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

NCT02341872 | Completed DMC

• 1 other identifier: thesis
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

White Spot Lesions

Keywords

White spot lesions; remineralization; QLF; antibacterial

Outcome Measures

Primary Outcomes (1)

• QLF ( ∆F, ∆Q, lesion area)

  remineralization level assesment

  Change baseline enamel fluorescence level at 6 weeks, 3 and 6 months.

Secondary Outcomes (4)

• Salivary Streptococcus mutans and lactobacilli counts

  baseline, after 6 weeks, 3 months and 6 months of the application

• Spectrophotometer ( L, a, b)

  baseline, after 6 weeks, 3 months and 6 months of the application

• Diagnodent

  baseline

• Nyvad Caries Diagnostic Criteria index and ICDAS index

  baseline

Study Arms (4)

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.

Other: Clinpro White Varnish (fluoride + calcium varnish)

Polipeptide solution

EXPERIMENTAL

The investigators will do polipeptide ( Curodont Repair) solution application on white spot lesions.

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.

Other: Clinpro White Varnish (fluoride + calcium varnish); Other: Curodont Repair

Interventions

Clinpro White Varnish (fluoride + calcium varnish) OTHER

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

Fluoride + Calcium varnish; Fluoride + calcium + polipeptide

Curodont Repair OTHER

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

Fluoride + calcium + polipeptide; Polipeptide solution

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• between 10-18 years olds
• healthy
• have one or more white spot lesions on her/his permanent teeth

You may not qualify if:

• have any health problem
• unsuitable age
• don't give approval for this study

Sponsors & Collaborators

• Ege University: lead

Study Sites (1)

Ege University School of Dentistry Department of Pedodontics

Izmir, İzmir, Turkey (Türkiye)

Location

Related Publications (6)

• 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.

  PMID: 25249980 BACKGROUND

• Kirkham 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.

  PMID: 17452562 BACKGROUND

• Beerens 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.

  PMID: 25423022 BACKGROUND

• Oliveira 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.

  PMID: 25260438 BACKGROUND

• Mehta 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.

  PMID: 24552927 BACKGROUND

• Gomez 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.

  PMID: 24481051 BACKGROUND

MeSH Terms

Interventions

Fluorides

Intervention Hierarchy (Ancestors)

Anions; Ions; Electrolytes; Inorganic Chemicals; Hydrofluoric Acid; Fluorine Compounds

Study Officials

• Ecem Ergin

  Ege University

  PRINCIPAL INVESTIGATOR

• Ece Eden

  Ege University

  STUDY DIRECTOR

• Mustafa Ateş

  Ege University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dt.

Study Record Dates

• First Submitted: January 12, 2015
• First Posted: January 19, 2015
• Study Start: August 1, 2013
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: July 21, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)