Dental CariesDMFTNCT02016001
Effective Fluoride Concentration In Toothpaste For Dental Caries Prevention
A study testing toothpaste 1 with maximum fluoride concentration and toothpaste 2 with 1000 ppm of fluoride in people with Dental Caries, run by Dow University of Health Sciences at 1 site in Pakistan.
Trial summary
to identify the Effective Fluoride Concentration In Toothpaste For Dental Caries Prevention after 18 months of randomized controlled trial. Read more about this study
- Who is it for?
- Ages 12 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- toothpaste 1 with maximum fluoride concentration and toothpaste 2 with 1000 ppm of fluoride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 380 participants
- Where
- 1 sitePakistan
- Study dates
- Apr 2013to Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Regular school children of 12-15 years
- Presence of at least four molars
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Shaheen Public School
Karachi, Sindh, 0072
Dr. Aeeza Malik, BDS
About this study
Official title: Identification of Effective Fluoride Concentration In Toothpaste For Dental Caries Prevention; A Randomized Controlled Trial
to identify the Effective Fluoride Concentration In Toothpaste For Dental Caries Prevention after 18 months of randomized controlled trial.
Read the 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).
- Conditions
- Dental Caries
- Being tested
- toothpaste 1 with maximum fluoride concentration, toothpaste 2 with 1000 ppm of fluoride
- Keywords
- fluoride, dental caries, prevention
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
toothpaste 1 with maximum fluoride concentrationOther
Also called locally available tooth paste
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
toothpaste 2 with 1000 ppm of fluorideOther
Also called locally manufactured toothpaste
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 group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: toothpaste 2 with 1000 ppm of fluoride |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in DMFT (decayed, missing filled teeth) scores, over a period of 18 months.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2013 (estimated)
- Study startApr 2013
- Primary completionOct 2014 (estimated)
- Study completionOct 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 380 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DRAEEZA MALIK, Dow University of Health Sciences
- Investigators
- Dr. Ambrina Qureshi, BDS, M-Phil, Study director, Head of Community Department, Dow University of Health Sciences, Karachi, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02016001
- Sponsor's protocol ID
- draeezamalik
- Other IDs
- DUHS
- Acronym
- DMFT
- Status last verified
- Aug 2014
- First submitted
- 9 Nov 2013
- Last updated
- 13 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 20091655
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Effective Fluoride Concentration In Toothpaste For Dental Caries Prevention; A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02016001
- Acronym / sponsor ID
- DMFT / draeezamalik
- Conditions
- Dental Caries
- Keywords
- fluoride, dental caries, prevention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 380 participants (estimated)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Oct 2014 (estimated)
- Study completion
- Oct 2014 (estimated)
- First posted
- 19 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| toothpaste 1 | Experimental | Other: toothpaste 1 with maximum fluoride concentrationtooth 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 |
| toothpaste 2 | Experimental | Other: toothpaste 2 with 1000 ppm of fluoridetoothpaste 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 |
Who may qualify
- Ages
- 12 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Regular school children of 12-15 years
- Presence of at least four molars
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| toothpaste 1 with maximum fluoride concentrationAlso: locally available tooth pastetooth 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 | Other | toothpaste 1 |
| toothpaste 2 with 1000 ppm of fluorideAlso: locally manufactured toothpastetooth 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 | Other | toothpaste 2 |
Primary outcome
changes in DMFT (decayed, missing filled teeth) scores, over a period of 18 months.
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2014.
- Background: PubMed 20091655Walsh 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.
- 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;1.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Ambrina Qureshi, BDS, M-Phil study director
Head of Community Department, Dow University of Health Sciences, Karachi, Pakistan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing toothpaste 1 with maximum fluoride concentration and toothpaste 2 with 1000 ppm of fluoride in people with Dental Caries, run by Dow University of Health Sciences at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr. Aeeza Malik, BDS (0092-3126857665, draeezamalik@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in DMFT (decayed, missing filled teeth) scores, over a period of 18 months. (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02016001, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2014.