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Compare the Efficacy of the Remineralization Agents on the White Enamel Lesions

Compare the Efficacy of the Remineralization Agents on the White Enamel Lesions

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02341872
Enrollment
32
Registered
2015-01-19
Start date
2013-08-31
Completion date
2016-07-31
Last updated
2016-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

White Spot Lesions

Keywords

White spot lesions, remineralization, QLF, antibacterial

Brief summary

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.

Detailed description

The aim of this study is that evaluate the remineralizing and antibacterial effects of the different remineralization agents. Initiative caries lesions named as white spot lesions and these lesions are localized at enamel. Demineralization is occured but cavitations aren't seen at this stage. It is important to control at this stage with remineralization agents because of the minimally invasive approach. Fluoride varnish or polipeptide containing agents alone or combination using effects on remineralization, esthetic and bacterial counts will be evaluated with Quantitive Light Fluorescence , Diagnodent (Cavo-Diagnodent), Spectrophotometer (Vita Easy Shade) devices and microbiological assessment at laboratory. The investigators will choose and include in our study that who come to the Ege University Faculty of Dentistry pediatric department, between 10-18 years olds, healthy and have one or more white spot lesions on her/his permanent teeth. 32 volunteer who have inclusion criteria will be put into pratice. 32 volunteer divided into 4 groups for different applications. We will tell each volunteer that they must brush their teeth twice a day with fluoride dentifrice ( the investigators will give them 1400 ppm fluoride containing fluoride dentifrice) 1. Group: Control group ( The investigators won't do any application , the oral hygiene konwledge will be given only.) 2. Group: Fluoride + Calcium (TCP) (The investigators will do fluoride+ calcium varnish( Clinpro white varnish) application on white spot lesions) 3. Group: Polipeptide solution (The investigators will do polipeptide ( Curodont repair) solution application on white spot lesions) 4. Group: \[Fluoride + calcium varnish\] + polipeptide solution combination ( The investigators will do polipeptide ( Curodont repair) solution and fluoride + calcium varnish (Clinpro white varnish) application on white spot lesions) First day,the investigators will collect stimulated saliva from each volunteer before any application. Saliva samples will transport to the microbiology laboratory. After any application 6 weeks, 3 months and 6 months later we will collect stimulated saliva again for microbiological assessment. Nyvad Caries Diagnostic Criteria , ICDAS indexes will be used to make the follow-up of lesions at baseline and 6 months after the application. Plaque index (Silness & Löe , 1964) and bleeding index (Ainamo&Bay ,1976) will be used to assess oral hygiene every visit. The investigators will use QLF,Diagnodent devices will be used at beginning for evaluate the demineralization level and after applications 6 weeks, 3 months and 6 months later used for evaluate the remineralization level. In addition for determine about esthetic results the investigators will use spectrophotometer (Vita Easy Shade) device at beginning, 6 weeks, 3 months and 6 months later.

Interventions

OTHERClinpro White Varnish (fluoride + calcium varnish)

Clinpro White Varnish will be applied to the teeth with brush.

Curodont Repair solution be applied to the teeth in the form of drops

Sponsors

Ege University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
10 Years to 18 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
QLF ( ∆F, ∆Q, lesion area)Change baseline enamel fluorescence level at 6 weeks, 3 and 6 months.remineralization level assesment

Secondary

MeasureTime frameDescription
Salivary Streptococcus mutans and lactobacilli countsbaseline, after 6 weeks, 3 months and 6 months of the applicationMicrobiological assesment
Spectrophotometer ( L, a, b)baseline, after 6 weeks, 3 months and 6 months of the applicationesthetic assesment
Diagnodentbaselineremineralization level assesment
Nyvad Caries Diagnostic Criteria index and ICDAS indexbaselineEvaluation of the state of the lesion

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026