An interventional study of Green Tea Mouthwash A and Green Tea Mouthwash B in Halitosis, Periodontal Health and Orthodontic Treatment, sponsored by Universiti Sains Malaysia. Active, not recruiting at 1 site in Iraq. Open to participants aged 15 Years to 25 Years. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by Universiti Sains Malaysia · Not applicable, Interventional, and Treatment
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.
93 studies on the registry are indexed under Halitosis; 17 are open to participants now.
This study's enrollment of 100 is above the median of 45 across 79 interventional studies indexed under Halitosis.
Browse Halitosis studies →Universiti Sains Malaysia is the lead sponsor of 177 studies on the registry; 51 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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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Participants receive green tea mouthwash A during fixed orthodontic treatment
Other: Green Tea Mouthwash A
Participants receive green tea mouthwash B during fixed orthodontic treatment
Other: Green Tea Mouthwash B
Participants receive a fluoride-containing mouthwash during fixed orthodontic treatment
Other: Fluoride Mouthwash
Participants receive normal saline mouthwash during fixed orthodontic treatment
Other: Normal Saline Mouthwash
Participants use Green Tea Mouthwash A during fixed orthodontic treatment according to the study protocol.
Participants use Green Tea Mouthwash B during fixed orthodontic treatment according to the study protocol.
Participants use a fluoride-containing mouthwash during fixed orthodontic treatment according to the study protocol.
Participants use normal saline as the placebo mouthwash during fixed orthodontic treatment according to the study protocol.
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)
Time frame: Baseline, 4 months, 5 months, and 6 months
Change in Salivary Cortisol Level
Salivary cortisol concentration is measured using the Cobas e411 system and reported in nmol/L
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Day 0 and after 3 months
Plan to share: 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.
No publications or documents are linked to this record.
Started Jan 2026 (actual). Primary completion is estimated for Dec 2026, 11 months after the start.
Of 35 non-industry interventional studies with no phase under Halitosis, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 18. This study's planned 11 months is close to that.
Counting every sponsor, half of 43 studies reached it within 10 months; a quarter within 3 and three quarters within 18.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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