Green Tea Mouthwash on Generalized Plaque- Induced Gingivitis

Plaque Induced Gingivitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04484792
• Other study ID #: TUCDREC/20181112/AlRehaili
• Status: Completed
• Phase: Phase 3
• Start date: November 27, 2018
• Est. completion date: April 20, 2020

Study information

• Verified date: July 2020
• Source: Taibah University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: April 20, 2020
• Est. primary completion date: March 27, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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)

Related Conditions & MeSH terms

• Gingivitis
• Plaque Induced Gingivitis

Intervention

Other:
• green tea mouthwash
green tea bags in 100 ml warm water for 5 min
• green tea mouthwash
, in Group B its prepared by soaking tea bags in 100 ml hot water followed by ice addition.
• placebo
Plain water

Locations

Country	Name	City	State
Saudi Arabia	Taibah University	Al Madinah

Sponsors (1)

Lead Sponsor	Collaborator
Taibah University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	plaque control record		over 27 days
Primary	gingival bleeding index		over 27 days