Back to resultsGreen Tea Mouthwash on Generalized Plaque- Induced Gingivitis
Primary Purpose
Plaque Induced Gingivitis
Status
Completed
Phase
Phase 3
Locations
Saudi Arabia
Study Type
Interventional
Intervention
green tea mouthwash
green tea mouthwash
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Plaque Induced Gingivitis
Eligibility Criteria
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)
Sites / Locations
- Taibah University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Group A
Group B
Group C
Arm Description
Outcomes
Primary Outcome Measures
plaque control record
gingival bleeding index
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04484792
Brief Title
Green Tea Mouthwash on Generalized Plaque- Induced Gingivitis
Official Title
Green Tea Mouthwash on Generalized Plaque- Induced Gingivitis: A Randomized Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
November 27, 2018 (Actual)
Primary Completion Date
March 27, 2020 (Actual)
Study Completion Date
April 20, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taibah University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plaque Induced Gingivitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Title
Group B
Arm Type
Experimental
Arm Title
Group C
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
green tea mouthwash
Intervention Description
green tea bags in 100 ml warm water for 5 min
Intervention Type
Other
Intervention Name(s)
green tea mouthwash
Intervention Description
, in Group B its prepared by soaking tea bags in 100 ml hot water followed by ice addition.
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
Plain water
Primary Outcome Measure Information:
Title
plaque control record
Time Frame
over 27 days
Title
gingival bleeding index
Time Frame
over 27 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Facility Information:
Facility Name
Taibah University
City
Al Madīnah
Country
Saudi Arabia
12. IPD Sharing Statement
Learn more about this trial
Green Tea Mouthwash on Generalized Plaque- Induced Gingivitis
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