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

July 20, 2016 updated by: Ecem Ergin, Ege University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • İzmir, Turkey
        • Ege University School of Dentistry Department of Pedodontics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 16 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
QLF ( ∆F, ∆Q, lesion area)
Time Frame: Change baseline enamel fluorescence level at 6 weeks, 3 and 6 months.
remineralization level assesment
Change baseline enamel fluorescence level at 6 weeks, 3 and 6 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Salivary Streptococcus mutans and lactobacilli counts
Time Frame: baseline, after 6 weeks, 3 months and 6 months of the application
Microbiological assesment
baseline, after 6 weeks, 3 months and 6 months of the application
Spectrophotometer ( L, a, b)
Time Frame: baseline, after 6 weeks, 3 months and 6 months of the application
esthetic assesment
baseline, after 6 weeks, 3 months and 6 months of the application
Diagnodent
Time Frame: baseline
remineralization level assesment
baseline
Nyvad Caries Diagnostic Criteria index and ICDAS index
Time Frame: baseline
Evaluation of the state of the lesion
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ege University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

January 12, 2015

First Submitted That Met QC Criteria

January 14, 2015

First Posted (Estimate)

January 19, 2015

Study Record Updates

Last Update Posted (Estimate)

July 21, 2016

Last Update Submitted That Met QC Criteria

July 20, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • THESIS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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