Effectiveness of Black Tea Mouthwash on Plaque Formation (Blacktea)

September 7, 2015 updated by: Dr. Smitha K.B, Sri Hasanamba Dental College and Hospital

"Effectiveness of Black Tea Mouthwash on Plaque Formation:A Randomized Controlled Clinical Trial"

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Karnataka
      • Hassan, Karnataka, India, 573202
        • Sri Hasanamba Dental College and Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Black Tea
0.5% Black Tea as Mouthwash, 5mL to be used twice daily for 30 seconds undiluted.
Dietary supplement: Black Tea
0.5% Black Tea 5mL used as Mouthwash twice daily for two weeks after scaling of teeth.
Active Comparator: Green Tea
0.5% Green Tea as Mouthwash, 5mL to be used twice daily for 30 seconds undiluted.
Dietary supplement: Green Tea
0.5% Green Tea 5mL used as Mouthwash twice daily for two weeks after scaling of teeth.
Active Comparator: Chlorhexidine
0.12% Chlorhexidine Mouthwash 5mL to be used twice daily.
Drug: 0.12% Chlorhexidine Mouthwash.
5mL of 0.12% Chlorhexidine used as mouthwash twice daily for two weeks after scaling of teeth.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plaque Index (Silness and Loe 1964)
Time Frame: two weeks
Plaque Index at baseline and two weeks after scaling and use of mouthwash
two weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gingival Index(Loe and Silness 1963)
Time Frame: two weeks
Measure Gingival Index at baseline and two weeks after scaling and use of mouthwash
two weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sri Hasanamba Dental College and Hospital

Investigators

  • Principal Investigator: ShivaMurthy Ravindra, MDS, Sri Hasanamba Dental College and Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

September 7, 2015

First Submitted That Met QC Criteria

September 7, 2015

First Posted (Estimate)

September 9, 2015

Study Record Updates

Last Update Posted (Estimate)

September 9, 2015

Last Update Submitted That Met QC Criteria

September 7, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHDCH/2015-16/1107

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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