Chios Mastic Mouthwash and Halitosis and Oral Hygiene in Orthodontic Patients

NCT ID: NCT05647369

Last Updated: 2025-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-01
• Study Completion Date: 2023-03-01

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).

Conditions

Halitosis; Orthodontic Appliance Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Experimental: Group 1

Experimental: Experimental group 1: patients, age 13-18, conventional brackets, Mastic mouthwash 15 patients, age 13-18,with conventional brackets,will get Mastic mouthwash

Group Type: EXPERIMENTAL

Mastic mouthwash

Intervention Type: DIETARY_SUPPLEMENT

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.

Control group: Group 2

Control group: Group 2 patients, age 13-18, conventional brackets, placebo mouthwash 15 patients, age 13-18,with conventional brackets,will get placebo mouthwash

Group Type: PLACEBO_COMPARATOR

Placebo mouthwash

Intervention Type: DIETARY_SUPPLEMENT

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Iosif Sifakakis

OTHER

Sponsor Role: lead

Responsible Party

Iosif Sifakakis

Iosif Sifakakis, assistant professor, National and Kapodistrian University of Athens

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Iosif Sifakakis, Assistant Professor

Role: PRINCIPAL_INVESTIGATOR

University of Athens

Locations

National and Kapodistrian University of Athens, School of Dentistry, Departments of Orthodontics

Athens, Attica, Greece

Countries

Greece

References

Tsironi K, Mylonopoulou IM, Pandis N, Vassilopoulos S, Sifakakis I, Papaioannou W. The effect of mastic mouthwash on halitosis and oral hygiene in orthodontic patients: a randomized clinical trial. Eur J Orthod. 2023 Nov 30;45(6):781-787. doi: 10.1093/ejo/cjad036.

Reference Type: DERIVED

PMID: 37503575 (View on PubMed)

Other Identifiers

461/12.03.2021

Identifier Type: -

Identifier Source: org_study_id