HalitosisNCT07829224
Effects of Green Tea Mouthwash on Halitosis, Periodontal Health, and Stress in Orthodontic Patients
A study testing Green Tea Mouthwash A, Green Tea Mouthwash B and Fluoride Mouthwash in people with Halitosis and Periodontal Health, run by Universiti Sains Malaysia at 1 site in Iraq.
Trial summary
This randomized, double-blind, four-arm clinical trial evaluates the effects of green tea mouthwash on halitosis, periodontal health, salivary stress biomarkers, and oxidative stress in patients undergoing fixed orthodontic treatment. Read more about this study
- Who is it for?
- Ages 15 to 25 years
- Conditions the study is for
- Halitosis, Periodontal Health, Orthodontic Treatment
- What is being tested?
- Green Tea Mouthwash A, Green Tea Mouthwash B and Fluoride Mouthwash
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteIraq
- Study dates
- 3 Jan 2026to 20 Dec 2026
- 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 15 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Inclusion Criteria: Age 15-25 years. Patients requiring or wearing upper and lower fixed orthodontic appliances in the initial phase of treatment.
No craniofacial anomalies. Good oral hygiene according to the plaque index criterion stated in the study protocol.
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Exclusion Criteria: Current use of antibiotics or medications that may affect oral microbiota.
Extensive dental caries. Severe periodontal disease. Mouth breathing. Systemic conditions. Pregnancy or breastfeeding. Unable to adhere to the study protocol or attend follow-up appointments.
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Trial locations and contacts
1 site in 1 country.
Iraq1 site
Al-Hadi University, College of Dentistry, Dental Specialized Center
Baghdad, Aljadriya, 10011
About this study
Official title: The Role of Green Tea Mouthwash in Managing Halitosis, Periodontal Health and Stress: A Comprehensive Study in Orthodontic Patients
This randomized, double-blind, four-arm clinical trial evaluates the effects of green tea mouthwash on halitosis, periodontal health, salivary stress biomarkers, and oxidative stress in patients undergoing fixed orthodontic treatment. Participants aged 15-25 years are assigned to one of four mouthwash groups: two green tea mouthwashes, a fluoride mouthwash, or normal saline. Outcomes are assessed before treatment and during follow-up using halitosis measurements, periodontal assessments, salivary biomarkers, and microbiological analysis.
- Conditions
- Halitosis, Periodontal Health, Orthodontic Treatment
- Being tested
- Green Tea Mouthwash A, Green Tea Mouthwash B, Fluoride Mouthwash, Normal Saline Mouthwash
- Keywords
- Green tea mouthwash, Fixed orthodontic appliances, Halitosis, Salivary cortisol, Oxidative stress, Periodontal health, Porphyromonas gingivalis
- Medical subject headings
- Halitosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Green Tea Mouthwash AOther
Participants use Green Tea Mouthwash A during fixed orthodontic treatment according to the study protocol.
Green Tea Mouthwash BOther
Participants use Green Tea Mouthwash B during fixed orthodontic treatment according to the study protocol.
Fluoride MouthwashOther
Participants use a fluoride-containing mouthwash during fixed orthodontic treatment according to the study protocol.
Normal Saline MouthwashOther
Participants use normal saline as the placebo mouthwash during fixed orthodontic treatment according to the study protocol.
| Study group | Role | What they receive |
|---|---|---|
| Green Tea Mouthwash A | Experimental | Participants receive green tea mouthwash A during fixed orthodontic treatment Receives: Other: Green Tea Mouthwash A |
| Green Tea Mouthwash B | Experimental | Participants receive green tea mouthwash B during fixed orthodontic treatment Receives: Other: Green Tea Mouthwash B |
| Fluoride Mouthwash | Active comparator | Participants receive a fluoride-containing mouthwash during fixed orthodontic treatment Receives: Other: Fluoride Mouthwash |
| Placebo | Placebo comparator | Participants receive normal saline mouthwash during fixed orthodontic treatment Receives: Other: Normal Saline Mouthwash |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Halitosis Level Measured by Halimeter
Halitosis is assessed using a Halimeter. Two readings are obtained at each assessment and averaged. Results are recorded in parts per billion (ppb)
Measured: Baseline, 4 months, 5 months, and 6 months
Secondary outcomes (4)
Change in Salivary Cortisol Level
Salivary cortisol concentration is measured using the Cobas e411 system and reported in nmol/L
Measured: Baseline, 4 months, 5 months, and 6 months
Change in Malondialdehyde (MDA) Level
Salivary malondialdehyde concentration is measured using an ELISA assay and reported according to the assay units.
Measured: Baseline, 4 months, 5 months, and 6 months
Change in Salivary Total Antioxidant Capacity (TAC)
Salivary total antioxidant capacity is measured using a colorimetric assay as an indicator of antioxidant status.
Measured: Baseline, 4 months, 5 months, and 6 months
Self-Perceived Halitosis, Oral and Dental Health, and Orthodontic Pain
Participants complete questionnaire items adapted from a validated questionnaire to assess self-perceived halitosis and oral and dental health during orthodontic treatment. These responses are analyzed individually and no total questionnaire score is calculated. Orthodontic pain is assessed using a Visual Analog Scale from 0 to 10, where 0 indicates no pain and 10 indicates the worst possible pain; higher scores indicate greater pain.
Measured: Day 0 and after 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2026
- Study start3 Jan 2026
- Primary completion20 Dec 2026 (estimated)
- Study completion20 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned in a 1:1:1:1 ratio to one of four parallel mouthwash groups: two green tea mouthwashes, fluoride mouthwash, or normal saline.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Sains Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hind Hadi Enad, Universiti Sains Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07829224
- Sponsor's protocol ID
- USM/JEPeM/PP/25050413
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the approved study protocol requires participant data to remain anonymized, securely stored, and accessible only to the research team.
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Green Tea Mouthwash in Managing Halitosis, Periodontal Health and Stress: A Comprehensive Study in Orthodontic Patients
- ClinicalTrials.gov ID
- NCT07829224
- Acronym / sponsor ID
- USM/JEPeM/PP/25050413
- Conditions
- Halitosis, Periodontal Health, Orthodontic Treatment
- Keywords
- Green tea mouthwash, Fixed orthodontic appliances, Halitosis, Salivary cortisol, Oxidative stress, Periodontal health, Porphyromonas gingivalis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Universiti Sains MalaysiaUniversity, hospital or other
- Study start
- 3 Jan 2026 (actual)
- Primary completion
- 20 Dec 2026 (estimated)
- Study completion
- 20 Dec 2026 (estimated)
- First posted
- 18 Sep 2026 (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.
This randomized, double-blind, four-arm clinical trial evaluates the effects of green tea mouthwash on halitosis, periodontal health, salivary stress biomarkers, and oxidative stress in patients undergoing fixed orthodontic treatment. Participants aged 15-25 years are assigned to one of four mouthwash groups: two green tea mouthwashes, a fluoride mouthwash, or normal saline. Outcomes are assessed before treatment and during follow-up using halitosis measurements, periodontal assessments, salivary biomarkers, and microbiological analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- Participants are randomly assigned in a 1:1:1:1 ratio to one of four parallel mouthwash groups: two green tea mouthwashes, fluoride mouthwash, or normal saline.
| Arm | Type | Receives |
|---|---|---|
| Green Tea Mouthwash A | Experimental | Other: Green Tea Mouthwash AParticipants receive green tea mouthwash A during fixed orthodontic treatment |
| Green Tea Mouthwash B | Experimental | Other: Green Tea Mouthwash BParticipants receive green tea mouthwash B during fixed orthodontic treatment |
| Fluoride Mouthwash | Active comparator | Other: Fluoride MouthwashParticipants receive a fluoride-containing mouthwash during fixed orthodontic treatment |
| Placebo | Placebo comparator | Other: Normal Saline MouthwashParticipants receive normal saline mouthwash during fixed orthodontic treatment |
Who may qualify
- Ages
- 15 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
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 |
|---|---|---|
| Green Tea Mouthwash AParticipants use Green Tea Mouthwash A during fixed orthodontic treatment according to the study protocol. | Other | Green Tea Mouthwash A |
| Green Tea Mouthwash BParticipants use Green Tea Mouthwash B during fixed orthodontic treatment according to the study protocol. | Other | Green Tea Mouthwash B |
| Fluoride MouthwashParticipants use a fluoride-containing mouthwash during fixed orthodontic treatment according to the study protocol. | Other | Fluoride Mouthwash |
| Normal Saline MouthwashParticipants use normal saline as the placebo mouthwash during fixed orthodontic treatment according to the study protocol. | Other | Placebo |
Primary outcome
Change in Halitosis Level Measured by Halimeter
Time frame: Baseline, 4 months, 5 months, and 6 months
Halitosis is assessed using a Halimeter. Two readings are obtained at each assessment and averaged. Results are recorded in parts per billion (ppb)
4 secondary outcomes
Change in Salivary Cortisol Level
Time frame: Baseline, 4 months, 5 months, and 6 months
Change in Malondialdehyde (MDA) Level
Time frame: Baseline, 4 months, 5 months, and 6 months
Change in Salivary Total Antioxidant Capacity (TAC)
Time frame: Baseline, 4 months, 5 months, and 6 months
Self-Perceived Halitosis, Oral and Dental Health, and Orthodontic Pain
Time frame: Day 0 and after 3 months
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 24 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the approved study protocol requires participant data to remain anonymized, securely stored, and accessible only to the research team.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Green Tea Mouthwash A, Green Tea Mouthwash B and Fluoride Mouthwash in people with Halitosis and Periodontal Health, run by Universiti Sains Malaysia at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: under way, not looking for participants, as of the sponsor's last update on 24 Sep 2026. 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 Iraq. 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?
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?
Change in Halitosis Level Measured by Halimeter (time frame: Baseline, 4 months, 5 months, and 6 months). 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 24 Sep 2026.