue scraper; Procedure: hygiene procedures for the mucosa and dentures

Interventions

Photodynamic therapy RADIATION

Treatment with Photodynamic therapy. The evaluation of halitosis and the microbiological analysis will be repeated before this step

G1 dentate healthy older; G2 healthy older/dentures

Treatment with tongue scraper DEVICE

Treatment with tongue scraper. The evaluation of halitosis and the microbiological analysis will be repeated before this step

G3 dentate older bronchiectasis; G4 older bronchiectasis /dentures

Periodontal treatment PROCEDURE

Periodontal treatment will be performed with curettes and ultrassom. The evaluation of halitosis and the microbiological analysis will be repeated before this step

G1 dentate healthy older; G3 dentate older bronchiectasis

hygiene procedures for the mucosa and dentures PROCEDURE

edentulous participants will be submitted to hygiene procedures for the mucosa and dentures. The evaluation of halitosis and the microbiological analysis will be repeated before this step

G2 healthy older/dentures; G4 older bronchiectasis /dentures

Eligibility Criteria

• Age: 60 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 60 years or older
• Halitosis positive: ≥ 112 ppbin the gas chromatography test
• Patients with or without a diagnosis of bronchiectasis
• Patients with more than 10 natural teeth or using complete upper and lower dentures.

You may not qualify if:

• Smokers or ex-smokers having quit less than five years ago
• Patients with a diagnosis of cystic fibrosis (which, although is a lung disease, has a genetic etiology)
• Patients with hypersensitivity to the photosensitizing agent used in PDT

Sponsors & Collaborators

• University of Nove de Julho: lead

Study Sites (1)

University of Nove de Julho (UNINOVE)

São Paulo, 01504-001, Brazil

Location

MeSH Terms

Conditions

Halitosis; Bronchiectasis

Interventions

Photochemotherapy; Therapeutics; Periodontal Index; Dentures

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Bronchial Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Drug Therapy; Phototherapy; Dental Health Surveys; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Dentistry; Periodontics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Dentistry; Dental Prosthesis; Prosthodontics; Prostheses and Implants; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: July 8, 2018
• First Posted: July 19, 2018
• Study Start: June 1, 2019
• Primary Completion: December 1, 2020
• Study Completion: August 1, 2021
• Last Updated: June 29, 2023

Record last verified: 2018-07

Locations

BR (1)