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

The Effect of ICON Treatment on WPL With Patients After Fixed Orthodontic Appliances: A Randomized Controlled Trial

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

Study Overview

• Status: Unknown
• Conditions: White Spot Lesion
• Intervention / Treatment: Drug: ICON Remineralization; Drug: CPP-ACPF

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
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lougin K Brekeit, BDS; Phone Number: 966556461314; Email: lougin.bk@gmail.com

Study Locations

• Saudi Arabia
  • ArRiyadh
    • Riyadh, ArRiyadh, Saudi Arabia, 11681
      • Riyadh Colleges of Dentistry and Pharmacy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Remineralization	Using DIAGNOdent Laser device.	3 Months

Collaborators and Investigators

• Sponsor: Riyadh Colleges of Dentistry and Pharmacy
• Investigators: Principal Investigator: Omar H AlKadhi, Riyadh Colleges of Dentistry and Pharmacy

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2018
• Primary Completion (Anticipated): April 1, 2018
• Study Completion (Anticipated): July 1, 2018

Study Registration Dates

• First Submitted: December 26, 2017
• First Submitted That Met QC Criteria: January 4, 2018
• First Posted (Actual): January 5, 2018

Study Record Updates

• Last Update Posted (Actual): January 5, 2018
• Last Update Submitted That Met QC Criteria: January 4, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: FGR/2018/45

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No