An interventional study of mastic toothpaste and Placebo toothpaste in Halitosis and Orthodontic Appliance Complication, sponsored by University of Athens. Not yet recruiting at 1 site in Greece. Open to participants aged 13 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-09.
Sponsored by University of Athens · Not applicable, Interventional, and Prevention
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.
93 studies on the registry are indexed under Halitosis; 17 are open to participants now.
This study's planned enrollment of 30 is below the median of 45 across 79 interventional studies indexed under Halitosis.
Browse Halitosis studies →University of Athens is the lead sponsor of 139 studies on the registry; 19 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients eligible for the trial must comply with all of the following at randomization:
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.
Exclusion Criteria:
Patients will be excluded for any of the following reasons:
Experimental Group: patients, age 13-18, conventional brackets, Mastiha toothpaste 15 patients, with conventional brackets
Dietary Supplement: mastic toothpaste
Control Group: patients, age 13-18, conventional brackets, Placebo toothpaste 15 patients, with conventional brackets
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 the assessments.
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.
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
This study is not yet recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.