BackgroundChronic obstructive pulmonary disease (COPD) has been associated with periodontal disease (PD), and periodontal treatment (PT) has been connected to reduction of lung disease exacerbations. Bronchiectasis has many clinical similarities with COPD but, although it is also a chronic lung disease, to date it has not been studied with relation to PD. The aim of this study is to evaluate whether PT associated with photodynamic therapy (PDT) reduces the number of exacerbations, improves pulmonary function, periodontal clinical parameters and quality of life after 1 year of periodontal treatment follow-up.MethodsBronchiectasis patients will undergo medical anamnesis and periodontal examination. Participants with periodontitis will be divided into two groups and PT will be performed as G1 control group (n = 32) – OHO (oral hygiene orientation) + supragingival treatment + simulation of using photodynamic therapy (PDT); G2 experimental (n = 32) – scaling and root planing + PDT + OHO. Lung function will be assessed both at baseline and after 1 year by spirometry, exacerbation history will be analyzed through clinical records monitoring. Three instruments for quality of life assessment will also be applied – Saint George’s Respiratory Questionnaire and Impact Profile Analysis Oral health (OHIP-14). It is expected that periodontal treatment can improve the analyzed parameters after 1 year.DiscussionAlthough only one study evaluates exacerbation in COPD after 1 year of PT, bronchiectasis has not been studied in the dentistry field to date. Trial registration: NCT02514226. Version #1. This study protocol receives grant from FAPESP (São Paulo Research Foundation) #2015/20535-1. First received: July 22, 2015, 1st version. This protocol has been approved by the Research Ethics Committee of Nove de Julho University.
Background:
Halitosis is the term used to define an unpleasant odor emanating from the mouth. However, no studies have evaluated the causes and treatment of halitosis in the population of older adults with denture.
Methods:
A randomized, controlled trial is proposed. The patients will be divided into 2 groups: G1: older adults who wear complete dentures and will be treated with tongue scraper (n = 20); G2 older adults who wear complete dentures and will be treated 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 made before and after treatments, with OralChroma
TM
. If the halitosis is solved, the participants will return after 1 week for an additional evaluation. Oral Health Impact Profile (OHIP-14) will be administered by a calibrated examiner on the day the patient history is taken (baseline) and 1 week after treatment for halitosis.
Discussion:
This protocol will determine the effectiveness of photodynamic therapy regarding the reduction of halitosis in older adults with complete denture.
Trial registration:
This protocol was registered in ClinicalTrial.gov, under number NCT03960983. It was first posted and last updated in May 23, 2019.
https://clinicaltrials.gov/ct2/show/NCT03960983
.
Rationale:Halitosis is an unpleasant odor that emanates from the mouth. Studies show halitosis returns in a week, after treatment with PDT. Probably, bacteria living in the periodontal sulcus could recolonize the dorsum of the tongue. Until nowadays, there are no study in adult population that associates halitosis and periodontal treatment with follow-up evaluation. The aim of this randomized, controlled, single-blinded clinical trial is to treat oral halitosis in healthy adults with photodynamic therapy (PDT), associated with periodontal treatment and follow them up for 3 months.Patient concerns:the concerns assessments will be done over the study using anamnesis interviews and specific questionnaire.Diagnoses:halitosis will be evaluated by OralChroma.Interventions:The participants (n = 40) with halitosis will be randomized into 2 groups: G1-treatment with PDT (n = 20) or G2-cleaning of the tongue with a tongue scraper (n = 20).Outcomes:Halitosis will be evaluated by measuring volatile sulfur compounds using gas chromatography. After the treatments, a second evaluation will be performed, along with a microbiological analysis (RT-PCR) for the identification of the bacteria T. denticola. The assessment of halitosis and the microbiological analysis will be repeated. After that, patients will receive periodontal treatment. The participants will return after 1 week and 3 months for an additional evaluation. Quality of life will be measured by Oral Health Impact Profile questionnaire (OHIP-14).Lessons:This protocol will determine the effectiveness of phototherapy regarding the reduction of halitosis in adults. clinicaltrials.gov NCT 03996915.Ethics and dissemination:This protocol received approval from the Human Research Ethics Committee of Universidade Nove de Julho (certificate number: 3.257.104). The data will be published in a peer-reviewed periodical.
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