NCT04484792

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2018

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

November 27, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 27, 2020

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 24, 2020

Completed
Last Updated

July 24, 2020

Status Verified

July 1, 2020

Enrollment Period

1.3 years

First QC Date

July 21, 2020

Last Update Submit

July 22, 2020

Conditions

Plaque Induced Gingivitis

Outcome Measures

Primary Outcomes (2)

  • plaque control record

    over 27 days

  • gingival bleeding index

    over 27 days

Study Arms (3)

Group A

EXPERIMENTAL
Other: green tea mouthwash

Group B

EXPERIMENTAL
Other: green tea mouthwash

Group C

PLACEBO COMPARATOR
Other: placebo

Interventions

green tea mouthwashOTHER

green tea bags in 100 ml warm water for 5 min

Group A
placeboOTHER

Plain water

Group C

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taibah University

Al Madīnah, Saudi Arabia

Location

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 21, 2020

First Posted

July 24, 2020

Study Start

November 27, 2018

Primary Completion

March 27, 2020

Study Completion

April 20, 2020

Last Updated

July 24, 2020

Record last verified: 2020-07

Locations

SA(1)