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Effect of Curodont Repair on Color Change of White Spot Lesions

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ClinicalTrials.gov Identifier: NCT02913885
Recruitment Status : Unknown
Verified September 2016 by Aalaa Mohamed Nabil, Cairo University.
Recruitment status was:  Not yet recruiting
First Posted : September 26, 2016
Last Update Posted : September 26, 2016
Sponsor:
Information provided by (Responsible Party):
Aalaa Mohamed Nabil, Cairo University

Brief Summary:
The aim of this study is to compare the effect of color change between remineralizing agent and guided enamel regeneration in treatment of white spot lesion after orthodontic treatments

Condition or disease Intervention/treatment Phase
White Spot Lesion Drug: Curodont Repair Drug: fluoride varnish Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparative Study Using Biomimetic Remineralization Versus Fluoride Varnish In Management Of White Spot Lesion In Post Orthodontic Treated Patient: (Split Mouth Technique ) A Randomized Clinical Trial
Study Start Date : January 2017
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rashes

Arm Intervention/treatment
Active Comparator: Group 2
curodont repair is a biomimetic regeneration scaffold for remineralization
Drug: Curodont Repair
composed of biomimetic regeneration scaffold self-assembling peptides (P11-4) used for remineralization
Other Name: CURODONT™ REPAIR,Credentis, Switzerland

Drug: fluoride varnish
fluoride inhibit the progression of white spot lesion
Other Name: 2.26% F, Duraphat, WoelmPharma GmbH, Germany

Experimental: Group 1
fluoride varnish inhibit progression of white spot lesion
Drug: Curodont Repair
composed of biomimetic regeneration scaffold self-assembling peptides (P11-4) used for remineralization
Other Name: CURODONT™ REPAIR,Credentis, Switzerland

Drug: fluoride varnish
fluoride inhibit the progression of white spot lesion
Other Name: 2.26% F, Duraphat, WoelmPharma GmbH, Germany




Primary Outcome Measures :
  1. change in patient satisfaction [ Time Frame: before, after 3 and 6 months ]
    using visual analogue scale from 0-100 (0= not satisfied , 100= totally satisfied)


Secondary Outcome Measures :
  1. change in color shade [ Time Frame: before, after 3 and 6 months ]
    will use vita easy shade devise



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Ages Eligible for Study:   12 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. No systemic disease.
  2. Has completed fixed orthodontic treatment, brackets debonded.
  3. Has at least two teeth with white spot lesion.
  4. Has received conventional periodontal therapy after orthodontic treatment.
  5. Between the ages of 12 and 25 years of age

Exclusion Criteria:

  1. presence of enamel hypoplasia or dental fluorosis.
  2. presence of tetracycline pigmentation.
  3. periodontal pocketing of 3mm or greater.
  4. taking antibiotics.
  5. presence of carious cavities.
  6. allergy to fluoride gel / varnish being used in study.
  7. Subjects who had evidence of reduced salivary flow or significant tooth wear

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): NCT02913885


Contacts
Contact: aalaa M. Nabil, Master 01229709666 aalaanabil@gmail.com
Contact: rasha haridy, phD 01004709947 rh_haridy@hotmail.com

Sponsors and Collaborators
Cairo University

Responsible Party: Aalaa Mohamed Nabil, assistant lecturer, conservative Dentistry Department MTI university, Cairo University
ClinicalTrials.gov Identifier: NCT02913885     History of Changes
Other Study ID Numbers: CEBD-CU-2016-09-199
First Posted: September 26, 2016    Key Record Dates
Last Update Posted: September 26, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Fluorides
Fluorides, Topical
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs