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

Sponsor
Ege University (Other)
Overall Status
Completed
CT.gov ID
NCT02341872
Collaborator
(none)
32
1
4
35
0.9

Study Details

Study Description

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
  • Other: Clinpro White Varnish (fluoride + calcium varnish)
  • Other: Curodont Repair
N/A

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.

Study Design

Study Type:
Interventional
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 :
Aug 1, 2013
Actual Primary Completion Date :
Jul 1, 2016
Actual Study Completion Date :
Jul 1, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. QLF ( ∆F, ∆Q, lesion area) [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 [baseline, after 6 weeks, 3 months and 6 months of the application]

    Microbiological assesment

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

    esthetic assesment

  3. Diagnodent [baseline]

    remineralization level assesment

  4. Nyvad Caries Diagnostic Criteria index and ICDAS index [baseline]

    Evaluation of the state of the lesion

Eligibility Criteria

Criteria

Ages Eligible for Study:
10 Years to 18 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ege University School of Dentistry Department of Pedodontics İzmir Turkey

Sponsors and Collaborators

  • Ege University

Investigators

  • Principal Investigator: Ecem Ergin, Ege University
  • Study Director: Ece Eden, Ege University
  • Study Chair: Mustafa Ateş, Ege University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Ecem Ergin, Dt., Ege University
ClinicalTrials.gov Identifier:
NCT02341872
Other Study ID Numbers:
  • thesis
First Posted:
Jan 19, 2015
Last Update Posted:
Jul 21, 2016
Last Verified:
May 1, 2016
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Ecem Ergin, Dt., Ege University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 21, 2016