Effectiveness of Black Tea Mouthwash on Plaque Formation (Blacktea)
Primary Purpose
Gingivitis
Status
Completed
Phase
Phase 3
Locations
India
Study Type
Interventional
Intervention
Black Tea
Green Tea
0.12% Chlorhexidine Mouthwash.
Sponsored by
About this trial
This is an interventional treatment trial for Gingivitis focused on measuring Gingivitis, Black Tea, Green Tea,Chlorhexidine, Biofilm,
Eligibility Criteria
Inclusion Criteria:
- 18-40 years old. subjects with at least 20 natural teeth. diagnosed with chronic generalized plaque induced gingivitis.
Exclusion Criteria:
- subjects with systemic illness. subjects on antibiotic in the previous six months. subjects with allergy to tea. subjects on medications with effect on periodontium (Eg:anti-osteoporotic drugs).
Sites / Locations
- Sri Hasanamba Dental College and Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Black Tea
Green Tea
Chlorhexidine
Arm Description
0.5% Black Tea as Mouthwash, 5mL to be used twice daily for 30 seconds undiluted.
0.5% Green Tea as Mouthwash, 5mL to be used twice daily for 30 seconds undiluted.
0.12% Chlorhexidine Mouthwash 5mL to be used twice daily.
Outcomes
Primary Outcome Measures
Plaque Index (Silness and Loe 1964)
Plaque Index at baseline and two weeks after scaling and use of mouthwash
Secondary Outcome Measures
Gingival Index(Loe and Silness 1963)
Measure Gingival Index at baseline and two weeks after scaling and use of mouthwash
Full Information
NCT ID
NCT02545244
First Posted
September 7, 2015
Last Updated
September 7, 2015
Sponsor
Sri Hasanamba Dental College and Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02545244
Brief Title
Effectiveness of Black Tea Mouthwash on Plaque Formation
Acronym
Blacktea
Official Title
"Effectiveness of Black Tea Mouthwash on Plaque Formation:A Randomized Controlled Clinical Trial"
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sri Hasanamba Dental College and Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The study was conducted to measure the effectiveness of Black Tea in reducing the deposits on teeth. It also compares the effect between use of black tea mouthwash and green tea mouthwash to that of chlorhexidine in reducing plaque deposition on teeth in a two weeks long clinical trial among adults of 18-40 years of age.
Detailed Description
The study titled "Effectiveness of Black Tea Mouthwash on Plaque formation: A Randomized Controlled Clinical Trial" conducted at Department of Periodontics,during February 2015 till July 2015 included three interventional arms with 15 subjects each who had chronic generalized plaque-induced gingivitis. All subjects underwent scaling and randomly allocated into three groups as Black tea,Green tea and Chlorhexidine. Those in black tea, green tea and Chlorhexidine groups advised to rinse with 0.5% Black tea, 0.5% green tea and 0.12% Chlorhexidine aqueous based solutions for 30 seconds twice daily half an hour after brushing teeth respectively. Gingival Index (Loe and Silness 1963) and Plaque Index (Silness and Loe, 1964) recorded at baseline and 2 weeks after intervention in all subjects. Results were analyzed using SPSS Statistical software version 20.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingivitis
Keywords
Gingivitis, Black Tea, Green Tea,Chlorhexidine, Biofilm,
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Black Tea
Arm Type
Experimental
Arm Description
0.5% Black Tea as Mouthwash, 5mL to be used twice daily for 30 seconds undiluted.
Arm Title
Green Tea
Arm Type
Active Comparator
Arm Description
0.5% Green Tea as Mouthwash, 5mL to be used twice daily for 30 seconds undiluted.
Arm Title
Chlorhexidine
Arm Type
Active Comparator
Arm Description
0.12% Chlorhexidine Mouthwash 5mL to be used twice daily.
Intervention Type
Dietary Supplement
Intervention Name(s)
Black Tea
Intervention Description
0.5% Black Tea 5mL used as Mouthwash twice daily for two weeks after scaling of teeth.
Intervention Type
Dietary Supplement
Intervention Name(s)
Green Tea
Intervention Description
0.5% Green Tea 5mL used as Mouthwash twice daily for two weeks after scaling of teeth.
Intervention Type
Drug
Intervention Name(s)
0.12% Chlorhexidine Mouthwash.
Intervention Description
5mL of 0.12% Chlorhexidine used as mouthwash twice daily for two weeks after scaling of teeth.
Primary Outcome Measure Information:
Title
Plaque Index (Silness and Loe 1964)
Description
Plaque Index at baseline and two weeks after scaling and use of mouthwash
Time Frame
two weeks
Secondary Outcome Measure Information:
Title
Gingival Index(Loe and Silness 1963)
Description
Measure Gingival Index at baseline and two weeks after scaling and use of mouthwash
Time Frame
two weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
18-40 years old. subjects with at least 20 natural teeth. diagnosed with chronic generalized plaque induced gingivitis.
Exclusion Criteria:
subjects with systemic illness. subjects on antibiotic in the previous six months. subjects with allergy to tea. subjects on medications with effect on periodontium (Eg:anti-osteoporotic drugs).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ShivaMurthy Ravindra, MDS
Organizational Affiliation
Sri Hasanamba Dental College and Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sri Hasanamba Dental College and Hospital
City
Hassan
State/Province
Karnataka
ZIP/Postal Code
573202
Country
India
12. IPD Sharing Statement
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Effectiveness of Black Tea Mouthwash on Plaque Formation
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