Effective Fluoride Concentration In Toothpaste For Dental Caries Prevention

Identification of Effective Fluoride Concentration In Toothpaste For Dental Caries Prevention; A Randomized Controlled Trial

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02016001

Acronym

DMFT

Enrollment

380

Registered

2013-12-19

Start date

2013-04-30

Completion date

2014-10-31

Last updated

2014-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Caries

Keywords

fluoride, dental caries, prevention

Brief summary

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

Detailed description

In developed countries, well-controlled clinical trials have investigated the effective fluoride level in toothpaste and provided irresistible data in relation to the caries controlling efficacy of tooth pastes. But there has been no such data reported in our part of the world. This indicates the need to determine the effective concentration of fluoride in locally manufactured tooth pastes for accomplishment of the goal of prevention against dental caries. This will be a Parallel Group, Double-Blind, Randomized Controlled Trial, over a period of 18 months. The study will be conducted in a randomly selected school of Karachi city. Participants will be the cohort of regular school children aged 12-14 years. Sample size for the present study attained was 330 (165 in both groups), expected attrition rate will be kept as 15%, so the total sample size is 330 + 50 = 380 (190 in each group).

Interventions

OTHERtoothpaste 1 with maximum fluoride concentration

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

OTHERtoothpaste 2 with 1000 ppm of fluoride

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

12 Years to 15 Years

Healthy volunteers

Yes

Inclusion criteria

1. Regular school children of 12-15 years 2. Presence of at least four molars

Exclusion criteria

1. Non- consenting cases 2. Medically/physically compromised children 3. Children under any kind of parallel fluoride regime (systemic or topical) 4. Children consuming diet that is different from routine dietary practices 5. Children using toothpaste with greater than 1100 ppm and less than 500 ppm of fluoride 6. Children found with rampant caries 7. Children found with all filled molars 8. Children with any oral infection abscess, periodontitis etc 9. Dentition with malocclusion 10. Children undergoing orthodontic/prosthodontic treatment 11. Children with Temporo mandibular joint disorder 12. Children who missed the baseline examinations 13. Loss to any follow-up cases

Design outcomes

Primary

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

Countries

Pakistan

Contacts

Primary ContactDr. Aeeza Malik, BDS

draeezamalik@hotmail.com0092-3126857665

Backup ContactDr. Malik Saleem, BDS, MSc

malik_ss79@hotmail.com0092-3334710057

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026