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

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ClinicalTrials.gov Identifier: NCT02341872
Recruitment Status : Completed
First Posted : January 19, 2015
Last Update Posted : July 21, 2016
Sponsor:
Information provided by (Responsible Party):
Ecem Ergin, Ege University

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.

Condition or disease Intervention/treatment Phase
White Spot Lesions Other: Clinpro White Varnish (fluoride + calcium varnish) Other: Curodont Repair Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Compare the Efficacy of the Remineralization Agents on the White Enamel Lesions
Study Start Date : August 2013
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rashes
Drug Information available for: Fluoride

Arm Intervention/treatment
No Intervention: Control
The investigators won't do any application , the oral hygiene konwledge will be given only.
Active Comparator: Fluoride + Calcium varnish
The investigators will do fluoride+ calcium varnish( Clinpro White Varnish) application on white spot lesions.
Other: Clinpro White Varnish (fluoride + calcium varnish)
Clinpro White Varnish will be applied to the teeth with brush.

Experimental: Polipeptide solution
The investigators will do polipeptide ( Curodont Repair) solution application on white spot lesions.
Other: Curodont Repair
Curodont Repair solution be applied to the teeth in the form of drops

Experimental: Fluoride + calcium + polipeptide
The investigators will do polipeptide ( Curodont Repair) solution and fluoride + calcium varnish (Clinpro White Varnish) application on white spot lesions.
Other: Clinpro White Varnish (fluoride + calcium varnish)
Clinpro White Varnish will be applied to the teeth with brush.

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




Primary Outcome Measures :
  1. QLF ( ∆F, ∆Q, lesion area) [ Time Frame: Change baseline enamel fluorescence level at 6 weeks, 3 and 6 months. ]
    remineralization level assesment


Secondary Outcome Measures :
  1. Salivary Streptococcus mutans and lactobacilli counts [ Time Frame: baseline, after 6 weeks, 3 months and 6 months of the application ]
    Microbiological assesment

  2. Spectrophotometer ( L, a, b) [ Time Frame: baseline, after 6 weeks, 3 months and 6 months of the application ]
    esthetic assesment

  3. Diagnodent [ Time Frame: baseline ]
    remineralization level assesment

  4. Nyvad Caries Diagnostic Criteria index and ICDAS index [ Time Frame: baseline ]
    Evaluation of the state of the lesion



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02341872


Locations
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Turkey
Ege University School of Dentistry Department of Pedodontics
İzmir, Turkey
Sponsors and Collaborators
Ege University
Investigators
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Principal Investigator: Ecem Ergin Ege University
Study Director: Ece Eden Ege University
Study Chair: Mustafa Ateş Ege University
Publications:

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Responsible Party: Ecem Ergin, Dt., Ege University
ClinicalTrials.gov Identifier: NCT02341872    
Other Study ID Numbers: thesis
First Posted: January 19, 2015    Key Record Dates
Last Update Posted: July 21, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Ecem Ergin, Ege University:
White spot lesions
remineralization
QLF
antibacterial
Additional relevant MeSH terms:
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Calcium
Fluorides
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Cariostatic Agents
Protective Agents