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Not yet recruiting NCT06766097

Chios Mastic Toothpaste and Halitosis and Oral Hygiene in Orthodontic Patients

No phase Interventional Halitosis Orthodontic Appliance Complication

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: mastic toothpaste, Placebo toothpaste.
Who it may be relevant to
Registry conditions: Halitosis, Orthodontic Appliance Complication. Basic parameters: 13 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Greece
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

The Effect of Chios' Mastic Toothpaste on Halitosis and Oral Hygiene in Orthodontic Patients: a Randomized Clinical Trial

Overview

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.

Interventions

  • Dietary supplement 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 t
  • 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 t

Primary outcome measures

  • Modified plaque index (PI-M) [Time frame: baseline - 2 weeks]
  • Modified plaque index (PI-M) [Time frame: 2 weeks]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Prevention

Study locations

Greece · 1 center
  • School of Dentistry — Athens

Publications

  • Alexiou A, Mylonopoulou IM, Papageorgiou S, Papaioannou W, Sifakakis I. The effect of Chios mastic toothpaste on halitosis and oral hygiene in orthodontic patients: a randomized clinical trial. J Breath Res. 2025 Jul 30;19(4). doi: 10.1088/1752-7163/adf1bf. PMID 40680773

Identifiers

NCT: NCT06766097 · 613/09.11.2023

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗