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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

Tracking Information
First Submitted Date  ICMJE September 21, 2016
First Posted Date  ICMJE September 26, 2016
Last Update Posted Date September 26, 2016
Study Start Date  ICMJE January 2017
Estimated Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 23, 2016)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 23, 2016)
change in color shade [ Time Frame: before, after 3 and 6 months ]
will use vita easy shade devise
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Curodont Repair on Color Change of White Spot Lesions
Official Title  ICMJE 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
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
Detailed Description

Roles and responsibilities:

  1. Aalaa Mohamed Nabil Amin Abdullatif (A.N.) Operator, data enterer and corresponding author; Assistant lecturer, Conservative Dentistry Department, ModernTechnology University, Egypt.
  2. Mohamed Riad (M.R) Main supervisor, data monitoring, auditing Professor, Conservative Dentistry Department, Faculty of Oral and Dental Medicine, Cairo University, Egypt.
  3. Rasha Haridy (R.H.) Co-supervisor, data entry and auditing; Conservative Dentistry Department, Faculty of Oral and Dental Medicine, Cairo University, Egypt.
  4. Ahmed Refaat Mohamed (A.R.) Outcome assessors and data collection; Lecturers, Conservative Dentistry Department, Faculty of Oral and Dental Medicine, Cairo University, Egypt.
  5. Heba fathy (H.F) Outcome assessors and data collection; Assistant lecturer,, Conservative Dentistry Department, Faculty of Oral and Dental Medicine, Cairo University, Egypt.
  6. Ahmed Mamdouh Ahmed (A.M.) Base line data collection, recruitment, sequence generation, allocation concealment, patient retention and taking participants' consents; Resident, Conservative Dentistry Department, Faculty of Oral and Dental Medicine, Cairo University, Egypt.
  7. Eman Desouky (E.D.) Sample size calculation; Statistician, Faculty of Oral and Dental Medicine, Cairo University, Egypt.
  8. Evidence Based Dentistry Committee (CEBD) Help in reporting study protocol following SPIRIT guidelines; Faculty of Oral and Dental Medicine, Cairo University, Egypt.
  9. Research Ethics Committee (CREC) Protocol reviewer of the clinical trial in order to protect the right, safety, dignity and well-being of the participants; Faculty of Oral and Dental Medicine, Cairo University, Egypt.

1-Intervention: A.N. will treat the lesion with 2 % NaOCl for 20 sec, then rinsed and dried. A.N. will etch the lesion with 35 % Phosphoric acid for 20 sec to open up the pores to the subsurface lesion and sub¬sequently rinsed with water for 20 sec and air-dried. A.N. will apply (CURODONT™ REPAIR,Credentis, Switzerland) for two to three minutes. A.N. will advise the patients to rinse the quadrant containing the treated teeth using chlorhexidine mouthwash (Corsodyl, Herrenberg, Germany) until Day 4 and avoid teeth brushing. At D4, A.N. will ask the patients to use a soft tooth brush and tooth paste until Day 8. At this point they will be reverted to their normal oral hygiene procedures.

2-Comparator: A.N. will apply (2.26% F, Duraphat, WoelmPharma,Gesellschaft mit beschränkter Haftung, Germany). onto the tooth surfaces with White Spot Lesions using a brush, with the applicator dabbed repeatedly onto the tooth surface without contacting soft tissues. After a few minutes, a thin and clear layer is formed. A.N. will advise the patients not to brush their teeth or chew food for at least 4 hrs after treatment; during this time, soft food and liquid might be consumed.

3-Outcomes:

  1. Patient satisfaction:

    H.F.& A.R will measure patient satisfaction using Visual Analogue Scale scores. The mean and standard deviation for the VAS scores of the patients recorded preoperatively, at the time of materials application, 3,6 months review for aesthetics

  2. Color change assessment:

H.F.& A.R will perform visual color evaluation using the Vita Easyshade Compact (Vita Zahnfabrik, Bad Sa¨ckingen,Germany).

The shade tab may now be measured by holding the probe tip at 90° to surface at the middle 1/3 of the tab, pressing the measurement button on the Hand Piece, and waiting until the Easyshade "beeps" to indicate successful completion of the measurement H.F.& A.R will hold the probe tip 90ᴼ to the WSL on tooth surface and pressing the measurement bottom on the hand piece and waiting until the easyshade beeps to indicate successful completion of the measurement , Three images will be captured for each tooth at each time point, and the average values for L* (lightness, achromatic color coordinate), a* (green/red coordinate), b* (blue/yellow coordinate), and the resultant color difference (ϪE*) over the three measurements will be calculated H.F.& A.R will perform the visual color assessments at baseline (T0) to record the color characteristics of the WSLs immediately after treatment, (T1) to record the color characteristics of the WSL after 3 months, (T2) to record the color characteristics of the WSL after 6 months. The instrumental color measurements will be performed using the Commission International de I'Eclariage (CIE) L*a*b* color notation system (CIELAB).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE White Spot Lesion
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: Group 2
    curodont repair is a biomimetic regeneration scaffold for remineralization
    Interventions:
    • Drug: Curodont Repair
    • Drug: fluoride varnish
  • Experimental: Group 1
    fluoride varnish inhibit progression of white spot lesion
    Interventions:
    • Drug: Curodont Repair
    • Drug: fluoride varnish
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 23, 2016)
64
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2017
Estimated Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 25 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02913885
Other Study ID Numbers  ICMJE CEBD-CU-2016-09-199
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Aalaa Mohamed Nabil, Cairo University
Study Sponsor  ICMJE Cairo University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Cairo University
Verification Date September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP