Effectiveness of Black Tea Mouthwash on Plaque Formation

NCT ID: NCT02545244

Last Updated: 2015-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2015-06-30

Brief Summary

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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

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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.

Conditions

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Gingivitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Black Tea

0.5% Black Tea as Mouthwash, 5mL to be used twice daily for 30 seconds undiluted.

Group Type EXPERIMENTAL

Black Tea

Intervention Type DIETARY_SUPPLEMENT

0.5% Black Tea 5mL used as Mouthwash twice daily for two weeks after scaling of teeth.

Green Tea

0.5% Green Tea as Mouthwash, 5mL to be used twice daily for 30 seconds undiluted.

Group Type ACTIVE_COMPARATOR

Green Tea

Intervention Type DIETARY_SUPPLEMENT

0.5% Green Tea 5mL used as Mouthwash twice daily for two weeks after scaling of teeth.

Chlorhexidine

0.12% Chlorhexidine Mouthwash 5mL to be used twice daily.

Group Type ACTIVE_COMPARATOR

0.12% Chlorhexidine Mouthwash.

Intervention Type DRUG

5mL of 0.12% Chlorhexidine used as mouthwash twice daily for two weeks after scaling of teeth.

Interventions

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Black Tea

0.5% Black Tea 5mL used as Mouthwash twice daily for two weeks after scaling of teeth.

Intervention Type DIETARY_SUPPLEMENT

Green Tea

0.5% Green Tea 5mL used as Mouthwash twice daily for two weeks after scaling of teeth.

Intervention Type DIETARY_SUPPLEMENT

0.12% Chlorhexidine Mouthwash.

5mL of 0.12% Chlorhexidine used as mouthwash twice daily for two weeks after scaling of teeth.

Intervention Type DRUG

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sri Hasanamba Dental College and Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dr. Smitha K.B

MDS Student in Periodontics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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ShivaMurthy Ravindra, MDS

Role: PRINCIPAL_INVESTIGATOR

Sri Hasanamba Dental College and Hospital

Locations

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Sri Hasanamba Dental College and Hospital

Hassan, Karnataka, India

Site Status

Countries

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India

Other Identifiers

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SHDCH/2015-16/1107

Identifier Type: -

Identifier Source: org_study_id

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