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

Primary Purpose

Halitosis

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Treatment with tongue scraper
Hygiene procedures for the mucosa and dentures
Photodynamic Therapy
Hygiene procedures for the mucosa and dentures
Sponsored by
University of Nove de Julho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Halitosis focused on measuring Halitosis, photodynamic therapy, elderly, denture

Eligibility Criteria

60 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Men and women aged 60 years or older using complete dentures

  • • Halitosis positive: ≥ 112 ppbin the gas chromatography test

Exclusion Criteria:

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

Sites / Locations

  • Anna Carolina R.T. Horliana

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Elderly pacients with complete dentures and Tongue Scraper

Elderly pacients with complete dentures and PDT

Arm Description

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

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

Outcomes

Primary Outcome Measures

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and the participant will breathe through the nose with the mouth closed for one minute.The plunger will then be withdrawn to fill the chamber with air.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

Secondary Outcome Measures

Full Information

First Posted
May 21, 2019
Last Updated
June 27, 2023
Sponsor
University of Nove de Julho
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1. Study Identification

Unique Protocol Identification Number
NCT03960983
Brief Title
Evaluation of the Treatment of Halitosis With Photodynamic Therapy in Older Patients With Complete Denture
Official Title
Evaluation of the Treatment of Halitosis With Photodynamic Therapy in Older Patients With Complete Denture: Protocol for a Randomized, Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
December 1, 2020 (Actual)
Study Completion Date
August 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Nove de Julho

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Methods: A single-center, randomized, controlled, single-blind clinical trial was designed in accordance with the criteria recommended for interventional trials in the SPIRIT Statement. The project for the proposed study received approval from the Human Research Ethics Committee of Universidade Nove de Julho. Selection of individuals - characterization of sample - Two groups will be composed of older adults (60 years or older) in treatment at the dental clinic of Universidade Nove de Julho. After verbal and written explanations of the study, those who agree to participate will sign a statement of informed consent approved by the Human Research Ethics Committee of Universidade Nove de Julho. The study will be conducted in compliance with the precepts stipulated in the Declaration of Helsinki (revised in Fortaleza, Brazil, 2013). Calculation of sample size - Initially an error err=|(x_1 ) ̅-(x_2 ) ̅ | was established, where the mean values of groups G1 and G2 whose variances are σ_1^2e σ_2^2, respectively. The effect size was calculated by: effect size=err/√(σ_1^2+σ_2^2 ) If the normal distribution hypothesis is rejected, the sample size should be corrected by approximately 5%. Observing statistical samples from the reference Mota et al., 2016; to estimate the mean values and sample variance we obtain the following sample sizes for each group: Sample Size Group Group Sample Size G1 18 G2 18 Inclusion criteria - Men and women aged 60 years or older using complete dentures. Exclusion criteria - Dentate patients and edentulous with no complete denture hypersensitivity to the photosensitizing agent used in PDT, H2S < 112ppb. Training and calibration of examiner - An examiner (gold standard) will perform training and calibration exercises to maximize the reproducibility of the measurements. For such, 10 individuals with halitosis will be evaluated using the Oral Chroma® device. These individuals will not participate in the main study. The intraclass correlation coefficient (ICC) will be calculated for the determination of intra-examiner agreement (≥ 0.90) with regard to the halitosis readings. Randomization - The 40 individuals with complete denture will be randomized in two groups: Group A (20 individuals submitted to treatment with a tongue scraper) and Group B (20 individuals submitted to treatment with PDT). Opaque envelopes will be identified with sequential numbers (1 to 40) and will contain pieces of paper with the information of the corresponding experimental group (A or B). Blocked randomization will be performed in blocks of five patients (eight blocks for both treatments; example of a block: AABAB). The envelopes will be sealed and kept in numerical order in a safe place until the time of the treatments. The randomization and preparation of the envelopes will be performed by a researcher who will not otherwise participate in the study. Randomization will be performed using Microsoft Excel, version 2013. Characterization of the study - The experimental design will consist of two groups: G1- older adults with halitosis (SH2 ≥ 112 ppb) who wear complete dentures and treatment with a tongue scraper (n = 20); G2- older adults with halitosis (SH2 ≥ 112 ppb) who wear complete dentures and treatment with PDT (n = 20). The evaluation of halitosis will be performed at baseline (1st session), after treatment with a tongue scraper or PDT (1st session) and after one week (2nd session)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Halitosis
Keywords
Halitosis, photodynamic therapy, elderly, denture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Elderly pacients with complete dentures and Tongue Scraper
Arm Type
Experimental
Arm Description
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
Arm Title
Elderly pacients with complete dentures and PDT
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Treatment with tongue scraper
Intervention Description
Treatment with tongue scraper. the evaluation of halitosis will be repeated before this step.
Intervention Type
Procedure
Intervention Name(s)
Hygiene procedures for the mucosa and dentures
Intervention Description
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
Intervention Type
Radiation
Intervention Name(s)
Photodynamic Therapy
Intervention Description
Treatment with Photodynamic therapy. The evaluation of halitosis will be repeated before this step
Intervention Type
Procedure
Intervention Name(s)
Hygiene procedures for the mucosa and dentures
Intervention Description
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
Primary Outcome Measure Information:
Title
Halimetry (Gas Chromatography test)
Description
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.
Time Frame
study completion an average of 1 year]

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Men and women aged 60 years or older using complete dentures • Halitosis positive: ≥ 112 ppbin the gas chromatography test Exclusion Criteria: Dentate patients and edentulous with no complete denture hypersensitivity to the photosensitizing agent used in PDT, H2S < 112ppb
Facility Information:
Facility Name
Anna Carolina R.T. Horliana
City
São Paulo
State/Province
SP
ZIP/Postal Code
11030-480
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
31277154
Citation
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.
Results Reference
derived

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

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