Chios Mastic Toothpaste and Halitosis and Oral Hygiene in Orthodontic Patients

National and Kapodistrian University of Athens

Status: Not yet enrolling

Conditions: Halitosis; Orthodontic Appliance Complication

Treatments: Dietary Supplement: Placebo toothpaste; Dietary Supplement: mastic toothpaste

Study type: Interventional

Funder types: Other

Identifiers

NCT06766097

613/09.11.2023

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 13 to 18 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups, including a placebo group

Experimental group Mastic toothpaste

Experimental group

Description:

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

Treatment:

Dietary Supplement: mastic toothpaste

Placebo control arm: placebo toothpaste

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo toothpaste