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Chios Mastic Mouthwash and Halitosis and Oral Hygiene in Orthodontic Patients

NCT05647369 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-01-14

No results posted yet for this study

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 .

Conditions

  • Halitosis
  • Orthodontic Appliance Complication

Interventions

DIETARY_SUPPLEMENT

Mastic mouthwash

All 30 patients will be randomly assigned to either the mastic mouthwash group A (Art of Nature Mastiha Mouthwash, Mastihashop, Greece) (n = 15) or the placebo mouthwash group B (from the same manufacturer) (n = 15) (Table 1). All patients will be asked to use the mouthwash twice a day (10 ml of mouthwash / 2 times a day for 30 sec for 14 days, every morning and every night after brushing) and to maintain their usual oral hygiene routine. The measurements will be done in the morning and at least three hours after brushing and without the use of the mouthwash by the participant on the day of the assessments.

DIETARY_SUPPLEMENT

Placebo mouthwash

All 30 patients will be randomly assigned to either the mastic mouthwash group A (Art of Nature Mastiha Mouthwash, Mastihashop, Greece) (n = 15) or the placebo mouthwash group B (from the same manufacturer) (n = 15) (Table 1). All patients will be asked to use the mouthwash twice a day (10 ml of mouthwash / 2 times a day for 30 sec for 14 days, every morning and every night after brushing) and to maintain their usual oral hygiene routine. The measurements will be done in the morning and at least three hours after brushing and without the use of the mouthwash by the participant on the day of the assessments.

Sponsors & Collaborators

  • Iosif Sifakakis

    lead OTHER

Principal Investigators

  • Iosif Sifakakis, Assistant Professor · University of Athens

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-12-01
Primary Completion
2023-03-01
Completion
2023-03-01

Countries

  • Greece

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05647369 on ClinicalTrials.gov