NCT01336179

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2011

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

April 6, 2011

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 15, 2011

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

June 1, 2011

Status Verified

April 1, 2011

Enrollment Period

1 month

First QC Date

April 6, 2011

Last Update Submit

May 31, 2011

Conditions

Keywords

gingivitisdental plaqueoral hygienetoothbrushchewing sticks

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Miswak, dental plaque and gingivitis

EXPERIMENTAL
Procedure: Salvadora persica

Toothbrush, dental plaque and gingivitis

ACTIVE COMPARATOR
Procedure: Toothbrush

Interventions

twice daily use, two minutes interval

Miswak, dental plaque and gingivitis
ToothbrushPROCEDURE

Twice daily use two minutes interval

Toothbrush, dental plaque and gingivitis

Eligibility Criteria

Age20 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy individuals
  • presence of at least 14 teeth

You may not qualify if:

  • Subjects on medications (antiinflammatory or antibiotics)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry Taibah University

Al Madīnah, Almadinah, 04, Saudi Arabia

Location

MeSH Terms

Conditions

GingivitisDental Plaque

Condition Hierarchy (Ancestors)

InfectionsGingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesDental DepositsTooth Diseases

Study Officials

  • Tareq AS Abu Saleh, MSc, MRD

    Assistant professor in Periodontics, Taibah University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 6, 2011

First Posted

April 15, 2011

Study Start

March 1, 2011

Primary Completion

April 1, 2011

Study Completion

May 1, 2011

Last Updated

June 1, 2011

Record last verified: 2011-04

Locations