ChildNCT03360266
Evaluation of Remineralizing Efficacy of Combination Varnishes on White Spot Lesions in ECC Children
A study testing Sodium Fluoride with CPP-ACP varnish, sodium fluoride with ACP varnish and 5% Sodium Fluoride Varnish in people with Child and Early Childhood Caries, run by Indira Gandhi Institute of Dental Science.
Trial summary
The remineralizing efficacy of 3 fluoride varnishes were assessed in children with white spot lesion under 6 years of age ( children with early childhood caries) Read more about this study
- Who is it for?
- Ages 3 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Child, Early Childhood Caries
- What is being tested?
- Sodium Fluoride with CPP-ACP varnish, sodium fluoride with ACP varnish and 5% Sodium Fluoride Varnish
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 21 Mar 2016to 17 Mar 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 3 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Preschool children with ECC.
- Children with active white spot lesions on labial surface of 1 or more primary maxillary anterior teeth.
- Children whose parents signed the informed consent form/willing to participate in the study.
- Apart from fluoride varnish and fluoridated tooth paste, subjects exposed to no other form of fluoride were included.
Who cannot join
- Preschool children with cavitated lesions on primary maxillary anterior teeth.
- Developmental enamel alterations (hypoplasia, fluorosis).
- Children with systemic diseases.
- Children with allergy to milk products.
About this study
Official title: Comparative Evaluation of Remineralizing Efficacy of Fluoride Varnish and Its Combination Varnishes on White Spot Lesions in Children With ECC: A Randomized Clinical Trial
The remineralizing efficacy of 3 fluoride varnishes were assessed in children with white spot lesion under 6 years of age ( children with early childhood caries)
Read the detailed description
Early childhood caries (ECC) is the presence of 1 or more decayed (Non - Cavitated or Cavitated lesions), missing (due to caries) or filled tooth surface in any primary tooth in a child of 71 months of age or younger. In children younger than 3 years of age, any sign of smooth-surface caries is indicative of severe early childhood caries (S-ECC). It is a virulent form of caries, which develops on smooth surfaces and progresses rapidly. In children aged 12 to 30 months it initially affects the maxillary primary incisors and first primary molars, reflecting the pattern of eruption.
In ECC, the first clinical observation of demineralization in enamel is the white spot lesion, which is characterized by enamel demineralization of the subsurface, with increasing porosity due to the removal of minerals into the outer surface. At this stage, the caries lesion is usually reversible.
In young children, remineralization can be achieved by Non- invasive methods that are very effective. Fluoride prevents the caries process, leading to the formation of less soluble fluorapatite crystals. Among them, Topical fluorides are the most respected regimen. On application of topical fluorides to the teeth, calcium fluoride-like globules are formed on the tooth surface. These globules are effective mineral reservoirs that help prevent demineralization and promote remineralization by releasing calcium, phosphate and fluoride following acid attacks.
American Academy of Pediatric Dentistry (AAPD) recommends fluoride varnish in children. Randomized control trials have found it to be efficacious in primary teeth. Fluoride varnish can reverse or arrest caries lesions as well as prevent demineralization process of an incipient caries/white spot lesion, when combined with other preventive measures such as oral hygiene instructions \& diet counseling.Children at increased caries risk should receive a professional fluoride treatment at least every six months. There is evidence from randomized controlled trials and meta-analyses that professionally applied topical fluoride treatments as five percent sodium fluoride varnish or 1.23 percent fluoride gel preparations are efficacious in reducing caries in children at caries risk.
Fluoride varnish works by increasing the concentration of fluoride in the outer surface of teeth, thereby enhancing fluoride uptake during early stages of demineralization. The varnish hardens on the tooth as soon as it contacts saliva, allowing the high concentration of fluoride to be in contact with tooth enamel for an extended period of time This is a much longer exposure compared to other high-dose topical fluorides such as gels or foams, with less risk of fluorosis even in children younger than 6 years.
It has been observed from the literature review that only invitro studies and few clinical studies have been done in treating WSL in orthodontic patients using these combination varnishes. To our Knowledge, no clinical studies has assessed its efficacy and compared the effectiveness of these combination varnishes in remineralising white spot lesions of ECC in young children. Thus, this study was planned to compare the remineralizing efficiency of fluoride varnish with a combination of fluoride and calcium phosphate varnishes on white spot lesions in smooth surfaces of primary anterior teeth of children with ECC.
- Conditions
- Child, Early Childhood Caries
- Being tested
- Sodium Fluoride with CPP-ACP varnish, sodium fluoride with ACP varnish, 5% Sodium Fluoride Varnish
- Keywords
- remineralization, fluoride varnish
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium Fluoride with CPP-ACP varnishCombination product
Also called MI varnish
for children with ECC, this varnish effectively remineralizes the white spot lesion
sodium fluoride with ACP varnishCombination product
Also called Enamel Pro
for children with ECC, this varnish effectively remineralizes the white spot lesion
5% Sodium Fluoride VarnishDrug
Also called Profluorid
ffor children with ECC, this varnish effectively remineralizes the white spot lesion
| Study group | Role | What they receive |
|---|---|---|
| Profluorid group | Active comparator | 5% Sodium Fluoride varnish (Profluorid varnish) applied over white spot lesions on maxillary anterior teeth Receives: Combination Product: Sodium Fluoride with CPP-ACP varnish; Combination Product: sodium fluoride with ACP varnish |
| Enamel Pro | Experimental | Sodium Fluoride with ACP varnish (Enamel Pro varnish) applied over white spot lesions on maxillary anterior teeth Receives: Combination Product: Sodium Fluoride with CPP-ACP varnish; Drug: 5% Sodium Fluoride Varnish |
| MI varnish | Experimental | Sodium Fluoride with CPP-ACP varnish (MI varnish) applied over white spot lesions on maxillary anterior teeth Receives: Combination Product: sodium fluoride with ACP varnish; Drug: 5% Sodium Fluoride Varnish |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dimension and Activity of white spot lesions.
The dimension of white spot lesions were measured with photographs using Adobe photoshop software. After prolonged air drying of 5 sec, the activity of white spot lesions were visualized using CPITN probe
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2017
- Study start21 Mar 2016
- Primary completion24 Dec 2016
- Study completion17 Mar 2017
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 ChildStudies 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
- Model description
- The study model involves three groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indira Gandhi Institute of Dental Science
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DR.S.RADHA, Indira Gandhi Institute of Dental Science
- Investigators
- Kayalvizhi Gurusamy, MDS, Study director, IGIDS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03360266
- Sponsor's protocol ID
- IIGIDSIIRB2015 NDP20PGRSPPD
- Status last verified
- Nov 2017
- First submitted
- 30 Oct 2017
- Last updated
- 4 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Radha S, Kayalvizhi G, Adimoulame S, Prathima GS, Muthusamy K, Ezhumalai G, Jagadesaan N. Comparative Evaluation of the Remineralizing Efficacy of Fluoride Varnish and its Combination Varnishes on White Spot Lesions in Children with ECC: A Randomized Clinical Trial. Int J Clin Pediatr Dent. 2020 Jul-Aug;13(4):311-317. doi: 10.5005/jp-journals-10005-1673.
PubMed 33149400
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Remineralizing Efficacy of Fluoride Varnish and Its Combination Varnishes on White Spot Lesions in Children With ECC: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03360266
- Acronym / sponsor ID
- IIGIDSIIRB2015 NDP20PGRSPPD
- Conditions
- Child, Early Childhood Caries
- Keywords
- remineralization, fluoride varnish
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Indira Gandhi Institute of Dental ScienceUniversity, hospital or other
- Study start
- 21 Mar 2016 (actual)
- Primary completion
- 24 Dec 2016 (actual)
- Study completion
- 17 Mar 2017 (actual)
- First posted
- 4 Dec 2017 (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 remineralizing efficacy of 3 fluoride varnishes were assessed in children with white spot lesion under 6 years of age ( children with early childhood caries)
Detailed description
Early childhood caries (ECC) is the presence of 1 or more decayed (Non - Cavitated or Cavitated lesions), missing (due to caries) or filled tooth surface in any primary tooth in a child of 71 months of age or younger. In children younger than 3 years of age, any sign of smooth-surface caries is indicative of severe early childhood caries (S-ECC). It is a virulent form of caries, which develops on smooth surfaces and progresses rapidly. In children aged 12 to 30 months it initially affects the maxillary primary incisors and first primary molars, reflecting the pattern of eruption.
In ECC, the first clinical observation of demineralization in enamel is the white spot lesion, which is characterized by enamel demineralization of the subsurface, with increasing porosity due to the removal of minerals into the outer surface. At this stage, the caries lesion is usually reversible.
In young children, remineralization can be achieved by Non- invasive methods that are very effective. Fluoride prevents the caries process, leading to the formation of less soluble fluorapatite crystals. Among them, Topical fluorides are the most respected regimen. On application of topical fluorides to the teeth, calcium fluoride-like globules are formed on the tooth surface. These globules are effective mineral reservoirs that help prevent demineralization and promote remineralization by releasing calcium, phosphate and fluoride following acid attacks.
American Academy of Pediatric Dentistry (AAPD) recommends fluoride varnish in children. Randomized control trials have found it to be efficacious in primary teeth. Fluoride varnish can reverse or arrest caries lesions as well as prevent demineralization process of an incipient caries/white spot lesion, when combined with other preventive measures such as oral hygiene instructions \& diet counseling.Children at increased caries risk should receive a professional fluoride treatment at least every six months. There is evidence from randomized controlled trials and meta-analyses that professionally applied topical fluoride treatments as five percent sodium fluoride varnish or 1.23 percent fluoride gel preparations are efficacious in reducing caries in children at caries risk.
Fluoride varnish works by increasing the concentration of fluoride in the outer surface of teeth, thereby enhancing fluoride uptake during early stages of demineralization. The varnish hardens on the tooth as soon as it contacts saliva, allowing the high concentration of fluoride to be in contact with tooth enamel for an extended period of time This is a much longer exposure compared to other high-dose topical fluorides such as gels or foams, with less risk of fluorosis even in children younger than 6 years.
It has been observed from the literature review that only invitro studies and few clinical studies have been done in treating WSL in orthodontic patients using these combination varnishes. To our Knowledge, no clinical studies has assessed its efficacy and compared the effectiveness of these combination varnishes in remineralising white spot lesions of ECC in young children. Thus, this study was planned to compare the remineralizing efficiency of fluoride varnish with a combination of fluoride and calcium phosphate varnishes on white spot lesions in smooth surfaces of primary anterior teeth of children with ECC.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- The study model involves three groups
| Arm | Type | Receives |
|---|---|---|
| Profluorid group | Active comparator | Combination Product: Sodium Fluoride with CPP-ACP varnish, Combination Product: sodium fluoride with ACP varnish5% Sodium Fluoride varnish (Profluorid varnish) applied over white spot lesions on maxillary anterior teeth |
| Enamel Pro | Experimental | Combination Product: Sodium Fluoride with CPP-ACP varnish, Drug: 5% Sodium Fluoride VarnishSodium Fluoride with ACP varnish (Enamel Pro varnish) applied over white spot lesions on maxillary anterior teeth |
| MI varnish | Experimental | Combination Product: sodium fluoride with ACP varnish, Drug: 5% Sodium Fluoride VarnishSodium Fluoride with CPP-ACP varnish (MI varnish) applied over white spot lesions on maxillary anterior teeth |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Preschool children with ECC.
- Children with active white spot lesions on labial surface of 1 or more primary maxillary anterior teeth.
- Children whose parents signed the informed consent form/willing to participate in the study.
- Apart from fluoride varnish and fluoridated tooth paste, subjects exposed to no other form of fluoride were included.
Key exclusion criteria (4 listed)
- Preschool children with cavitated lesions on primary maxillary anterior teeth.
- Developmental enamel alterations (hypoplasia, fluorosis).
- Children with systemic diseases.
- Children with allergy to milk products.
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 |
|---|---|---|
| Sodium Fluoride with CPP-ACP varnishAlso: MI varnishfor children with ECC, this varnish effectively remineralizes the white spot lesion | Combination product | Enamel Pro, Profluorid group |
| sodium fluoride with ACP varnishAlso: Enamel Profor children with ECC, this varnish effectively remineralizes the white spot lesion | Combination product | MI varnish, Profluorid group |
| 5% Sodium Fluoride VarnishAlso: Profluoridffor children with ECC, this varnish effectively remineralizes the white spot lesion | Drug | Enamel Pro, MI varnish |
Primary outcome
Dimension and Activity of white spot lesions.
Time frame: 6 months
The dimension of white spot lesions were measured with photographs using Adobe photoshop software. After prolonged air drying of 5 sec, the activity of white spot lesions were visualized using CPITN probe
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 4 Dec 2017.
- Derived from this study: PubMed 33149400Radha S, Kayalvizhi G, Adimoulame S, Prathima GS, Muthusamy K, Ezhumalai G, Jagadesaan N. Comparative Evaluation of the Remineralizing Efficacy of Fluoride Varnish and its Combination Varnishes on White Spot Lesions in Children with ECC: A Randomized Clinical Trial. Int J Clin Pediatr Dent. 2020 Jul-Aug;13(4):311-317. doi: 10.5005/jp-journals-10005-1673.
- Individual participant dataSharing planned: Undecided
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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.
Kayalvizhi Gurusamy, MDS study director
IGIDS
Questions about this trial
What is this clinical trial studying?
A study testing Sodium Fluoride with CPP-ACP varnish, sodium fluoride with ACP varnish and 5% Sodium Fluoride Varnish in people with Child and Early Childhood Caries, run by Indira Gandhi Institute of Dental Science.
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 4 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 4 Dec 2017. 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. 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?
Dimension and Activity of white spot lesions. (time frame: 6 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 NCT03360266, 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 4 Dec 2017.