Clinical trial NCT05647369: Chios Mastic Mouthwash and Halitosis and Oral Hygiene in Orthodontic Patients
Official title: The Effect of Chios Mastic Mouthwash on Halitosis and Oral Hygiene in Orthodontic Patients: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Halitosis
Orthodontic Appliance Complication
Keywords: Halitosis
Mastic
Orthodontic appliance
Lead sponsor: University of Athens
Sponsor class: OTHER
First posted: 2022-12-12
Enrollment: 30
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This trial is designed as a prospective, randomized, placebo-controlled, double (investigator and patient) blinded, with two parallel groups and an equal allocation ratio in all groups. In this study, the intervention consists of delivery of mastic mouthwash or placebo lozenges.
Primary purpose: PREVENTION

Brief 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 .

Detailed 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).

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 caries
* Periodontitis
* Dental fluorosis / dysplasia of the teeth
* Syndromes, mental disabilities and craniofacial deformities
* Smoking or use of other tobacco products
* Allergy to mastic
* Antibiotics during the last 2 months
* Chlorhexidine in the previous 3 weeks
* Participation in other trials

Primary outcomes:
measure: Modified plaque index (PI-M)
timeFrame: baseline-2 weeks
measure: Gingival index (GI)
timeFrame: baseline-2 weeks
measure: VSCs levels {hydrogen sulfide (H2S), methyl-mercaptan (CH3SH) and dimethyl sulfide [(CH3)2S].
timeFrame: baseline-2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Athens
country: Greece
facility: National and Kapodistrian University of Athens, School of Dentistry, Departments of Orthodontics
state: Attiki
Study officials:
affiliation: University of Athens
name: Iosif Sifakakis, Assistant Professor
role: PRINCIPAL_INVESTIGATOR
References: