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The Effect of ICON Treatment on WPL With Patients After Fixed Orthodontic Appliances

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ClinicalTrials.gov Identifier: NCT03391180
Recruitment Status : Not yet recruiting
First Posted : January 5, 2018
Last Update Posted : January 5, 2018
Sponsor:
Information provided by (Responsible Party):
Omar Alkadhi, Riyadh Colleges of Dentistry and Pharmacy

Brief Summary:
The aim of this study is to determine the effect of ICON on White spot lesions compared to CPP-ACPF plus.

Condition or disease Intervention/treatment Phase
White Spot Lesion Drug: ICON Remineralization Drug: CPP-ACPF Not Applicable

Detailed Description:
The participants were categorized to either group (group1) receiving ICON treatment method (Icon, DMG, Germany), or (group 2) who shall be receiving CPP-ACPF treatment method (Tooth Mousse plus).

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of ICON Treatment on WPL With Patients After Fixed Orthodontic Appliances: A Randomized Controlled Trial
Estimated Study Start Date : February 2018
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rashes

Arm Intervention/treatment
Experimental: ICON Remineralization
Firstly, Conditioning of the WSL surface by 15% HCL gel (Icon-Etch, DNG) and subsequent application of the drying solution (Icon-Dry, DMG), Numbers of additional etching intervals have been determined by visual assessment after each of the etch/dry intervals to achieve individual, customized intensities of WSL surface conditioning.
Drug: ICON Remineralization
A material used for the Remineralization of white spot lesions.

Active Comparator: CPP-ACPF
Participants in group 2 (CPP-ACPF) were treated with applying a pea sized amount of ACC-ACPF plus on a gloved finger of the examiner and rubbed the surface of the labial tooth for 4 minutes with advising the patient to avoid drinking and eating for the next 30 minutes of application.
Drug: CPP-ACPF
Casein phosphopeptide-Amorphous calcium phosphate fluoride used for the remineralization of white spot lesions.




Primary Outcome Measures :
  1. Remineralization [ Time Frame: 3 Months ]
    Using DIAGNOdent Laser device.



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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • permanent dentition, in good general health and without systemic diseases, who had received fixed orthodontic treatment.

Exclusion Criteria:

  • Patients with primary dentition, enamel hypoplasia, dental fluorosis or tetracycline pigmentation and carious cavity were excluded.

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): NCT03391180


Contacts
Contact: Omar H AlKadhi, BDS, MS 966505154754 omar.alkadhi@riyadh.edu.sa
Contact: Lougin K Brekeit, BDS 966556461314 lougin.bk@gmail.com

Locations
Saudi Arabia
Riyadh Colleges of Dentistry and Pharmacy
Riyadh, ArRiyadh, Saudi Arabia, 11681
Sponsors and Collaborators
Riyadh Colleges of Dentistry and Pharmacy
Investigators
Principal Investigator: Omar H AlKadhi Riyadh Colleges of Dentistry and Pharmacy

Responsible Party: Omar Alkadhi, Lecturer, Riyadh Colleges of Dentistry and Pharmacy
ClinicalTrials.gov Identifier: NCT03391180     History of Changes
Other Study ID Numbers: FGR/2018/45
First Posted: January 5, 2018    Key Record Dates
Last Update Posted: January 5, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases