Green Tea Mouthwash on Generalized Plaque- Induced Gingivitis

Green Tea Mouthwash on Generalized Plaque- Induced Gingivitis: A Randomized Controlled Clinical Trial

This investigation will study the effect of green tea mouthwash as an adjunctive therapy to mechanical treatment on gingival health, and whether it has any side effects. This study also aims at increasing the awareness among health professionals and the community regarding the benefits of natural herbal products such as green tea on oral health, opposed to common chemical products. This may provide an efficient alternative for people who are sensitive to certain chemical products or who have limited sources of income and cannot afford expensive treatment of dental problems.

Study Overview

• Status: Completed
• Conditions: Plaque Induced Gingivitis
• Intervention / Treatment: Other: green tea mouthwash; Other: green tea mouthwash; Other: placebo

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Phase 3

Contacts and Locations

Study Locations

• Saudi Arabia
  • Al Madīnah, Saudi Arabia
    • Taibah University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Patients attending the clinics at the Taibah University Dental College and Hospital (TUDCH)
• Age from 18 - 35 years
• Generalized plaque-induced gingivitis (GBI > 85%)

Exclusion Criteria:

• Patients with any systemic diseases
• Patients under regular medication (e.g. Contraceptives, Hormone- Replacement Therapy)
• Pregnant or breast-feeding patients
• Smokers
• Periodontitis patients
• Patients who received any form of periodontal therapy within the last 6 months
• Patients who were under antibiotic therapy the past month
• Patients using regular mouthwash or other chemical plaque control agents (e.g. Miswak) except for regular toothpaste (Note: toothpastes with specific anti-inflammatory properties are excluded)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: FACTORIAL
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Group A	Other: green tea mouthwash; green tea bags in 100 ml warm water for 5 min; Other: green tea mouthwash; , in Group B its prepared by soaking tea bags in 100 ml hot water followed by ice addition.
EXPERIMENTAL: Group B	Other: green tea mouthwash; green tea bags in 100 ml warm water for 5 min; Other: green tea mouthwash; , in Group B its prepared by soaking tea bags in 100 ml hot water followed by ice addition.
PLACEBO_COMPARATOR: Group C	Other: placebo; Plain water

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
plaque control record	over 27 days
gingival bleeding index	over 27 days

Collaborators and Investigators

• Sponsor: Taibah University

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 27, 2018
• Primary Completion (ACTUAL): March 27, 2020
• Study Completion (ACTUAL): April 20, 2020

Study Registration Dates

• First Submitted: July 21, 2020
• First Submitted That Met QC Criteria: July 22, 2020
• First Posted (ACTUAL): July 24, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 24, 2020
• Last Update Submitted That Met QC Criteria: July 22, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Gingivitis
• Other Study ID Numbers: TUCDREC/20181112/AlRehaili

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No