Halitosis, Periodontal Health, Orthodontic Treatment
Conditions
Keywords
Green tea mouthwash, Fixed orthodontic appliances, Halitosis, Salivary cortisol, Oxidative stress, Periodontal health, Porphyromonas gingivalis
Brief 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. 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.
Interventions
OTHERGreen Tea Mouthwash A
Participants use Green Tea Mouthwash A during fixed orthodontic treatment according to the study protocol.
OTHERGreen Tea Mouthwash B
Participants use Green Tea Mouthwash B during fixed orthodontic treatment according to the study protocol.
OTHERFluoride Mouthwash
Participants use a fluoride-containing mouthwash during fixed orthodontic treatment according to the study protocol.
OTHERNormal Saline Mouthwash
Participants use normal saline as the placebo mouthwash during fixed orthodontic treatment according to the study protocol.
Sponsors
Universiti Sains Malaysia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participants and outcome assessors are blinded to group allocation. Mouthwashes are provided in opaque bottles, and laboratory analyses are performed without knowledge of treatment allocation.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
15 Years to 25 Years
Healthy volunteers
No
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. \-
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. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Halitosis Level Measured by Halimeter | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Salivary Cortisol Level | Baseline, 4 months, 5 months, and 6 months | Salivary cortisol concentration is measured using the Cobas e411 system and reported in nmol/L |
| Change in Malondialdehyde (MDA) Level | Baseline, 4 months, 5 months, and 6 months | Salivary malondialdehyde concentration is measured using an ELISA assay and reported according to the assay units. |
| Change in Salivary Total Antioxidant Capacity (TAC) | Baseline, 4 months, 5 months, and 6 months | Salivary total antioxidant capacity is measured using a colorimetric assay as an indicator of antioxidant status. |
| Self-Perceived Halitosis, Oral and Dental Health, and Orthodontic Pain | Day 0 and after 3 months | 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. |
Countries
Iraq
Outcome results
None listed