Effectiveness of Black Tea Mouthwash on Plaque Formation

Gingivitis Clinical Trial

— Blacktea  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02545244
• Other study ID #: SHDCH/2015-16/1107
• Status: Completed
• Phase: Phase 3
• First received: September 7, 2015
• Last updated: September 7, 2015
• Start date: February 2015
• Est. completion date: June 2015

Study information

• Verified date: September 2015
• Source: Sri Hasanamba Dental College and Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gingivitis

Intervention

Dietary Supplement:
• Black Tea
0.5% Black Tea 5mL used as Mouthwash twice daily for two weeks after scaling of teeth.
• Green Tea
0.5% Green Tea 5mL used as Mouthwash twice daily for two weeks after scaling of teeth.

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

Locations

Country	Name	City	State
India	Sri Hasanamba Dental College and Hospital	Hassan	Karnataka

Sponsors (1)

Lead Sponsor	Collaborator
Sri Hasanamba Dental College and Hospital

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plaque Index (Silness and Loe 1964)	Plaque Index at baseline and two weeks after scaling and use of mouthwash	two weeks	No
Secondary	Gingival Index(Loe and Silness 1963)	Measure Gingival Index at baseline and two weeks after scaling and use of mouthwash	two weeks	No