White Spot LesionsNCT02341872
Compare the Efficacy of the Remineralization Agents on the White Enamel Lesions
A study testing Clinpro White Varnish (fluoride + calcium varnish) and Curodont Repair in people with White Spot Lesions, run by Ege University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- White Spot Lesions
- What is being tested?
- Clinpro White Varnish (fluoride + calcium varnish) and Curodont Repair
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Aug 2013to Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- between 10-18 years olds
- healthy
- have one or more white spot lesions on her/his permanent teeth
Who cannot join
- have any health problem
- unsuitable age
- don't give approval for this study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ege University School of Dentistry Department of Pedodontics
Izmir, İzmir
About this study
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.
Read the 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)
- Group: Control group ( The investigators won't do any application , the oral hygiene konwledge will be given only.)
- Group: Fluoride + Calcium (TCP) (The investigators will do fluoride+ calcium varnish( Clinpro white varnish) application on white spot lesions)
- Group: Polipeptide solution (The investigators will do polipeptide ( Curodont repair) solution application on white spot lesions)
- 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.
- Conditions
- White Spot Lesions
- Being tested
- Clinpro White Varnish (fluoride + calcium varnish), Curodont Repair
- Keywords
- White spot lesions, remineralization, QLF, antibacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinpro White Varnish (fluoride + calcium varnish)Other
Clinpro White Varnish will be applied to the teeth with brush.
Curodont RepairOther
Curodont Repair solution be applied to the teeth in the form of drops
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | The investigators won't do any application , the oral hygiene konwledge will be given only. |
| Fluoride + Calcium varnish | Active comparator | The investigators will do fluoride+ calcium varnish( Clinpro White Varnish) application on white spot lesions. Receives: Other: Clinpro White Varnish (fluoride + calcium varnish) |
| Polipeptide solution | Experimental | The investigators will do polipeptide ( Curodont Repair) solution application on white spot lesions. Receives: Other: Curodont Repair |
| Fluoride + calcium + polipeptide | Experimental | The investigators will do polipeptide ( Curodont Repair) solution and fluoride + calcium varnish (Clinpro White Varnish) application on white spot lesions. Receives: Other: Clinpro White Varnish (fluoride + calcium varnish); Other: Curodont Repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
QLF ( ∆F, ∆Q, lesion area)
remineralization level assesment
Measured: Change baseline enamel fluorescence level at 6 weeks, 3 and 6 months.
Secondary outcomes (4)
Salivary Streptococcus mutans and lactobacilli counts
Microbiological assesment
Measured: baseline, after 6 weeks, 3 months and 6 months of the application
Spectrophotometer ( L, a, b)
esthetic assesment
Measured: baseline, after 6 weeks, 3 months and 6 months of the application
Diagnodent
remineralization level assesment
Measured: baseline
Nyvad Caries Diagnostic Criteria index and ICDAS index
Evaluation of the state of the lesion
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2015 (estimated)
- Study startAug 2013
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for White Spot LesionsStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ecem Ergin, Ege University
- Investigators
- Ecem Ergin, Principal investigator, Ege UniversityEce Eden, Study director, Ege UniversityMustafa Ateş, Study chair, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02341872
- Sponsor's protocol ID
- thesis
- Status last verified
- May 2016
- First submitted
- 12 Jan 2015
- Last updated
- 21 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Lelli M, Putignano A, Marchetti M, Foltran I, Mangani F, Procaccini M, Roveri N, Orsini G. Remineralization and repair of enamel surface by biomimetic Zn-carbonate hydroxyapatite containing toothpaste: a comparative in vivo study. Front Physiol. 2014 Sep 5;5:333. doi: 10.3389/fphys.2014.00333. eCollection 2014.
PubMed 25249980Kirkham J, Firth A, Vernals D, Boden N, Robinson C, Shore RC, Brookes SJ, Aggeli A. Self-assembling peptide scaffolds promote enamel remineralization. J Dent Res. 2007 May;86(5):426-30. doi: 10.1177/154405910708600507.
PubMed 17452562Beerens 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.
PubMed 25423022Oliveira 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.
PubMed 25260438Mehta 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.
PubMed 24552927Gomez 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.
PubMed 24481051Guven E, Eden E, Attin R, Firinciogullari EC. Remineralization of post-orthodontic white spot lesions with a fluoride varnish and a self-assembling P 11 - 4 peptides: a prospective in-vivo-study. Clin Oral Investig. 2024 Aug 3;28(8):464. doi: 10.1007/s00784-024-05865-2.
PubMed 39096337
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compare the Efficacy of the Remineralization Agents on the White Enamel Lesions
- ClinicalTrials.gov ID
- NCT02341872
- Acronym / sponsor ID
- thesis
- Conditions
- White Spot Lesions
- Keywords
- White spot lesions, remineralization, QLF, antibacterial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 19 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
- Group: Control group ( The investigators won't do any application , the oral hygiene konwledge will be given only.)
- Group: Fluoride + Calcium (TCP) (The investigators will do fluoride+ calcium varnish( Clinpro white varnish) application on white spot lesions)
- Group: Polipeptide solution (The investigators will do polipeptide ( Curodont repair) solution application on white spot lesions)
- 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –The investigators won't do any application , the oral hygiene konwledge will be given only. |
| Fluoride + Calcium varnish | Active comparator | Other: Clinpro White Varnish (fluoride + calcium varnish)The investigators will do fluoride+ calcium varnish( Clinpro White Varnish) application on white spot lesions. |
| Polipeptide solution | Experimental | Other: Curodont RepairThe investigators will do polipeptide ( Curodont Repair) solution application on white spot lesions. |
| Fluoride + calcium + polipeptide | Experimental | Other: Clinpro White Varnish (fluoride + calcium varnish), Other: Curodont RepairThe investigators will do polipeptide ( Curodont Repair) solution and fluoride + calcium varnish (Clinpro White Varnish) application on white spot lesions. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- between 10-18 years olds
- healthy
- have one or more white spot lesions on her/his permanent teeth
Key exclusion criteria (3 listed)
- have any health problem
- unsuitable age
- don't give approval for this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinpro White Varnish (fluoride + calcium varnish)Clinpro White Varnish will be applied to the teeth with brush. | Other | Fluoride + Calcium varnish, Fluoride + calcium + polipeptide |
| Curodont RepairCurodont Repair solution be applied to the teeth in the form of drops | Other | Fluoride + calcium + polipeptide, Polipeptide solution |
Primary outcome
QLF ( ∆F, ∆Q, lesion area)
Time frame: Change baseline enamel fluorescence level at 6 weeks, 3 and 6 months.
remineralization level assesment
4 secondary outcomes
Salivary Streptococcus mutans and lactobacilli counts
Time frame: 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
Diagnodent
Time frame: baseline
Nyvad Caries Diagnostic Criteria index and ICDAS index
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2016.
- Background: PubMed 25249980Lelli M, Putignano A, Marchetti M, Foltran I, Mangani F, Procaccini M, Roveri N, Orsini G. Remineralization and repair of enamel surface by biomimetic Zn-carbonate hydroxyapatite containing toothpaste: a comparative in vivo study. Front Physiol. 2014 Sep 5;5:333. doi: 10.3389/fphys.2014.00333. eCollection 2014.
- Background: PubMed 17452562Kirkham J, Firth A, Vernals D, Boden N, Robinson C, Shore RC, Brookes SJ, Aggeli A. Self-assembling peptide scaffolds promote enamel remineralization. J Dent Res. 2007 May;86(5):426-30. doi: 10.1177/154405910708600507.
- Background: PubMed 25423022Beerens 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.
- Background: PubMed 25260438Oliveira 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.
- Background: PubMed 24552927Mehta 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.
- Background: PubMed 24481051Gomez 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.
- Derived from this study: PubMed 39096337Guven E, Eden E, Attin R, Firinciogullari EC. Remineralization of post-orthodontic white spot lesions with a fluoride varnish and a self-assembling P 11 - 4 peptides: a prospective in-vivo-study. Clin Oral Investig. 2024 Aug 3;28(8):464. doi: 10.1007/s00784-024-05865-2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ecem Ergin principal investigator
Ege University
Ece Eden study director
Ege University
Mustafa Ateş study chair
Ege University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinpro White Varnish (fluoride + calcium varnish) and Curodont Repair in people with White Spot Lesions, run by Ege University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
QLF ( ∆F, ∆Q, lesion area) (time frame: Change baseline enamel fluorescence level at 6 weeks, 3 and 6 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02341872, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2016.