Evaluation of Remineralizing Efficacy of Combination Varnishes on White Spot Lesions in ECC Children
NCT ID: NCT03360266
Last Updated: 2017-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
60 participants
INTERVENTIONAL
2016-03-21
2017-03-17
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Profluorid group
5% Sodium Fluoride varnish (Profluorid varnish) applied over white spot lesions on maxillary anterior teeth
Sodium Fluoride with CPP-ACP varnish
for children with ECC, this varnish effectively remineralizes the white spot lesion
sodium fluoride with ACP varnish
for children with ECC, this varnish effectively remineralizes the white spot lesion
Enamel Pro
Sodium Fluoride with ACP varnish (Enamel Pro varnish) applied over white spot lesions on maxillary anterior teeth
Sodium Fluoride with CPP-ACP varnish
for children with ECC, this varnish effectively remineralizes the white spot lesion
5% Sodium Fluoride Varnish
ffor children with ECC, this varnish effectively remineralizes the white spot lesion
MI varnish
Sodium Fluoride with CPP-ACP varnish (MI varnish) applied over white spot lesions on maxillary anterior teeth
sodium fluoride with ACP varnish
for children with ECC, this varnish effectively remineralizes the white spot lesion
5% Sodium Fluoride Varnish
ffor children with ECC, this varnish effectively remineralizes the white spot lesion
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Sodium Fluoride with CPP-ACP varnish
for children with ECC, this varnish effectively remineralizes the white spot lesion
sodium fluoride with ACP varnish
for children with ECC, this varnish effectively remineralizes the white spot lesion
5% Sodium Fluoride Varnish
ffor children with ECC, this varnish effectively remineralizes the white spot lesion
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Children with active white spot lesions on labial surface of 1 or more primary maxillary anterior teeth.
3. Children whose parents signed the informed consent form/willing to participate in the study.
4. Apart from fluoride varnish and fluoridated tooth paste, subjects exposed to no other form of fluoride were included.
Exclusion Criteria
2. Developmental enamel alterations (hypoplasia, fluorosis).
3. Children with systemic diseases.
4. Children with allergy to milk products.
3 Years
6 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Indira Gandhi Institute of Dental Science
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
DR.S.RADHA
Principal investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Kayalvizhi Gurusamy, MDS
Role: STUDY_DIRECTOR
IGIDS
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IIGIDSIIRB2015 NDP20PGRSPPD
Identifier Type: -
Identifier Source: org_study_id