Green Tea Mouthwash on Generalized Plaque- Induced Gingivitis

NCT ID: NCT04484792

Last Updated: 2020-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-27

Study Completion Date

2020-04-20

Brief Summary

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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.

Detailed Description

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Conditions

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Plaque Induced Gingivitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Group A

Group Type EXPERIMENTAL

green tea mouthwash

Intervention Type OTHER

green tea bags in 100 ml warm water for 5 min

Group B

Group Type EXPERIMENTAL

green tea mouthwash

Intervention Type OTHER

, in Group B its prepared by soaking tea bags in 100 ml hot water followed by ice addition.

Group C

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

Plain water

Interventions

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green tea mouthwash

green tea bags in 100 ml warm water for 5 min

Intervention Type OTHER

green tea mouthwash

, in Group B its prepared by soaking tea bags in 100 ml hot water followed by ice addition.

Intervention Type OTHER

placebo

Plain water

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Taibah University

OTHER

Sponsor Role lead

Responsible Party

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Alhanouf M. AlRehaili

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Taibah University

Al Madīnah, , Saudi Arabia

Site Status

Countries

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Saudi Arabia

Other Identifiers

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TUCDREC/20181112/AlRehaili

Identifier Type: -

Identifier Source: org_study_id

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