NCT07364565

Brief Summary

The goal of this clinical trial is to to evaluate the antiplaque and antigingivitis effect of pure green tea mouthwash compared to placebo and essential oils mouthwashes in healthy patients. The main questions it aims to answer are:

  • Does pure green tea mouthwash effectively reduce dental plaque?
  • Does pure green tea mouthwash reduce gingival inflammation? Researchers will compare pure green tea mouthwash to Listerine Total Care, Listerine Green Tea, and placebo to see if there is a difference in plaque accumulation and gum inflammation reduction. Participants will be prohibited from using any sort of oral hygiene parctice for the whole study period (3 weeks). Instead, they will rinse with 10 ml of their assigned mouthwash twice daily for 30 seconds. Plaque index, gingival index, and staining index will be examined at multiple intervals and participants will rate their sense of oral freshness and good breath.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
7mo left

Started Dec 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress43%
Dec 2025Dec 2026

Study Start

First participant enrolled

December 1, 2025

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

December 29, 2025

Completed
25 days until next milestone

First Posted

Study publicly available on registry

January 23, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

January 23, 2026

Status Verified

January 1, 2026

Enrollment Period

1 year

First QC Date

December 29, 2025

Last Update Submit

January 21, 2026

Conditions

Keywords

Green teaGingival inflammationPlaque indexEssential oilsMouthwashBleeding on probingCamellia sinensisHerbal medicinePeriodontal health

Outcome Measures

Primary Outcomes (1)

  • Turesky modification of the Quigley-Hein plaque index (TM-QHPI)

    will be recorded at six aspects on each tooth (mesialbuccal, midbuccal, distobuccal, mesiolingual, midlingual, and distolingual). 0: No plaque. 1. Separate flecks of plaque at the gumline (cervical margin). 2. A thin, continuous band (up to 1 mm) at the gumline. 3. A band wider than 1 mm but covering less than one-third of the tooth crown. 4. Plaque covering one-third to two-thirds of the crown. 5. Plaque covering two-thirds or more of the crown.

    On days 0, 7, 14, and 21

Secondary Outcomes (3)

  • Gingival Index (GI)

    On days 0, 7, 14, and 21

  • The Discoloration Index (DI)

    On days 0, 7, 14, and 21

  • Patient-reported outcome

    On days 7, 14, and 21

Study Arms (4)

Pure Green Tea Mouthwash

EXPERIMENTAL

Participants in this group will use a mouthwash prepared from pure green tea extract. The solution will be brewed by infusing 1 g of green tea leaves in 100 ml of boiling deionized water for 20 minutes, cooled, filtered, and stored in brown glass bottles.

Drug: Pure Green Tea Mouthwash

Listerine Total Care Mouthwash

ACTIVE COMPARATOR

Participants in this group will use Listerine Total Care essential oils mouthwash, containing eucalyptol, menthol, methyl salicylate, and thymol.

Drug: Listerine Total Care Mouthwash

Listerine Green Tea Mouthwash

ACTIVE COMPARATOR

Participants will use Listerine Green Tea mouthwash, an essential oil-based product enhanced with green tea extract.

Drug: Listerine Green Tea Mouthwash

Placebo Mouthwash

PLACEBO COMPARATOR

The solution contains only water and additive flavor with no active anti-inflammatory ingredients.

Other: Placebo Mouthwash

Interventions

Participants will rinse with 10 ml of a placebo solution consisting of pure water with a flavored additive to mimic taste and color. They should not use any form of oral hygiene during the study period. The solution contains no active anti-inflammatory ingredients. The placebo serves to determine baseline changes in plaque and gingivitis without active intervention.

Placebo Mouthwash

Participants in this group will use a mouthwash prepared from pure green tea extract. The solution will be brewed by infusing 1 g of green tea leaves in 100 ml of boiling deionized water for 20 minutes, cooled, filtered, and stored in brown glass bottles. Participants will rinse with 10 ml of the mouthwash twice daily for 30 seconds over 3 weeks. They should not use any form of oral hygiene during the study period.

Pure Green Tea Mouthwash

Participants in this group will use Listerine Total Care essential oils mouthwash, containing eucalyptol, menthol, methyl salicylate, and thymol. All participants will rinse with 10 ml twice daily for 30 seconds for 3 weeks. They should not use any form of oral hygiene during the study period. This will serve as an active control to compare the efficacy of essential oils with the pure green tea formulation and placebo.

Listerine Total Care Mouthwash

Participants will use Listerine Green Tea mouthwash, an essential oil-based product enhanced with green tea extract and fluoride. All participants will rinse with 10 ml twice daily for 30 seconds over 3 weeks. They should not use any form of oral hygiene during the study period. This will allow comparison between a commercial green tea-containing mouthwash and the pure green tea solution.

Listerine Green Tea Mouthwash

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Non-smokers
  • Systemically healthy
  • At least 24 teeth in the functional dentition, excluding third molars
  • Clinical diagnosis of periodontal health (no periodontal pockets \> 3 mm, bleeding on probing percentage \< 10%, and no attachment loss).

You may not qualify if:

  • Smokers.
  • Medically compromised patients.
  • Pregnant woman.
  • Allergies to green tea or EO.
  • Any condition that might affect the periodontal tissues.
  • Patients with any carious lesions (initial or active).
  • Patients who have overhang restorations, poorly designed crowns or bridges, and ortho retainers.
  • Use of systemic antibiotics or anti-inflammatory medications within 3 months prior to enrolment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jordan University of Science and Technology, Faculty of Dentistry

Irbid, Irbid Governorate, 22110, Jordan

RECRUITING

MeSH Terms

Conditions

Dental PlaqueGingivitisHemorrhageGingival Hemorrhage

Condition Hierarchy (Ancestors)

Dental DepositsTooth DiseasesStomatognathic DiseasesInfectionsGingival DiseasesPeriodontal DiseasesMouth DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsOral Hemorrhage

Study Officials

  • Lana Bader, DClinDent Perio

    Jordan University of Science and Technology

    STUDY DIRECTOR
  • Dana Abdullah, MClinDent Perio

    Jordan University of Science and Technology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lana Bader, DClinDent Perio

CONTACT

Dana Adel Abdullah, MClinDent Perio

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Participants, investigators, and outcome assessors will be blinded. Mouthwashs will be emptied in opaque bottles. They will be coded and unlabeled. A trained dental assisstant will be responsable about disposing the assigned mouth wash to the patient.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This is a double-blinded, parallel group, randomised, controlled, clinical trial with four arms: pure green tea mouthwash, Listerine Total Care, Listerine Green Tea, and placebo. Participants will rinse twice daily for three weeks. They will be prohibited from all forms of mechanical plaque control during the study period.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr, Assistant Professor

Study Record Dates

First Submitted

December 29, 2025

First Posted

January 23, 2026

Study Start

December 1, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

January 23, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

Individual participant data for plaque index, gingival index, discolouration index, and patient-reported outcomes will be shared. Data will be stripped of all identifiers to protect participant privacy.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
Individual Participant Data (IPD) and supporting documents (Study Protocol, Statistical Analysis Plan, Informed Consent Form, and Clinical Study Report) will be made available after publication of the study results, approximately one year after study completion.
Access Criteria
Access will be granted to qualified researchers who request the data via email to the principal investigator. Researchers must sign a data use agreement ensuring ethical use, confidentiality, and prohibition of attempts to identify participants.

Locations