NCT03187548

Brief Summary

This study is aiming in preventing the formation of WSL associated with orthodontic treatment which occurs to more than 50% of orthodontically treated patients through applying CPP-ACP on the enamel surface once every 2 weeks for 3 months.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jul 2017

Shorter than P25 for phase_1

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 13, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 15, 2017

Completed
16 days until next milestone

Study Start

First participant enrolled

July 1, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

June 15, 2017

Status Verified

June 1, 2017

Enrollment Period

2 months

First QC Date

June 13, 2017

Last Update Submit

June 13, 2017

Conditions

White Spot LesionEnamel Hypomineralization

Keywords

WSLCPP-ACP

Outcome Measures

Primary Outcomes (2)

  • Effect on enamel surface color

    Assessment of the effect of CPP-ACP on enamel surface using ICDAS-II

    3 months

  • Effect on enamel surface

    Assessment of the effect of CPP-ACP on enamel surface using visual analogue scale through digital photograph

    3 mnths

Secondary Outcomes (2)

  • Surface texture

    3 months

  • Microhardnes

    3 months

Study Arms (1)

CPP-ACP

EXPERIMENTAL

Casein phosphopeptide amorphous calcium phosphate dental paste

Drug: Casein Phosphopeptide-Amorphous Calcium Phosphate Dental Paste

Interventions

Casein Phosphopeptide-Amorphous Calcium Phosphate Dental PasteDRUG

Application of CPP-ACP on one premolar once every 2 weeks for 3 months.

CPP-ACP

Eligibility Criteria

Age15 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • severe crowding
  • Increased overjet
  • Protruded maxillary base
  • Sound maxillary premolars
  • medically free
  • molar classification class II
  • Canine classification class II

You may not qualify if:

  • spacing of teeth
  • Decreased overjet
  • Molar classification III Medically compromised patients
  • pregnant females
  • carious premolars
  • hypoplasia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dental Enamel Hypomineralization

Condition Hierarchy (Ancestors)

Developmental Defects of EnamelTooth AbnormalitiesStomatognathic System AbnormalitiesStomatognathic DiseasesTooth DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Maha Swelam, Bachelor

    Department of orthodontics

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fatma Abdou, Professor

CONTACT

01006739365Fatmaabdou@yahoo.com

Mai Abo El Fotouh, Bachelor

CONTACT

01006273998Maha.swelam@gmail.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

June 13, 2017

First Posted

June 15, 2017

Study Start

July 1, 2017

Primary Completion

September 1, 2017

Study Completion

January 1, 2018

Last Updated

June 15, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share