Effects of Green Tea Mouthwash on Halitosis, Periodontal Health, and Stress in Orthodontic Patients

NCT07829224 | Active Not Recruiting

• 1 other identifier: USM/JEPeM/PP/25050413
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Halitosis; Periodontal Health; Orthodontic Treatment

Keywords

Green tea mouthwash; Fixed orthodontic appliances; Halitosis; Salivary cortisol; Oxidative stress; Periodontal health; Porphyromonas gingivalis

Outcome Measures

Primary Outcomes (1)

• 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)

  Baseline, 4 months, 5 months, and 6 months

Secondary Outcomes (4)

• Change in Salivary Cortisol Level

  Baseline, 4 months, 5 months, and 6 months

• Change in Malondialdehyde (MDA) Level

  Baseline, 4 months, 5 months, and 6 months

• Change in Salivary Total Antioxidant Capacity (TAC)

  Baseline, 4 months, 5 months, and 6 months

• Self-Perceived Halitosis, Oral and Dental Health, and Orthodontic Pain

  Day 0 and after 3 months

Study Arms (4)

Green Tea Mouthwash A

EXPERIMENTAL

Participants receive green tea mouthwash A during fixed orthodontic treatment

Other: Green Tea Mouthwash A

Green Tea Mouthwash B

EXPERIMENTAL

Participants receive green tea mouthwash B during fixed orthodontic treatment

Other: Green Tea Mouthwash B

Fluoride Mouthwash

ACTIVE COMPARATOR

Participants receive a fluoride-containing mouthwash during fixed orthodontic treatment

Other: Fluoride Mouthwash

Placebo

PLACEBO COMPARATOR

Participants receive normal saline mouthwash during fixed orthodontic treatment

Other: Normal Saline Mouthwash

Interventions

Green Tea Mouthwash A OTHER

Participants use Green Tea Mouthwash A during fixed orthodontic treatment according to the study protocol.

Green Tea Mouthwash A

Green Tea Mouthwash B OTHER

Participants use Green Tea Mouthwash B during fixed orthodontic treatment according to the study protocol.

Green Tea Mouthwash B

Fluoride Mouthwash OTHER

Participants use a fluoride-containing mouthwash during fixed orthodontic treatment according to the study protocol.

Fluoride Mouthwash

Normal Saline Mouthwash OTHER

Participants use normal saline as the placebo mouthwash during fixed orthodontic treatment according to the study protocol.

Placebo

Eligibility Criteria

• Age: 15 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• No craniofacial anomalies. Good oral hygiene according to the plaque index criterion stated in the study protocol.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universiti Sains Malaysia: lead

Study Sites (1)

Al-Hadi University, College of Dentistry, Dental Specialized Center

Baghdad, Aljadriya, 10011, Iraq

Location

MeSH Terms

Conditions

Halitosis

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Candidate

Model Details: 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.

Study Record Dates

• First Submitted: September 14, 2026
• First Posted: September 18, 2026
• Study Start: January 3, 2026
• Primary Completion (Estimated): December 20, 2026
• Study Completion (Estimated): December 20, 2026
• Last Updated: September 24, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)