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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01336179
Other study ID # UTFD201127021
Secondary ID
Status Completed
Phase N/A
First received April 6, 2011
Last updated May 31, 2011
Start date March 2011
Est. completion date May 2011

Study information

Verified date April 2011
Source Taibah University
Contact n/a
Is FDA regulated No
Health authority Saudi Arabia: Ministry for Higher Education
Study type Interventional

Clinical Trial Summary

The purpose of the proposed study is to compare the effect of chewing sticks (Miswak) and the toothbrushes on plaque removal and gingival health.


Description:

Dental plaque removal is essential in maintaining oral health. Methods for oral hygiene vary from country to country and from culture to culture. The use of a wood stick (miswak or chewing stick) for brushing the teeth is considered an important tool for oral hygiene care in many Afro-Asian communities. The aim of the study is to compare the effect of the chewing stick (miswak), and toothbrushing on plaque removal and gingival health. The participants comprise 18 healthy Saudi Arabian male volunteers aged 21 to 30 years, at Taibah University in Saudi Arabia. The study was designed as a single, blind, randomized split-mouth study. Professional tooth cleaning was conducted, and after six weeks use of either the miswak or toothbrush on each quadrant, modified plaque and gingival indices, were recorded.


Recruitment information / eligibility

Status Completed
Enrollment 18
Est. completion date May 2011
Est. primary completion date April 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 20 Years to 30 Years
Eligibility Inclusion Criteria:

- Healthy individuals

- presence of at least 14 teeth

Exclusion Criteria:

- Subjects on medications (antiinflammatory or antibiotics)

Study Design

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


Related Conditions & MeSH terms


Intervention

Procedure:
Salvadora persica
twice daily use, two minutes interval
Toothbrush
Twice daily use two minutes interval

Locations

Country Name City State
Saudi Arabia Faculty of Dentistry Taibah University Almadinah

Sponsors (1)

Lead Sponsor Collaborator
Taibah University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Miswak is useful for removing plaque and preventing gingivitis Miswak will be compared to toothbrush as a mechanical plaque control device, by calculating plaque index and gingival index scores for participants after 6 weeks of use. 6 weeks Yes
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