HalitosisNCT06766097
Chios Mastic Toothpaste and Halitosis and Oral Hygiene in Orthodontic Patients
A study testing mastic toothpaste in people with Halitosis and Orthodontic Appliance Complication, run by University of Athens at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Halitosis, Orthodontic Appliance Complication
- What is being tested?
- mastic toothpaste
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteGreece
- Study dates
- 7 Jan 2025to 28 Feb 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- Allergy to mastic
- Antibiotics during the last 2 months
- Chlorhexidine in the previous 3 weeks
- Participation in other trials
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Greece1 site
School of Dentistry
Athens, Attica, 11527
Iosif Sifakakis, Associate Professor, +302107461337, isifak@dent.uoa.gr
Mairi Papadopoulou, Secretary, +302107461228, mapapad@dent.uoa.gr
About this study
Official title: The Effect of Chios' Mastic Toothpaste on Halitosis and Oral Hygiene in Orthodontic Patients: a Randomized Clinical Trial
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
- Being tested
- mastic toothpaste, Placebo toothpaste
- Keywords
- Halitosis, Mastic, Orthodontic appliance
- Medical subject headings
- Halitosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group Mastic toothpaste | Experimental | Experimental Group: patients, age 13-18, conventional brackets, Mastiha toothpaste 15 patients, with conventional brackets Receives: 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 Receives: Dietary Supplement: Placebo toothpaste |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start7 Jan 2025 (estimated)
- Primary completion31 Jan 2025 (estimated)
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HalitosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Iosif Sifakakis, University of Athens
- Investigators
- Iosif Sifakakis, Associate Professor, Study director, National and Kapodistrian Univrsity of Athens Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06766097
- Sponsor's protocol ID
- 613/09.11.2023
- Status last verified
- Jan 2025
- First submitted
- 3 Jan 2025
- Last updated
- 9 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40680773
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Chios' Mastic Toothpaste on Halitosis and Oral Hygiene in Orthodontic Patients: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06766097
- Acronym / sponsor ID
- 613/09.11.2023
- Conditions
- Halitosis, Orthodontic Appliance Complication
- Keywords
- Halitosis, Mastic, Orthodontic appliance
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of AthensUniversity, hospital or other
- Study start
- 7 Jan 2025 (estimated)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 9 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental group Mastic toothpaste | Experimental | Dietary Supplement: mastic toothpasteExperimental Group: patients, age 13-18, conventional brackets, Mastiha toothpaste 15 patients, with conventional brackets |
| Placebo control arm: placebo toothpaste | Placebo comparator | Dietary Supplement: Placebo toothpasteControl Group: patients, age 13-18, conventional brackets, Placebo toothpaste 15 patients, with conventional brackets |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- Active caries
- Periodontitis
- Dental fluorosis / dysplasia of the teeth
- Syndromes, mental disabilities and craniofacial deformities
- Smoking or use of other tobacco products
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mastic toothpasteAll 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 supplement | Experimental group Mastic toothpaste |
| Placebo toothpasteAll 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 supplement | Placebo control arm: placebo toothpaste |
Primary outcome
Modified plaque index (PI-M)
Time frame: 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.
Modified plaque index (PI-M)
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2025.
- Derived from this study: PubMed 40680773Alexiou 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.
Related trials for Halitosis
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Recruiting
The Effect of Regular Home Use of Dual-light Antibacterial Photodynamic Therapy (aPDT) or the Use of a Powered Toothbrush in Older Individuals With Periodontitis and Mild Cognitive Impairment.
Periodontal Diseases, Oral Halitosis
Active, not recruiting
Effects of Green Tea Mouthwash on Halitosis, Periodontal Health, and Stress in Orthodontic Patients
Halitosis, Periodontal Health
RecruitingPhase 2
Effectiveness of Aquamin® in Mitigating Halitosis
Healthy, Halitosis
Not yet recruiting
Effects of a 50+ Toothpaste on Halitosis and Oral Comfort in Healthy Adults
Oral Malodor (Halitosis), Oral Dryness
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Iosif Sifakakis, Associate Professor study director
National and Kapodistrian Univrsity of Athens Greece
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mastic toothpaste in people with Halitosis and Orthodontic Appliance Complication, run by University of Athens at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Iosif Sifakakis, Associate Professor (+302107461228, isifak@dent.uoa.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified plaque index (PI-M) (time frame: baseline - 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06766097, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2025.