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Comparative Effect of Chewing Sticks and Toothbrushing on Plaque Removal and Gingival Health

Primary Purpose

Plaque Induced Gingivitis

Status

Completed

Phase

Not Applicable

Locations

Saudi Arabia

Study Type

Interventional

Intervention

Salvadora persica

Toothbrush

About this trial

This is an interventional treatment trial for Plaque Induced Gingivitis focused on measuring gingivitis, dental plaque, oral hygiene, toothbrush, chewing sticks

Eligibility Criteria

20 Years - 30 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

Healthy individuals
presence of at least 14 teeth

Exclusion Criteria:

Subjects on medications (antiinflammatory or antibiotics)

Sites / Locations

Faculty of Dentistry Taibah University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Miswak, dental plaque and gingivitis

Toothbrush, dental plaque and gingivitis

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01336179

First Posted

April 6, 2011

Last Updated

May 31, 2011

Sponsor

Taibah University

1. Study Identification

Unique Protocol Identification Number

NCT01336179

Brief Title

Comparative Effect of Chewing Sticks and Toothbrushing on Plaque Removal and Gingival Health

Official Title

The Efficacy of the Miswak Chewing Sticks (Salvadora Persica)on Plaque Removal and Gingival Health: Randomised Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

April 2011

Overall Recruitment Status

Completed

Study Start Date

March 2011 (undefined)

Primary Completion Date

April 2011 (Actual)

Study Completion Date

May 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Taibah University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Plaque Induced Gingivitis

Keywords

gingivitis, dental plaque, oral hygiene, toothbrush, chewing sticks

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Miswak, dental plaque and gingivitis

Arm Type

Experimental

Arm Title

Toothbrush, dental plaque and gingivitis

Arm Type

Active Comparator

Intervention Type

Procedure

Intervention Name(s)

Salvadora persica

Intervention Description

twice daily use, two minutes interval

Intervention Type

Procedure

Intervention Name(s)

Toothbrush

Intervention Description

Twice daily use two minutes interval

Primary Outcome Measure Information:

Title

Miswak is useful for removing plaque and preventing gingivitis

Description

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.

Time Frame

6 weeks

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

30 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Healthy individuals presence of at least 14 teeth Exclusion Criteria: Subjects on medications (antiinflammatory or antibiotics)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tareq AS Abu Saleh, MSc, MRD

Organizational Affiliation

Assistant professor in Periodontics, Taibah University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Faculty of Dentistry Taibah University

City

Almadinah

ZIP/Postal Code

Country

Saudi Arabia

12. IPD Sharing Statement

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Comparative Effect of Chewing Sticks and Toothbrushing on Plaque Removal and Gingival Health

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