NCT06766097 - Chios Mastic Toothpaste and Halitosis and Oral Hygiene in Orthodontic Patients | Crick

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

30

Conditions

Halitosis Orthodontic Appliance Complication

Interventions

mastic toothpasteDIETARY_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 toothpasteDIETARY_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.

Eligibility

Sex: ALLMin age: 13 YearsMax age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

School of Dentistry

Athens, Attica, Greece

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 2 weeks

Central Contacts

Iosif Sifakakis, Associate Professor

CONTACT

+302107461228 isifak@dent.uoa.gr