NCT02016001

Brief Summary

to identify the Effective Fluoride Concentration In Toothpaste For Dental Caries Prevention after 18 months of randomized controlled trial.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
380

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2013

Geographic Reach
1 country

1 active site

Status
unknown

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

April 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 9, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 19, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

August 13, 2014

Status Verified

August 1, 2014

Enrollment Period

1.5 years

First QC Date

November 9, 2013

Last Update Submit

August 11, 2014

Conditions

Dental Caries

Keywords

fluoridedental cariesprevention

Outcome Measures

Primary Outcomes (1)

  • changes in DMFT (decayed, missing filled teeth) scores, over a period of 18 months.

    18 months

Study Arms (2)

toothpaste 1

EXPERIMENTAL

tooth paste 1 will be the tested intervention with maximum fluoride concentration (1500ppm), which will be provided to the case group. They will brush the teeth twice daily for 2 minutes

Other: toothpaste 1 with maximum fluoride concentration

toothpaste 2

EXPERIMENTAL

toothpaste 2 will be the intervention with 1000 ppm of fluoride, which will be used by control group. They will brush the teeth twice daily for 2 minutes

Other: toothpaste 2 with 1000 ppm of fluoride

Interventions

toothpaste 1 with maximum fluoride concentrationOTHER

tooth paste 1 will be the tested intervention with maximum fluoride concentration (1500 ppm), which will be provided to the case group. They will brush the teeth twice daily for 2 minutes

Also known as: locally available tooth paste
toothpaste 1
toothpaste 2 with 1000 ppm of fluorideOTHER

tooth paste 2 will be the intervention with 1000ppm of fluoride, will be used by the control group. They will brush the teeth twice daily for 2 minutes

Also known as: locally manufactured toothpaste
toothpaste 2

Eligibility Criteria

Age12 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Regular school children of 12-15 years
  • Presence of at least four molars

You may not qualify if:

  • Non- consenting cases
  • Medically/physically compromised children
  • Children under any kind of parallel fluoride regime (systemic or topical)
  • Children consuming diet that is different from routine dietary practices
  • Children using toothpaste with greater than 1100 ppm and less than 500 ppm of fluoride
  • Children found with rampant caries
  • Children found with all filled molars
  • Children with any oral infection abscess, periodontitis etc
  • Dentition with malocclusion
  • Children undergoing orthodontic/prosthodontic treatment
  • Children with Temporo mandibular joint disorder
  • Children who missed the baseline examinations
  • Loss to any follow-up cases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shaheen Public School

Karachi, Sindh, 0072, Pakistan

RECRUITING

Related Publications (1)

  • Walsh T, Worthington HV, Glenny AM, Appelbe P, Marinho VC, Shi X. Fluoride toothpastes of different concentrations for preventing dental caries in children and adolescents. Cochrane Database Syst Rev. 2010 Jan 20;(1):CD007868. doi: 10.1002/14651858.CD007868.pub2.

    PMID: 20091655BACKGROUND

Related Links

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Officials

  • Dr. Ambrina Qureshi, BDS, M-Phil

    Head of Community Department, Dow University of Health Sciences, Karachi, Pakistan

    STUDY DIRECTOR

Central Study Contacts

Dr. Aeeza Malik, BDS

CONTACT

0092-3126857665draeezamalik@hotmail.com

Dr. Malik Saleem, BDS, MSc

CONTACT

0092-3334710057malik_ss79@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
dr.

Study Record Dates

First Submitted

November 9, 2013

First Posted

December 19, 2013

Study Start

April 1, 2013

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

August 13, 2014

Record last verified: 2014-08

Locations

PA(1)