Chios Mastic Toothpaste and Halitosis and Oral Hygiene in Orthodontic Patients

NCT06766097 | Not Yet Recruiting DMC

• 1 other identifier: 613/09.11.2023
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Halitosis; Orthodontic Appliance Complication

Keywords

Halitosis; Mastic; Orthodontic appliance

Outcome Measures

Primary Outcomes (2)

• Modified plaque index (PI-M)

  The Silness and Löe index (Silness and Löe, 1964) does not take into account the pattern of plaque accumulation in orthodontic patients. To overcome this problem, Williams et al. (1991) divided the tooth into mesial, distal, gingival, and incisal regions in relation to the bracket and scored plaque in each region using the four codes of the original index (0 to 3). The values are summed to obtain a total score, which ranges from 0 to 12 for each tooth. This modified index is recommended for patients with fixed orthodontic appliances because it acknowledges the usual effects of orthodontic appliances on plaque distribution and has much greater categorical discrimination.

  baseline - 2 weeks

• Modified plaque index (PI-M)

  The Silness and Löe index (Silness and Löe, 1964) does not take into account the pattern of plaque accumulation in orthodontic patients. To overcome this problem, Williams et al. (1991) divided the tooth into mesial, distal, gingival, and incisal regions in relation to the bracket and scored plaque in each region using the four codes of the original index (0 to 3). The values are summed to obtain a total score, which ranges from 0 to 12 for each tooth. This modified index is recommended for patients with fixed orthodontic appliances because it acknowledges the usual effects of orthodontic appliances on plaque distribution and has much greater categorical discrimination.

  2 weeks

Study Arms (2)

Experimental group Mastic toothpaste

EXPERIMENTAL

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

Dietary Supplement: mastic toothpaste

Placebo control arm: placebo toothpaste

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo toothpaste

Interventions

mastic toothpaste 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.

Experimental group Mastic toothpaste

Placebo toothpaste 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

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Athens: lead

Study Sites (1)

School of Dentistry

Athens, Attica, 11527, Greece

Location

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Halitosis

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Iosif Sifakakis, Associate Professor

  National and Kapodistrian Univrsity of Athens Greece

  STUDY DIRECTOR

Central Study Contacts

Iosif Sifakakis, Associate Professor

CONTACT

+302107461228; isifak@dent.uoa.gr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: January 3, 2025
• First Posted: January 9, 2025
• Study Start: January 7, 2025
• Primary Completion: January 31, 2025
• Study Completion: February 28, 2025
• Last Updated: January 9, 2025

Record last verified: 2025-01

Locations

GR (1)