Cost EffectivenessNCT04603573
Clinical and Cost-effectiveness of Fluoride Varnish Versus Resin Based Sealant
A study testing fluoride varnish (3M Clinpro White Varnish 5% sodium fluoride ) and Resin based fissure sealant (3M Clinpro sealant ) in people with Cost Effectiveness, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of the present study is determine the cost-effectiveness, clinical-effectiveness, acceptability and adverse effect of resin sealants versus the fluoride varnish for the prevention of dental caries on newly erupted permanent molars. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Cost Effectiveness
- What is being tested?
- fluoride varnish (3M Clinpro White Varnish 5% sodium fluoride ) and Resin based fissure sealant (3M Clinpro sealant )
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jul 2021to Sep 2022
- 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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy children with no physical or mental disorders. Children with newly fully erupted permanent molars (PMs).
Who cannot join
- Teeth will be excluded from the study if they had any of the following:
- Dental caries in dentine
- History of pain or swelling. Parents refused their children participate in the trial
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Oral and dental medicine Cairo university
Giza
Esraa Mohamed Zaghloul
About this study
Official title: Clinical and Cost-effectiveness of Fluoride Varnish Versus Resin Based Fissure Sealant in Newly Erupted Permanent Molars in Group of Egyptian Children : A Randomized Clinical Trial ( Part 1)
The aim of the present study is determine the cost-effectiveness, clinical-effectiveness, acceptability and adverse effect of resin sealants versus the fluoride varnish for the prevention of dental caries on newly erupted permanent molars.
Read the detailed description
A Cochrane systematic reviews found low quality evidence supporting Current practice guidelines that recommend the use of Resin based fissure sealant over Fluoride varnish in prevent dental caries. However, they did not address the cost-effectiveness, A more recent systematic review and meta-analysis concluded that no statistical significance difference between Resin based fissure sealant and Fluoride varnish with a high-quality evidence in prevent dental caries.
This trial will measure cost effectiveness and clinical effectiveness for resin fissure sealant and fluoride varnish.
- Conditions
- Cost Effectiveness
- Being tested
- fluoride varnish (3M Clinpro White Varnish 5% sodium fluoride ), Resin based fissure sealant (3M Clinpro sealant )
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluoride varnish (3M Clinpro White Varnish 5% sodium fluoride )Device
Also called 5% Sodium Fluoride Varnish 3M
5% Sodium Fluoride Varnish is a fluoride varnish which is applied to tooth surfaces for sealing dentinal tubules and treatment of hypersensitive teeth. The varnish is applied in a thin layer over the tooth with an applicator brush, and moisture from saliva cures the varnish for adhesion to the tooth surface.
Resin based fissure sealant (3M Clinpro sealant )Device
Also called resin fissure sealant 3M
teeth will be isolated with coton rolls and saliva ejector then etching for pits and fissure then tooth will be washed then apply resin based fissure sealant on occlusal surface.
resin fissure sealant is a more sensitive for saliva.
| Study group | Role | What they receive |
|---|---|---|
| (intervention) | Experimental | Fluoride varnish (3M Clinpro White Varnish 5% sodium fluoride). Group (1) Receives: Device: fluoride varnish (3M Clinpro White Varnish 5% sodium fluoride ) |
| comparator | Active comparator | Resin based fissure sealant (3M Clinpro Sealant, light cure, low viscosity, fluoride release).group (2) Receives: Device: Resin based fissure sealant (3M Clinpro sealant ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical-effectiveness (will be measured with DFS
Clinical-effectiveness (will be measured by DFS) Clinical effectiveness (continuous outcome will be measured with DFS D Decayed in permanent molar Filling in permanent molar S Surface
Measured: Through study completion, an average of one year
Secondary outcomes (4)
Cost-effectiveness (will be measured with Incremental cost effective ratio ICER
Cost-effectiveness (will be measured with Cost-effectiveness will be calculated based on the following measures:-
Economic measures (continuous outcome, (money) will be measured with Calculate The total cost of each of FV and FS in every visit) .
Clinical effectiveness (continuous outcome will be measured with DFS.
Measured: through study completion, an average of one year
Time of application (continuous outcome, (minutes) will be measured with stopwatch.
Time of application (continuous outcome, (minutes) will be measured with stopwatch.
Measured: Through application of interventions in treatment visit( baseline)
acceptability will be measured by questionnaire
I will ask the parent and child if this trial is acceptable or not
Measured: through study completion, an average of one year
adverse effect will be measured by questionnaire
Questionnaire for the parent (allergy, diarrhea or vomiting )
Measured: through study completion, an average of one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2020
- Study start10 Jul 2021
- Primary completionAug 2022 (estimated)
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cost EffectivenessStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Model description
- The study will be randomized, allocation-blinded, two-arm, parallel-group trial. The participants will be randomized on a 1: 1 allocation ratio to receive one of the following interventions: * Resin-based fissure sealant FS. * Fluoride varnish FV
- Masking
- None (open label)
- Enrolment
- 91 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esraa Mohamed Zaghloul, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04603573
- Sponsor's protocol ID
- 112
- Status last verified
- Jan 2021
- First submitted
- 13 Oct 2020
- Last updated
- 2 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Cost-effectiveness of Fluoride Varnish Versus Resin Based Fissure Sealant in Newly Erupted Permanent Molars in Group of Egyptian Children : A Randomized Clinical Trial ( Part 1)
- ClinicalTrials.gov ID
- NCT04603573
- Acronym / sponsor ID
- 112
- Conditions
- Cost Effectiveness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 91 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Jul 2021 (actual)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 27 Oct 2020 (actual)
- 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.
The aim of the present study is determine the cost-effectiveness, clinical-effectiveness, acceptability and adverse effect of resin sealants versus the fluoride varnish for the prevention of dental caries on newly erupted permanent molars.
Detailed description
A Cochrane systematic reviews found low quality evidence supporting Current practice guidelines that recommend the use of Resin based fissure sealant over Fluoride varnish in prevent dental caries. However, they did not address the cost-effectiveness, A more recent systematic review and meta-analysis concluded that no statistical significance difference between Resin based fissure sealant and Fluoride varnish with a high-quality evidence in prevent dental caries.
This trial will measure cost effectiveness and clinical effectiveness for resin fissure sealant and fluoride varnish.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study will be randomized, allocation-blinded, two-arm, parallel-group trial. The participants will be randomized on a 1: 1 allocation ratio to receive one of the following interventions: * Resin-based fissure sealant FS. * Fluoride varnish FV
| Arm | Type | Receives |
|---|---|---|
| (intervention) | Experimental | Device: fluoride varnish (3M Clinpro White Varnish 5% sodium fluoride )Fluoride varnish (3M Clinpro White Varnish 5% sodium fluoride). Group (1) |
| comparator | Active comparator | Device: Resin based fissure sealant (3M Clinpro sealant )Resin based fissure sealant (3M Clinpro Sealant, light cure, low viscosity, fluoride release).group (2) |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Healthy children with no physical or mental disorders. Children with newly fully erupted permanent molars (PMs).
Key exclusion criteria (3 listed)
- Teeth will be excluded from the study if they had any of the following:
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 |
|---|---|---|
| fluoride varnish (3M Clinpro White Varnish 5% sodium fluoride )Also: 5% Sodium Fluoride Varnish 3M5% Sodium Fluoride Varnish is a fluoride varnish which is applied to tooth surfaces for sealing dentinal tubules and treatment of hypersensitive teeth. The varnish is applied in a thin layer over the tooth with an applicator brush, and moisture from saliva cures the varnish for adhesion to the tooth surface. | Device | (intervention) |
| Resin based fissure sealant (3M Clinpro sealant )Also: resin fissure sealant 3Mteeth will be isolated with coton rolls and saliva ejector then etching for pits and fissure then tooth will be washed then apply resin based fissure sealant on occlusal surface. resin fissure sealant is a more sensitive for saliva. | Device | comparator |
Primary outcome
Clinical-effectiveness (will be measured with DFS
Time frame: Through study completion, an average of one year
Clinical-effectiveness (will be measured by DFS) Clinical effectiveness (continuous outcome will be measured with DFS D Decayed in permanent molar Filling in permanent molar S Surface
4 secondary outcomes
Cost-effectiveness (will be measured with Incremental cost effective ratio ICER
Time frame: through study completion, an average of one year
Time of application (continuous outcome, (minutes) will be measured with stopwatch.
Time frame: Through application of interventions in treatment visit( baseline)
acceptability will be measured by questionnaire
Time frame: through study completion, an average of one year
adverse effect will be measured by questionnaire
Time frame: through study completion, an average of one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2021.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fluoride varnish (3M Clinpro White Varnish 5% sodium fluoride ) and Resin based fissure sealant (3M Clinpro sealant ) in people with Cost Effectiveness, run by Cairo University at 1 site in Egypt.
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 1 inclusion and 3 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 2 Aug 2021. 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 Egypt. 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 Esraa Mohamed Zaghloul, B.Sc (0201146030022, Esraa.Mohamed@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical-effectiveness (will be measured with DFS (time frame: Through study completion, an average of one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Aug 2021.