Orthodontic Appliance ComplicationNCT07254819
Cotinus Coggygria Mouthwash and Halitosis and Oral Hygiene in Orthodontic Patients
A study testing Cotinus Coggygria mouthwash in people with Orthodontic Appliance Complication and Halitosis, run by University of Athens at 1 site in Greece.
Trial summary
The aim of this trial was to investigate the effect of Cotinus Coggygria mouthwash 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
- Orthodontic Appliance Complication, Halitosis
- What is being tested?
- Cotinus Coggygria mouthwash
- 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
- 3 Dec 2025to 17 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Cotinus Coggygria (Smoke tree)
- Antibiotics during the last 2 months
- Chlorhexidine or other mouthwash use in the previous 3 weeks
- Participation in other trials
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Cotinus Coggygria Mouthwash on Halitosis and Oral Hygiene in Orthodontic Patients: a Randomized Clinical Trial
The aim of this trial was to investigate the effect of Cotinus Coggygria mouthwash 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
- Orthodontic Appliance Complication, Halitosis
- Being tested
- Cotinus Coggygria mouthwash, Placebo mouthwash
- Keywords
- halitosis, Cotinus Coggygria, 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.
Cotinus Coggygria mouthwashDietary supplement
All 30 patients will be randomly assigned to either the Cotinus Coggygria mouthwash group A (Natural Smoke Tree Hydrolina, Ina Essentials) (n = 15) or the placebo Mouthwash group B (from the same manufacturer) (n = 15). All patients will be asked to use the mouthwash twice 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 mouthwash by the participant on the day of the assessments.
Placebo mouthwashDietary supplement
All 30 patients will be randomly assigned to either the group A (Cotinus Coggygria mouthwash ) (n = 15) or the placebo Mouthwash group B (from the same manufacturer) (n = 15). All patients will be asked to use the mouthwash twice 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 mouthwash by the participant on the day of the assessments.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Experimental group Cotinus Coggygria mouthwash | Experimental | Experimental Group: patients, age 13-18, conventional brackets, Cotinus Coggygria mouthwash 15 patients, with conventional brackets Receives: Dietary Supplement: Cotinus Coggygria mouthwash |
| Placebo control arm: placebo mouthwash | Placebo comparator | Control Group: patients, age 13-18, conventional brackets, Placebo mouthwash 15 patients, with conventional brackets Receives: Dietary Supplement: Placebo mouthwash |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hydrogen Sulfide (H2S) Levels
Halitosis can be assessed using Gas chromatography that offers highly accurate qualitative and quantitative analysis of the individual VSCs, making it the preferred method for comprehensive diagnostic evaluation in both routine and complex cases. Halitosis is typically defined by a total VSCs concentration of ⩾150 ppb, a threshold supported across multiple clinical studies.
The malodor results from the degradation of organic components in saliva, leading to the production of volatile sulfur compounds (VSCs), including hydrogen sulfide (H2S). H2S has been linked to increased gingival cell apoptosis and susceptibility to periodontitis.
Measured: baseline
Hydrogen Sulfide (H2S) Levels
Halitosis can be assessed using Gas chromatography that offers highly accurate qualitative and quantitative analysis of the individual VSCs, making it the preferred method for comprehensive diagnostic evaluation in both routine and complex cases. Halitosis is typically defined by a total VSCs concentration of ⩾150 ppb, a threshold supported across multiple clinical studies.
The malodor results from the degradation of organic components in saliva, leading to the production of volatile sulfur compounds (VSCs), including hydrogen sulfide (H2S). H2S has been linked to increased gingival cell apoptosis and susceptibility to periodontitis.
Measured: 2 weeks
Secondary outcomes (8)
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
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
Gingival Index (GI)
The original Silness and Löe Plaque Index (1964) was not designed for orthodontic patients. The present study adopted a widely used modification of this index, in which the teeth are divided into incisal, distal, and mesial areas relative to the bracket, and plaque is graded in each area using values from 0 to 3.
Measured: baseline
Gingival Index (GI)
The original Silness and Löe Plaque Index (1964) was not designed for orthodontic patients. The present study adopted a widely used modification of this index, in which the teeth are divided into incisal, distal, and mesial areas relative to the bracket, and plaque is graded in each area using values from 0 to 3.
Measured: 2 weeks
Dimethyl Sulfide [ (CH3)2S] Levels
Halitosis can be assessed using Gas chromatography that offers highly accurate qualitative and quantitative analysis of the individual VSCs, making it the preferred method for comprehensive diagnostic evaluation in both routine and complex cases. Halitosis is typically defined by a total VSCs concentration of ⩾150 ppb, a threshold supported across multiple clinical studies. The malodor results from the degradation of organic components in saliva, leading to the production of volatile sulfur compounds (VSCs), including Dimethyl Sulfide [ (CH3)2S] Levels.
Measured: baseline
Dimethyl Sulfide [ (CH3)2S] Levels
Halitosis can be assessed using Gas chromatography that offers highly accurate qualitative and quantitative analysis of the individual VSCs, making it the preferred method for comprehensive diagnostic evaluation in both routine and complex cases. Halitosis is typically defined by a total VSCs concentration of ⩾150 ppb, a threshold supported across multiple clinical studies. The malodor results from the degradation of organic components in saliva, leading to the production of volatile sulfur compounds (VSCs), including Dimethyl Sulfide [ (CH3)2S] Levels.
Measured: 2 weeks
Methyl-mercaptan (CH3SH) Levels
Halitosis can be assessed using Gas chromatography that offers highly accurate qualitative and quantitative analysis of the individual VSCs, making it the preferred method for comprehensive diagnostic evaluation in both routine and complex cases. Halitosis is typically defined by a total VSCs concentration of ⩾150 ppb, a threshold supported across multiple clinical studies. The malodor results from the degradation of organic components in saliva, leading to the production of volatile sulfur compounds (VSCs), including Methyl-mercaptan (CH3SH) levels.
Measured: baseline
Methyl-mercaptan (CH3SH) Levels
Halitosis can be assessed using Gas chromatography that offers highly accurate qualitative and quantitative analysis of the individual VSCs, making it the preferred method for comprehensive diagnostic evaluation in both routine and complex cases. Halitosis is typically defined by a total VSCs concentration of ⩾150 ppb, a threshold supported across multiple clinical studies. The malodor results from the degradation of organic components in saliva, leading to the production of volatile sulfur compounds (VSCs), including Methyl-mercaptan (CH3SH) levels.
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 posted28 Nov 2025
- Study start3 Dec 2025
- Primary completion17 Dec 2025
- Study completion17 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthodontic Appliance ComplicationStudies 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 Cotinus Coggygria mouthwash or placebo mouthwash.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
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 University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07254819
- Sponsor's protocol ID
- 680/03.02.2025
- Status last verified
- Dec 2025
- First submitted
- 19 Nov 2025
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cotinus Coggygria Mouthwash on Halitosis and Oral Hygiene in Orthodontic Patients: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07254819
- Acronym / sponsor ID
- 680/03.02.2025
- Conditions
- Orthodontic Appliance Complication, Halitosis
- Keywords
- halitosis, Cotinus Coggygria, Orthodontic Appliance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of AthensUniversity, hospital or other
- Study start
- 3 Dec 2025 (actual)
- Primary completion
- 17 Dec 2025 (actual)
- Study completion
- 17 Dec 2025 (actual)
- First posted
- 28 Nov 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 Cotinus Coggygria mouthwash 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
- Triple blind (participant, investigator, outcomes assessor)
- 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 Cotinus Coggygria mouthwash or placebo mouthwash.
| Arm | Type | Receives |
|---|---|---|
| Experimental: Experimental group Cotinus Coggygria mouthwash | Experimental | Dietary Supplement: Cotinus Coggygria mouthwashExperimental Group: patients, age 13-18, conventional brackets, Cotinus Coggygria mouthwash 15 patients, with conventional brackets |
| Placebo control arm: placebo mouthwash | Placebo comparator | Dietary Supplement: Placebo mouthwashControl Group: patients, age 13-18, conventional brackets, Placebo mouthwash 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 |
|---|---|---|
| Cotinus Coggygria mouthwashAll 30 patients will be randomly assigned to either the Cotinus Coggygria mouthwash group A (Natural Smoke Tree Hydrolina, Ina Essentials) (n = 15) or the placebo Mouthwash group B (from the same manufacturer) (n = 15). All patients will be asked to use the mouthwash twice 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 mouthwash by the participant on the day of the assessments. | Dietary supplement | Experimental: Experimental group Cotinus Coggygria mouthwash |
| Placebo mouthwashAll 30 patients will be randomly assigned to either the group A (Cotinus Coggygria mouthwash ) (n = 15) or the placebo Mouthwash group B (from the same manufacturer) (n = 15). All patients will be asked to use the mouthwash twice 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 mouthwash by the participant on the day of the assessments. | Dietary supplement | Placebo control arm: placebo mouthwash |
Primary outcome
Hydrogen Sulfide (H2S) Levels
Time frame: baseline
Halitosis can be assessed using Gas chromatography that offers highly accurate qualitative and quantitative analysis of the individual VSCs, making it the preferred method for comprehensive diagnostic evaluation in both routine and complex cases. Halitosis is typically defined by a total VSCs concentration of ⩾150 ppb, a threshold supported across multiple clinical studies. The malodor results from the degradation of organic components in saliva, leading to the production of volatile sulfur compounds (VSCs), including hydrogen sulfide (H2S). H2S has been linked to increased gingival cell apoptosis and susceptibility to periodontitis.
Hydrogen Sulfide (H2S) Levels
Time frame: 2 weeks
Halitosis can be assessed using Gas chromatography that offers highly accurate qualitative and quantitative analysis of the individual VSCs, making it the preferred method for comprehensive diagnostic evaluation in both routine and complex cases. Halitosis is typically defined by a total VSCs concentration of ⩾150 ppb, a threshold supported across multiple clinical studies. The malodor results from the degradation of organic components in saliva, leading to the production of volatile sulfur compounds (VSCs), including hydrogen sulfide (H2S). H2S has been linked to increased gingival cell apoptosis and susceptibility to periodontitis.
8 secondary outcomes
Modified plaque index (PI-M)
Time frame: baseline
Modified plaque index (PI-M)
Time frame: 2 weeks
Gingival Index (GI)
Time frame: baseline
Gingival Index (GI)
Time frame: 2 weeks
Dimethyl Sulfide [ (CH3)2S] Levels
Time frame: baseline
Dimethyl Sulfide [ (CH3)2S] Levels
Time frame: 2 weeks
Methyl-mercaptan (CH3SH) Levels
Time frame: baseline
Methyl-mercaptan (CH3SH) Levels
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Iosif Sifakakis, Associate Professor study director
National and Kapodistrian University of Athens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cotinus Coggygria mouthwash in people with Orthodontic Appliance Complication and Halitosis, 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: finished, as of the sponsor's last update on 18 Dec 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hydrogen Sulfide (H2S) Levels (time frame: baseline). 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?
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 18 Dec 2025.