Fluoride Therapies on Hypersensitive Carious Lesions in Primary Teeth
NCT ID: NCT04804423
Last Updated: 2021-05-06
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
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COMPLETED
PHASE2/PHASE3
30 participants
INTERVENTIONAL
2020-01-13
2021-04-01
Brief Summary
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Detailed Description
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Eligibility to the study will be determined by a single trained examiner through clinical findings of caries activity according to Bjørndal criteria, and reported history of hypersensitivity symptoms obtained from the parent/caregiver of the participant, followed by hypersensitivity confirmatory test using a triple syringe air blast on the exposed surface of the carious lesion to allocate areas with suspected dentin hypersensitivity.
After clinical examination and obtainment of an informed consent, eligible children will be treated with fluoride varnish application (Duraphat®), or silver fluoride and potassium iodide application (Riva Star®) according to manufacturer's instructions.The participant's behavior shall be evaluated at the beginning, during and after treatment. Plaque Index (API) and Papillary Bleeding Index (PBI) will also be assessed prior to treatment and at the 3-months mark. Procedures will be performed by six different dentists (four pediatric specialists and two post-graduate pediatric dentistry students), all of whom were briefed on the study protocol and received instructions in carrying in the interventions according to the manufacturer's guide, and their technical opinions regarding the performed procedures will be obtained following the procedure. Follow up examinations after 3 months will be done by a single examiner. Only one tooth per child will be included in the analysis.
Data and information of this study will be recorded, handled, and stored in an organized and secure way, to allow its accurate reporting, interpretation, and verification. To assure confidentiality of clinical records, an unambiguous subject identification code will be used. Patients who are no longer willing to continue in the study will have the right to quit at any time without any penalty.
All variables will be statistically analyzed using descriptive statistics, plots, and tests of normality. Means and standard deviations (SD) will be calculated for all quantitative variables, while frequencies and percentages will be calculated for categorical variables.
Comparison between the two study groups will utilize independent samples t-test for quantitative normally distributed variables, and Mann-Whitney U for quantitative non-normally distributed variables and qualitative ordinal variables. Chi-squared and Fisher exact tests will be performed for comparing qualitative nominal variables between the two study groups. Comparing the baseline and follow-up shall be done using paired t-test when the variable is normally distributed, and Wilcoxon signed rank test when the variable is not normally distributed. For comparing lesion activity before and after treatment, McNemar test will be used and Friedman test for comparing the children's behavior at 3 different time points (before, during and after treatment).
A Significance will be set at p\<0.05. Data will be analyzed using IBM SPSS statistical software for windows (version 25).
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Fluoride varnish (Duraphat®)
Fluoride varnish application is recommended by the German National Health System for managing hypersensitivity and dental caries. Sodium fluoride varnish (Duraphat®) will be applied on hypersensitive active carious lesions (ICDAS 5).
Sodium fluoride varnish (generic name; Duraphat®)
22,600 ppm sodium fluoride varnish will be applied on the surface of the affected hypersensitive active carious lesions.
Silver fluoride and potassium iodide (Riva Star®)
Silver fluoride and potassium iodide (Riva Star®) is primarily indicated for relieving hypersensitivity will be applied on hypersensitive active carious lesions (ICDAS 5) following isolation of the affected teeth and according to manufacturer's instructions.
38% Silver Fluoride and Potassium Iodide solution (generic name; Riva Star®)
38% silver fluoride will be applied to the surface of the isolated hypersensitive carious lesion followed by application of potassium iodide solution and according to manufacturer's instructions.
Interventions
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38% Silver Fluoride and Potassium Iodide solution (generic name; Riva Star®)
38% silver fluoride will be applied to the surface of the isolated hypersensitive carious lesion followed by application of potassium iodide solution and according to manufacturer's instructions.
Sodium fluoride varnish (generic name; Duraphat®)
22,600 ppm sodium fluoride varnish will be applied on the surface of the affected hypersensitive active carious lesions.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Healthy children aged 2-5 years.
* Not using any desensitizer for 1-month prior the study.
* Willing to be examined.
Exclusion Criteria
* Teeth with signs or symptoms of irreversible pulpitis.
* Patients with any systemic disease requiring special considerations during their dental treatment.
* Parents/children who declined to participate in the study.
2 Years
5 Years
ALL
No
Sponsors
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SDI Limited
UNKNOWN
University Medicine Greifswald
OTHER
Responsible Party
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Principal Investigators
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Mohamed H Abudrya, BDS, MSc.
Role: PRINCIPAL_INVESTIGATOR
The Department of Preventive and Pediatric Dentistry, University of Greifswald
Locations
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The Department of Preventive and Pediatric Dentistry, University of Greifswald
Greifswald, Mecklenburg-Vorpommern, Germany
Countries
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References
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West N, Seong J, Davies M. Dentine hypersensitivity. Monogr Oral Sci. 2014;25:108-22. doi: 10.1159/000360749. Epub 2014 Jun 26.
Crystal YO, Janal MN, Hamilton DS, Niederman R. Parental perceptions and acceptance of silver diamine fluoride staining. J Am Dent Assoc. 2017 Jul;148(7):510-518.e4. doi: 10.1016/j.adaj.2017.03.013. Epub 2017 Apr 27.
Use of Silver Diamine Fluoride for Dental Caries Management in Children and Adolescents, Including Those with Special Health Care Needs. Pediatr Dent. 2018 Oct 15;40(6):152-161.
Gao SS, Zhang S, Mei ML, Lo EC, Chu CH. Caries remineralisation and arresting effect in children by professionally applied fluoride treatment - a systematic review. BMC Oral Health. 2016 Feb 1;16:12. doi: 10.1186/s12903-016-0171-6.
Machiulskiene V, Campus G, Carvalho JC, Dige I, Ekstrand KR, Jablonski-Momeni A, Maltz M, Manton DJ, Martignon S, Martinez-Mier EA, Pitts NB, Schulte AG, Splieth CH, Tenuta LMA, Ferreira Zandona A, Nyvad B. Terminology of Dental Caries and Dental Caries Management: Consensus Report of a Workshop Organized by ORCA and Cariology Research Group of IADR. Caries Res. 2020;54(1):7-14. doi: 10.1159/000503309. Epub 2019 Oct 7.
Poulsen S, Errboe M, Hovgaard O, Worthington HW. Potassium nitrate toothpaste for dentine hypersensitivity. Cochrane Database Syst Rev. 2001;(2):CD001476. doi: 10.1002/14651858.CD001476.
Splieth CH, Tachou A. Epidemiology of dentin hypersensitivity. Clin Oral Investig. 2013 Mar;17 Suppl 1(Suppl 1):S3-8. doi: 10.1007/s00784-012-0889-8. Epub 2012 Dec 7.
Santamaria RM, Innes NPT, Machiulskiene V, Schmoeckel J, Alkilzy M, Splieth CH. Alternative Caries Management Options for Primary Molars: 2.5-Year Outcomes of a Randomised Clinical Trial. Caries Res. 2017;51(6):605-614. doi: 10.1159/000477855. Epub 2017 Dec 20.
Santamaria RM, Abudrya MH, Gul G, Mourad MS, Gomez GF, Zandona AGF. How to Intervene in the Caries Process: Dentin Caries in Primary Teeth. Caries Res. 2020;54(4):306-323. doi: 10.1159/000508899. Epub 2020 Aug 27.
Related Links
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DA: Food and Drug Administration. Diammine Silver Fluoride Dental Hypersensitivity Varnish.
Other Identifiers
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ID-KinderZZMK-2020
Identifier Type: -
Identifier Source: org_study_id
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