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

NCT ID: NCT03391180

Last Updated: 2018-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-28

Study Completion Date

2018-07-31

Brief Summary

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

Detailed Description

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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).

Conditions

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White Spot Lesion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

ICON Remineralization

Intervention Type DRUG

A material used for the Remineralization of white spot lesions.

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.

Group Type ACTIVE_COMPARATOR

CPP-ACPF

Intervention Type DRUG

Casein phosphopeptide-Amorphous calcium phosphate fluoride used for the remineralization of white spot lesions.

Interventions

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ICON Remineralization

A material used for the Remineralization of white spot lesions.

Intervention Type DRUG

CPP-ACPF

Casein phosphopeptide-Amorphous calcium phosphate fluoride used for the remineralization of white spot lesions.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Riyadh Colleges of Dentistry and Pharmacy

OTHER

Sponsor Role lead

Responsible Party

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Omar Alkadhi

Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Omar H AlKadhi

Role: PRINCIPAL_INVESTIGATOR

Riyadh Colleges of Dentistry and Pharmacy

Locations

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Riyadh Colleges of Dentistry and Pharmacy

Riyadh, ArRiyadh, Saudi Arabia

Site Status

Countries

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Saudi Arabia

Central Contacts

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Omar H AlKadhi, BDS, MS

Role: CONTACT

966505154754

Lougin K Brekeit, BDS

Role: CONTACT

966556461314

Other Identifiers

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FGR/2018/45

Identifier Type: -

Identifier Source: org_study_id

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