White Spot Lesions Clinical Trial
Official title:
Compare the Efficacy of the Remineralization Agents on the White Enamel Lesions
Verified date | May 2016 |
Source | Ege University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Turkey: Ethics CommitteeTurkey: Ministry of Health |
Study type | Interventional |
The purpose of this study is to determine whether Fluoride varnish + calcium (Clinpro White Varnish) and polipeptide solution (Curodont Repair) are effective in the treatment of remineralization therapy. The investigators will diagnose their alone or in combination effects on white spot lesions. Aesthetics (tooth-colored), remineralization, microbiological effects will be evaluated separately. Spectrophotometer (Vita Easy Shade) , Quantitative Light Fluorescence (QLF), Diagnodent(Cavo Diagnodent) and culture methods in microbiology laboratories are used for aesthetic, remineralization and microbiological assessments. The measurements will be made baseline, 6 weeks, 3 months and 6 months later after the applications and recorded.
Status | Completed |
Enrollment | 32 |
Est. completion date | July 2016 |
Est. primary completion date | July 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 10 Years to 18 Years |
Eligibility |
Inclusion Criteria: - between 10-18 years olds - healthy - have one or more white spot lesions on her/his permanent teeth Exclusion Criteria: - have any health problem - unsuitable age - don't give approval for this study |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Turkey | Ege University School of Dentistry Department of Pedodontics | Izmir |
Lead Sponsor | Collaborator |
---|---|
Ege University |
Turkey,
Beerens MW, Boekitwetan F, van der Veen MH, ten Cate JM. White spot lesions after orthodontic treatment assessed by clinical photographs and by quantitative light-induced fluorescence imaging; a retrospective study. Acta Odontol Scand. 2015 Aug;73(6):441-6. doi: 10.3109/00016357.2014.980846. Epub 2014 Nov 25. — View Citation
Gomez J, Pretty IA, Santarpia RP 3rd, Cantore B, Rege A, Petrou I, Ellwood RP. Quantitative light-induced fluorescence to measure enamel remineralization in vitro. Caries Res. 2014;48(3):223-7. doi: 10.1159/000354655. Epub 2014 Jan 29. — View Citation
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Mehta R, Nandlal B, Prashanth S. Comparative evaluation of remineralization potential of casein phosphopeptide-amorphous calcium phosphate and casein phosphopeptide-amorphous calcium phosphate fluoride on artificial enamel white spot lesion: an in vitro light fluorescence study. Indian J Dent Res. 2013 Nov-Dec;24(6):681-9. doi: 10.4103/0970-9290.127610. — View Citation
Oliveira GM, Ritter AV, Heymann HO, Swift E Jr, Donovan T, Brock G, Wright T. Remineralization effect of CPP-ACP and fluoride for white spot lesions in vitro. J Dent. 2014 Dec;42(12):1592-602. doi: 10.1016/j.jdent.2014.09.004. Epub 2014 Sep 23. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | QLF ( ?F, ?Q, lesion area) | remineralization level assesment | Change baseline enamel fluorescence level at 6 weeks, 3 and 6 months. | No |
Secondary | Salivary Streptococcus mutans and lactobacilli counts | Microbiological assesment | baseline, after 6 weeks, 3 months and 6 months of the application | No |
Secondary | Spectrophotometer ( L, a, b) | esthetic assesment | baseline, after 6 weeks, 3 months and 6 months of the application | No |
Secondary | Diagnodent | remineralization level assesment | baseline | No |
Secondary | Nyvad Caries Diagnostic Criteria index and ICDAS index | Evaluation of the state of the lesion | baseline | No |
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