Dental Caries in ChildrenNCT03571815
Cost Effectiveness of Sodium Fluoride Varnish in Prevention of Dental Caries in School Children
A study testing 5% sodium fluoride varnish and WATER ON TEETH in people with Dental Caries in Children, run by University of Peradeniya.
Trial summary
Fluoride varnish application is universally accepted as a dental caries prevention method. This study was aimed in assessment of clinical outcome and cost effectiveness in using that method in Sri Lankan school children Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Dental Caries in Children
- What is being tested?
- 5% sodium fluoride varnish and WATER ON TEETH
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 328 participants
- Where
- No sites listed yet
- Study dates
- 2 Jan 2015to 2 Jul 2017
- 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 Any age
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Children with at least one permanent tooth present.
- Age 6 to 7 years. Children under 6 years of age were enrolled in the study if at least one permanent tooth has erupted.
- Residing in Kurunegala municipal council region and tap water is consumed (fluoride levels in drinking water is normal).
- Consent from parental/ primary caregiver/ legal guardian or a family member who is the primary care provider.
Who cannot join
- Children with ulcerative gingivitis and stomatitis. (These children were referred for treatment.)
- No permanent teeth present or stainless steel crowns only
About this study
Official title: Cost Effectiveness of Sodium Fluoride Varnish Application in Prevention of Dental Caries in School Children Between Age of 6 and 7 Years
Fluoride varnish application is universally accepted as a dental caries prevention method. This study was aimed in assessment of clinical outcome and cost effectiveness in using that method in Sri Lankan school children
Read the detailed description
Background Dental caries remains a significant public health problem with multiple factors such as socioeconomic, dietary and microbiological playing a major role as risk factors in initiation and continuation of the disease. It is considered the most common cause of toothache and hospital admissions in young children. Dental caries in school children not only causes pain, but also affects school attendance, parents' work hours, children's ability to eat, play, rest and sleep. Therefore, dental caries when present significantly reduces the health related quality of life of a child.
Improving oral health has been considered as an objective in preventive dental care for children. Therefore the measures taken to prevent dental caries should include bacterial bio film control, dietary counseling, use of fluoride products such as toothpastes, mouth rinses, varnishes, gels and foams, and Casein phosphopeptide (CPP) - amorphous calcium phosphate (ACP) cream and gums and placing resin-based/glass ionomer pit and fissure sealants.) Professional fluoride varnish application has become popular among all methods as variety of studies has discussed its effect in reducing dental caries.
Fluoride varnish use in the U.S. has increased markedly since it was approved by the FDA in 1994. Fluoride varnish's effectiveness in caries prevention, ease of application, and safety give it an advantage over other types of topical fluoride treatments (such as gels and rinses) or other caries management methods. As a result, it is regarded as one of the superior topical fluoride agents for young children. Fluoride varnish also prolongs the contact time between fluoride and tooth surface to reduce caries. Its active ingredient is usually 5% sodium fluoride, or 22,600 ppm fluoride. It also has recently gained much attention in dentistry because the risk of dental fluorosis is found to be minimal.The simplicity of its application makes it very suitable and practical for use in different places and groups.
Justification Despite the availability of free health dental service in Sri Lanka, the prevalence and severity of dental caries among six and seven years old school children stand at a very high level according to the results of national oral health survey as 78% (83/84), 76.4% (94/95) and 65.5% (2002/2003) whereas the dmft is 4.4, 4.1 and 3.6.9 The simplicity of fluoride varnish application makes it very suitable and practical for use in dental clinics and outreach dental services, especially in young children and in other special needs groups.
Up to date to our knowledge, there was no other study carried out on cost effectiveness of fluoride varnish application on teeth in Sri Lankan population. Therefore, the results of the study will be beneficial in implementation and identification of advantages of fluoride varnish application on teeth in young children.
Aim The main objective of this study was to evaluate the cost effectiveness of six monthly application of sodium fluoride varnish in prevention of dental caries in deciduous teeth, permanent incisors and molars in children between six and seven years in Sri Lanka.
The specific objective is
- To find out the association between dental caries and the social status of the child (e.g. mother's education, father's education, monthly family income etc.)
Methods Study Type: Interventional This was a double-blind, randomized controlled trial. A sample of school children (6-7 years) were randomized into varnish and control groups. All the children received routine caries preventive measures of oral hygiene instructions, dietary advice and professional cleaning. Children in fluoride varnish application group received fluoride varnish professionally applied after prophylaxis every 6 months combined with counseling on maintenance of oral hygiene and diet for a period of 2 years. Clinical examinations of all children were performed at the beginning of the study and 1 year and 2 years later. All the caries at the dentinal level of both groups were stabilized with temporary restorations at the beginning. For evaluation and comparison, all the collected data was subjected to statistical analysis. Both varnish and control groups were subjected to use of fluoride tooth paste of 1000ppm. The control group was subjected to counseling on maintenance of oral hygiene and diet. During this period, the team visited each school four times at six months interval for recruitment, dental examinations, and fluoride varnish applications. Recruited children were randomly assigned to either a treatment (5% Sodium Fluoride varnish) or a control group. Trained interviewers collected data on oral health habits and sociodemographic characteristics of the children. Information on the child's diet was collected through a 4-day food frequency diary. Caries examinations were conducted using the International Caries Detection and Assessment System (ICDAS). The cost for the dental team's school visits; cost involved in the treatment of dental caries throughout the course of the study in both groups were evaluated and compared at the end of the study.
The sample size was calculated as 160 each arm to detect 5% caries change with 80% power.
Analysis The effect of intervention was measured in terms of number of caries prevented. The number of new caries in the usual care and intervention group was calculated after the completion of the study. The demographic and socioeconomic data of the intervention and usual care group were collected. The costs for intervention were estimated. The cost of treatment for caries was estimated for intervention and non-Intervention groups. The costs for the dental material, time for human resources and indirect costs were also calculated. The results were presented as cost per caries prevented.
- Conditions
- Dental Caries in Children
- Being tested
- 5% sodium fluoride varnish, WATER ON TEETH
- Keywords
- Fluoride varnish, clinical trial, dental caries
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5% sodium fluoride varnishDrug
Also called sodium fluoride varnish
application of sodium fluoride varnish on teeth
WATER ON TEETHOther
control group
| Study group | Role | What they receive |
|---|---|---|
| fluoride varnish application | Experimental | intervention; fluoride varnish application (with 5% Sodium fluoride varnish application on teeth) Receives: Drug: 5% sodium fluoride varnish |
| control group | Placebo comparator | application of water on teeth in the control group Receives: Other: WATER ON TEETH |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of number of teeth with dental caries at 6months, 1 year and 2 years from the initial presentation
change of number of new dental caries prevented using sodium fluoride varnish application at 6months, 1 year and 2years from the initial presentation for the study
Measured: 2years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2018
- Study start2 Jan 2015
- Primary completion1 Dec 2016
- Study completion2 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Caries in ChildrenStudies 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
- None (open label)
- Enrolment
- 328 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Peradeniya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. RM Jayasinghe, University of Peradeniya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03571815
- Sponsor's protocol ID
- UPeradeniya
- Status last verified
- Jun 2018
- First submitted
- 3 May 2018
- Last updated
- 29 Jun 2018
- 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 29 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost Effectiveness of Sodium Fluoride Varnish Application in Prevention of Dental Caries in School Children Between Age of 6 and 7 Years
- ClinicalTrials.gov ID
- NCT03571815
- Acronym / sponsor ID
- UPeradeniya
- Conditions
- Dental Caries in Children
- Keywords
- Fluoride varnish, clinical trial, dental caries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 328 participants (actual)
- Lead sponsor
- University of PeradeniyaUniversity, hospital or other
- Study start
- 2 Jan 2015 (actual)
- Primary completion
- 1 Dec 2016 (actual)
- Study completion
- 2 Jul 2017 (actual)
- First posted
- 28 Jun 2018 (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.
Fluoride varnish application is universally accepted as a dental caries prevention method. This study was aimed in assessment of clinical outcome and cost effectiveness in using that method in Sri Lankan school children
Detailed description
Background Dental caries remains a significant public health problem with multiple factors such as socioeconomic, dietary and microbiological playing a major role as risk factors in initiation and continuation of the disease. It is considered the most common cause of toothache and hospital admissions in young children. Dental caries in school children not only causes pain, but also affects school attendance, parents' work hours, children's ability to eat, play, rest and sleep. Therefore, dental caries when present significantly reduces the health related quality of life of a child.
Improving oral health has been considered as an objective in preventive dental care for children. Therefore the measures taken to prevent dental caries should include bacterial bio film control, dietary counseling, use of fluoride products such as toothpastes, mouth rinses, varnishes, gels and foams, and Casein phosphopeptide (CPP) - amorphous calcium phosphate (ACP) cream and gums and placing resin-based/glass ionomer pit and fissure sealants.) Professional fluoride varnish application has become popular among all methods as variety of studies has discussed its effect in reducing dental caries.
Fluoride varnish use in the U.S. has increased markedly since it was approved by the FDA in 1994. Fluoride varnish's effectiveness in caries prevention, ease of application, and safety give it an advantage over other types of topical fluoride treatments (such as gels and rinses) or other caries management methods. As a result, it is regarded as one of the superior topical fluoride agents for young children. Fluoride varnish also prolongs the contact time between fluoride and tooth surface to reduce caries. Its active ingredient is usually 5% sodium fluoride, or 22,600 ppm fluoride. It also has recently gained much attention in dentistry because the risk of dental fluorosis is found to be minimal.The simplicity of its application makes it very suitable and practical for use in different places and groups.
Justification Despite the availability of free health dental service in Sri Lanka, the prevalence and severity of dental caries among six and seven years old school children stand at a very high level according to the results of national oral health survey as 78% (83/84), 76.4% (94/95) and 65.5% (2002/2003) whereas the dmft is 4.4, 4.1 and 3.6.9 The simplicity of fluoride varnish application makes it very suitable and practical for use in dental clinics and outreach dental services, especially in young children and in other special needs groups.
Up to date to our knowledge, there was no other study carried out on cost effectiveness of fluoride varnish application on teeth in Sri Lankan population. Therefore, the results of the study will be beneficial in implementation and identification of advantages of fluoride varnish application on teeth in young children.
Aim The main objective of this study was to evaluate the cost effectiveness of six monthly application of sodium fluoride varnish in prevention of dental caries in deciduous teeth, permanent incisors and molars in children between six and seven years in Sri Lanka.
The specific objective is
- To find out the association between dental caries and the social status of the child (e.g. mother's education, father's education, monthly family income etc.)
Methods Study Type: Interventional This was a double-blind, randomized controlled trial. A sample of school children (6-7 years) were randomized into varnish and control groups. All the children received routine caries preventive measures of oral hygiene instructions, dietary advice and professional cleaning. Children in fluoride varnish application group received fluoride varnish professionally applied after prophylaxis every 6 months combined with counseling on maintenance of oral hygiene and diet for a period of 2 years. Clinical examinations of all children were performed at the beginning of the study and 1 year and 2 years later. All the caries at the dentinal level of both groups were stabilized with temporary restorations at the beginning. For evaluation and comparison, all the collected data was subjected to statistical analysis. Both varnish and control groups were subjected to use of fluoride tooth paste of 1000ppm. The control group was subjected to counseling on maintenance of oral hygiene and diet. During this period, the team visited each school four times at six months interval for recruitment, dental examinations, and fluoride varnish applications. Recruited children were randomly assigned to either a treatment (5% Sodium Fluoride varnish) or a control group. Trained interviewers collected data on oral health habits and sociodemographic characteristics of the children. Information on the child's diet was collected through a 4-day food frequency diary. Caries examinations were conducted using the International Caries Detection and Assessment System (ICDAS). The cost for the dental team's school visits; cost involved in the treatment of dental caries throughout the course of the study in both groups were evaluated and compared at the end of the study.
The sample size was calculated as 160 each arm to detect 5% caries change with 80% power.
Analysis The effect of intervention was measured in terms of number of caries prevented. The number of new caries in the usual care and intervention group was calculated after the completion of the study. The demographic and socioeconomic data of the intervention and usual care group were collected. The costs for intervention were estimated. The cost of treatment for caries was estimated for intervention and non-Intervention groups. The costs for the dental material, time for human resources and indirect costs were also calculated. The results were presented as cost per caries prevented.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fluoride varnish application | Experimental | Drug: 5% sodium fluoride varnishintervention; fluoride varnish application (with 5% Sodium fluoride varnish application on teeth) |
| control group | Placebo comparator | Other: WATER ON TEETHapplication of water on teeth in the control group |
Who may qualify
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Children with at least one permanent tooth present.
- Age 6 to 7 years. Children under 6 years of age were enrolled in the study if at least one permanent tooth has erupted.
- Residing in Kurunegala municipal council region and tap water is consumed (fluoride levels in drinking water is normal).
- Consent from parental/ primary caregiver/ legal guardian or a family member who is the primary care provider.
Key exclusion criteria (2 listed)
- Children with ulcerative gingivitis and stomatitis. (These children were referred for treatment.)
- No permanent teeth present or stainless steel crowns only
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 |
|---|---|---|
| 5% sodium fluoride varnishAlso: sodium fluoride varnishapplication of sodium fluoride varnish on teeth | Drug | fluoride varnish application |
| WATER ON TEETHcontrol group | Other | control group |
Primary outcome
change of number of teeth with dental caries at 6months, 1 year and 2 years from the initial presentation
Time frame: 2years
change of number of new dental caries prevented using sodium fluoride varnish application at 6months, 1 year and 2years from the initial presentation for the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing 5% sodium fluoride varnish and WATER ON TEETH in people with Dental Caries in Children, run by University of Peradeniya.
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 4 inclusion and 2 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: finished, as of the sponsor's last update on 29 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of number of teeth with dental caries at 6months, 1 year and 2 years from the initial presentation (time frame: 2years). 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 29 Jun 2018.