Comparative Effect of Chewing Sticks and Toothbrushing on... | NCT01336179

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

NCT01336179

Sponsor

Taibah University

Status

Completed

Last Update Posted

Jun 1, 2011Estimated

Enrollment

18Estimated

Phase

Not Applicable

Conditions

Plaque Induced Gingivitis

Interventions

Salvadora persica
Toothbrush

Countries

Saudi Arabia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2011

Primary Completion Date

Apr 2011Actual

Completion Date

May 2011Actual

First Submitted Date

Apr 6, 2011

First Submission Date that Met QC Criteria

Apr 13, 2011

First Posted Date

Apr 15, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 31, 2011

Last Update Posted Date

Jun 1, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

18Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Miswak, dental plaque and gingivitis	Experimental		Procedure: Salvadora persica
Toothbrush, dental plaque and gingivitis	Active Comparator		Procedure: Toothbrush

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Salvadora persica	Procedure	twice daily use, two minutes interval	Miswak, dental plaque and gingivitis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy individuals
presence of at least 14 teeth

Exclusion Criteria:

Subjects on medications (antiinflammatory or antibiotics)

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

30 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tareq AS Abu Saleh, MSc, MRD	Assistant professor in Periodontics, Taibah University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Dentistry Taibah University		Al Madīnah	Almadinah	04	Saudi Arabia

Condition Browse Module

MeSH Terms

ID	Term
D005891	Gingivitis
D003773	Dental Plaque

Ancestor Terms

ID	Term
D007239	Infections
D005882	Gingival Diseases
D010510	Periodontal Diseases
D009059	Mouth Diseases

Browse Leaves

Not provided

Browse Branches

Not provided