NCT03391180

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 26, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 5, 2018

Completed
27 days until next milestone

Study Start

First participant enrolled

February 1, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

January 5, 2018

Status Verified

January 1, 2018

Enrollment Period

2 months

First QC Date

December 26, 2017

Last Update Submit

January 4, 2018

Conditions

White Spot Lesion

Outcome Measures

Primary Outcomes (1)

  • Remineralization

    Using DIAGNOdent Laser device.

    3 Months

Study Arms (2)

ICON Remineralization

EXPERIMENTAL

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

CPP-ACPF

ACTIVE COMPARATOR

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

Interventions

ICON RemineralizationDRUG

A material used for the Remineralization of white spot lesions.

ICON Remineralization
CPP-ACPFDRUG

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

CPP-ACPF

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riyadh Colleges of Dentistry and Pharmacy

Riyadh, ArRiyadh, 11681, Saudi Arabia

Location

Study Officials

  • Omar H AlKadhi

    Riyadh Colleges of Dentistry and Pharmacy

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Omar H AlKadhi, BDS, MS

CONTACT

966505154754omar.alkadhi@riyadh.edu.sa

Lougin K Brekeit, BDS

CONTACT

966556461314lougin.bk@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

December 26, 2017

First Posted

January 5, 2018

Study Start

February 1, 2018

Primary Completion

April 1, 2018

Study Completion

July 1, 2018

Last Updated

January 5, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

SA(1)