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Enrolling By Invitation
NCT05647369
Chios Mastic Mouthwash and Halitosis and Oral Hygiene in Orthodontic Patients
Conditions: Halitosis, Orthodontic Appliance Complication
Sex: All
Ages: 13 Years – 18 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 30
Sponsor: Iosif Sifakakis
Location: Greece
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 .
Eligibility Criteria
Inclusion Criteria:Patients eligible for the trial must comply with all of the following at randomization:• Age between 13 and 18 years for the group with conventional orthodontic appliances.This age group represents the majority of patients seeking orthodontic treatment and is homogeneous regarding occupational status (high-school and lyceum students in Greece).
Younger patients might present with cooperation problems.Good general health.Orthodontic fixed labial appliances on the maxillary and mandibular arch, brackets at least on 20 teeth for more than 4 months before enrollment and estimated duration of the treatment more than 1 month, bands on the first molars, extraction cases patients could be enrolled at least two months after the last extraction.Total initial VSCs levels above the baseline level of 150ppb.Exclusion Criteria:Patients will be excluded for any of the following reasons:Active cariesPeriodontitisDental fluorosis / dysplasia of the teethSyndromes, mental disabilities and craniofacial deformitiesSmoking or use of other tobacco productsAllergy to masticAntibiotics during the last 2 monthsChlorhexidine in the previous 3 weeksParticipation in other trials
Source: ClinicalTrials.gov (NCT05647369). StuddyBuddy aggregates publicly available trial information.
