Evaluation of the Treatment of Halitosis With Photodynamic Therapy in Older Patients With Complete Denture

NCT03960983 | Completed

• 1 other identifier: Halitose PT
• 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 and diabetes 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 denture. A randomized, controlled trial is proposed. The patients will be divided into 2 groups: G1: older adults who wear complete dentures and will be treater with tongue scraper (n = 20); G2 older adults who wear complete dentures and will be treater with PDT (n = 20). If the halitosis persists, the participants will be submitted to hygiene procedures for the mucosa and dentures. The evaluation of halitosis will be repeated. If the halitosis is resolved, the participants will return after one week for an additional evaluation. This protocol will determine the effectiveness of photodynamic therapy regarding the reduction of halitosis in older adults with complete denture.

Conditions

Halitosis

Keywords

Halitosis; photodynamic therapy; elderly; denture

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and the participant will breathe through the nose with the mouth closed for one minute.The plunger will then be withdrawn to fill the chamber with air.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]

Study Arms (2)

Elderly pacients with complete dentures and Tongue Scraper

EXPERIMENTAL

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

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

Elderly pacients with complete dentures and PDT

ACTIVE COMPARATOR

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

Interventions

Treatment with tongue scraper DEVICE

Treatment with tongue scraper. the evaluation of halitosis will be repeated before this step.

Elderly pacients with complete dentures and Tongue Scraper

Hygiene procedures for the mucosa and dentures PROCEDURE

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

Elderly pacients with complete dentures and Tongue Scraper

Photodynamic Therapy RADIATION

Treatment with Photodynamic therapy. The evaluation of halitosis will be repeated before this step

Elderly pacients with complete dentures and PDT

Eligibility Criteria

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

You may qualify if:

• Men and women aged 60 years or older using complete dentures
• Halitosis positive: ≥ 112 ppbin the gas chromatography test

You may not qualify if:

• Dentate patients and edentulous with no complete denture hypersensitivity to the photosensitizing agent used in PDT, H2S \< 112ppb

Sponsors & Collaborators

• University of Nove de Julho: lead

Study Sites (1)

Anna Carolina R.T. Horliana

São Paulo, São Paulo, 11030-480, Brazil

Location

Related Publications (1)

• Vale KLD, Horliana ACRT, Romero SDS, Deana AM, Goncalves MLL, Ferrari RAM, Bussadori SK, Fernandes KPS. Evaluation of the treatment of halitosis with photodynamic therapy in older patients with complete denture: Protocol for a randomized, controlled trial. Medicine (Baltimore). 2019 Jul;98(27):e16275. doi: 10.1097/MD.0000000000016275.

  PMID: 31277154 DERIVED

MeSH Terms

Conditions

Halitosis

Interventions

Therapeutics; Dentures; Photochemotherapy

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dental Prosthesis; Prosthodontics; Dentistry; Prostheses and Implants; Equipment and Supplies; Combined Modality Therapy; Drug Therapy; Phototherapy

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

Study Record Dates

• First Submitted: May 21, 2019
• First Posted: May 23, 2019
• Study Start: June 1, 2019
• Primary Completion: December 1, 2020
• Study Completion: August 1, 2021
• Last Updated: June 29, 2023

Record last verified: 2019-05

Locations

BR (1)