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Green Tea Mouthwash on Generalized Plaque- Induced Gingivitis

Sponsor
Taibah University (Other)
Overall Status
Completed
CT.gov ID
NCT04484792
Collaborator
(none)
45
Enrollment
1
Location
3
Arms
16.8
Actual Duration (Months)
2.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: green tea mouthwash
  • Other: green tea mouthwash
  • Other: placebo
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
45 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
Green Tea Mouthwash on Generalized Plaque- Induced Gingivitis: A Randomized Controlled Clinical Trial
Actual Study Start Date :
Nov 27, 2018
Actual Primary Completion Date :
Mar 27, 2020
Actual Study Completion Date :
Apr 20, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group A

Other: green tea mouthwash
green tea bags in 100 ml warm water for 5 min
Experimental: Group B

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

Outcome Measures

Primary Outcome Measures

  1. plaque control record [over 27 days]

  2. gingival bleeding index [over 27 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 35 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Taibah University Al Madīnah Saudi Arabia

Sponsors and Collaborators

  • Taibah University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Alhanouf M. AlRehaili, Principal Investigator, Taibah University
ClinicalTrials.gov Identifier:
NCT04484792
Other Study ID Numbers:
  • TUCDREC/20181112/AlRehaili
First Posted:
Jul 24, 2020
Last Update Posted:
Jul 24, 2020
Last Verified:
Jul 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Gingivitis

Study Results

No Results Posted as of Jul 24, 2020