Halitosis, Orthodontic Appliance Complication
Conditions
Keywords
Halitosis, Mastic, Orthodontic appliance
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.
Interventions
DIETARY_SUPPLEMENTmastic 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.
DIETARY_SUPPLEMENTPlacebo 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.
Sponsors
University of Athens
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
13 Years to 18 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Modified plaque index (PI-M) | baseline - 2 weeks | 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. |
Countries
Greece
Contacts
Primary ContactIosif Sifakakis, Associate Professor
Outcome results
None listed