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Clinical Trial Summary

Halitosis is the third most common oral condition perceived by the patients as pathologic, after caries and periodontal diseases. Although it is difficult to estimate the prevalence of halitosis in the population due to the different assessment methods, the available descriptive epidemiologic studies estimate that 30-50% of the population experience oral malodor. Pathologic halitosis most commonly (85%) originates from the oral cavity and is a result of bacterial deposits that cover the tongue or are found in the inflamed oral mucosa, under poor-quality restorations, orthodontic mechanisms, carious lesions or mucosal ulcers. Odor usually results from the microbial degradation of organic substrates present in saliva. This interaction generates malodorous volatile sulfur compounds (VSCs), of which the three most common are: hydrogen sulfide (H2S), methyl-mercaptan (CH3SH) and dimethyl sulfide [(CH3)2S]. Orthodontic patients with fixed appliances are more prone to halitosis, due to the increased plaque accumulation and the increased amounts of available nutrients for the supragingival and subgingival microbes .


Clinical Trial Description

AIM: The aim of this study is to investigate the effect of Mastic mouthwash on halitosis (Volatile Sulfur Compounds' levels, VSCs) as well as plaque and gingival indexes in patients undergoing orthodontic treatment with fixed appliances PARTICIPANTS AND METHOD: The study is a double-blinded, placebo-controlled, parallel group, randomized clinical trial. Thirty patients with fixed orthodontic appliances were randomly allocated at a 1:1 ratio, to either the mastic-mouthwash or the placebo-mouthwash group. Eligibility criteria included ages between 13 and 18, active orthodontic treatment with fixed appliances, good general health and total initial VSCs levels above the baseline level of 150ppb. The primary outcomes will be: (a) their subjective perception of their own malodor via questionnaires, (b) their objective VSCs levels (hydrogen sulfide (H2S), methyl-mercaptan (CH3SH) and dimethyl sulfide ((CH3)2S) through the OralChromaTM device and (c) oral hygiene assessed with the use of the Modified Silness and Löe Plaque Index (PI-M) and the Silness and Löe Gingival Index (GI). Measurements were taken at baseline (T0) and after 2 weeks (T1). ;


Study Design


Related Conditions & MeSH terms

  • Halitosis
  • Orthodontic Appliance Complication

NCT number NCT05647369
Study type Interventional
Source University of Athens
Contact
Status Completed
Phase N/A
Start date December 1, 2022
Completion date March 1, 2023

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