Chios Mastic Toothpaste and Halitosis and Oral Hygiene in Orthodontic Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-07

Study Completion Date

2025-02-28

Brief Summary

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The aim of this trial was to investigate the effect of mastic toothpaste on halitosis using as proxy the levels of the Volatile Sulfur Compounds (VSCs), and the effect on plaque and gingival indices in adolescents undergoing orthodontic treatment with fixed conventional labial appliances.

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Detailed Description

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Conditions

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Halitosis Orthodontic Appliance Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This trial is designed as a prospective, randomized, placebo-controlled, double (investigator and patient) blinded study, with two parallel groups and an equal allocation ratio in all groups. In this study, the intervention consists of delivery of mastic toothpaste or placebo lozenges.

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

All patients will be allocated at a 1:1 ratio between group A (mastic group) and group B (placebo group), for each sex separately using stratified randomization. Two random sequences of 15 letters (A or B) will be obtained from www.random.org (List Randomizer service), one for males and one for females. Those letters were written on paper and then sealed in opaque envelopes, sequentially numbered from M1 to M15 for males and from F1 to F15 for females respectively. All envelopes were sealed, numbered and stored in a drawer by a person not involved in the study. Every patient enrolled in the study will receive an envelope in a numerical order and their name was written on the envelope. Informed consent will be obtained from parents / legal guardians and written consent upon information and prior to the randomization or application of any procedure obtained from the patients.

Study Groups

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Experimental group Mastic toothpaste

Experimental Group: patients, age 13-18, conventional brackets, Mastiha toothpaste 15 patients, with conventional brackets

Group Type EXPERIMENTAL

mastic toothpaste

Intervention Type DIETARY_SUPPLEMENT

All 30 patients will be randomly assigned to either the mastic toothpaste group A (Mastiha Toothpaste Gingivaction, Mastihashop, Greece) (n = 15) or the placebo Toothpaste group B (from the same manufacturer) (n = 15). All patients will be asked to use the toothpaste triple a day for 14 days 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 toothpaste by the participant on the day of the assessments.

Placebo control arm: placebo toothpaste

Control Group: patients, age 13-18, conventional brackets, Placebo toothpaste 15 patients, with conventional brackets

Group Type PLACEBO_COMPARATOR

Placebo toothpaste

Intervention Type DIETARY_SUPPLEMENT

All 30 patients will be randomly assigned to either the mastic toothpaste group A (Mastiha Toothpaste Gingivaction, Mastihashop, Greece) (n = 15) or the placebo Toothpaste group B (from the same manufacturer) (n = 15). All patients will be asked to use the toothpaste triple a day for 14 days 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 toothpaste by the participant on the day of the assessments.

Interventions

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mastic toothpaste

All 30 patients will be randomly assigned to either the mastic toothpaste group A (Mastiha Toothpaste Gingivaction, Mastihashop, Greece) (n = 15) or the placebo Toothpaste group B (from the same manufacturer) (n = 15). All patients will be asked to use the toothpaste triple a day for 14 days 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 toothpaste by the participant on the day of the assessments.

Intervention Type DIETARY_SUPPLEMENT

Placebo toothpaste

All 30 patients will be randomly assigned to either the mastic toothpaste group A (Mastiha Toothpaste Gingivaction, Mastihashop, Greece) (n = 15) or the placebo Toothpaste group B (from the same manufacturer) (n = 15). All patients will be asked to use the toothpaste triple a day for 14 days 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 toothpaste by the participant on the day of the assessments.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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