NCT02545244

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2015

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 9, 2015

Completed
Last Updated

September 9, 2015

Status Verified

September 1, 2015

Enrollment Period

4 months

First QC Date

September 7, 2015

Last Update Submit

September 7, 2015

Conditions

Keywords

Gingivitis, Black Tea, Green Tea,Chlorhexidine, Biofilm,

Outcome Measures

Primary Outcomes (1)

  • Plaque Index (Silness and Loe 1964)

    Plaque Index at baseline and two weeks after scaling and use of mouthwash

    two weeks

Secondary Outcomes (1)

  • Gingival Index(Loe and Silness 1963)

    two weeks

Study Arms (3)

Black Tea

EXPERIMENTAL

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

Dietary Supplement: Black Tea

Green Tea

ACTIVE COMPARATOR

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

Dietary Supplement: Green Tea

Chlorhexidine

ACTIVE COMPARATOR

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

Drug: 0.12% Chlorhexidine Mouthwash.

Interventions

Black TeaDIETARY_SUPPLEMENT

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

Black Tea
Green TeaDIETARY_SUPPLEMENT

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

Green Tea

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

Chlorhexidine

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years old. subjects with at least 20 natural teeth. diagnosed with chronic generalized plaque induced gingivitis.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sri Hasanamba Dental College and Hospital

Hassan, Karnataka, 573202, India

Location

MeSH Terms

Conditions

Gingivitis

Interventions

Tea

Condition Hierarchy (Ancestors)

InfectionsGingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Plant PreparationsBiological ProductsComplex MixturesBeveragesDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • ShivaMurthy Ravindra, MDS

    Sri Hasanamba Dental College and Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MDS Student in Periodontics

Study Record Dates

First Submitted

September 7, 2015

First Posted

September 9, 2015

Study Start

February 1, 2015

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

September 9, 2015

Record last verified: 2015-09

Locations