NCT03973554

Brief Summary

to evaluate the caries prevention potential of pearl powder against CPP-ACP in enamel white spot lesions.

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
58

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2019

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

June 1, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 4, 2019

Completed
5 months until next milestone

Study Start

First participant enrolled

October 30, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2021

Completed
Last Updated

June 7, 2019

Status Verified

June 1, 2019

Enrollment Period

1 year

First QC Date

June 1, 2019

Last Update Submit

June 5, 2019

Conditions

White Spot Lesion of Tooth

Keywords

white spot lesions,pearl powderCPP-ACP

Outcome Measures

Primary Outcomes (1)

  • caries prevention in enamel white spot lesion

    caries prevention using laser fluorescence device

    12 months

Study Arms (2)

pearl powder

EXPERIMENTAL

natural product, support bone and joint health

Other: pearl powder

CPP-ACP

ACTIVE COMPARATOR

product for professional use containing the active ingredient (CPP-ACP), a special milk-derived protein that has a unique ability to release bio-available calcium and phosphate to tooth surfaces.

Drug: CPP-ACP

Interventions

pearl powderOTHER

natural product, support bone and joint health

pearl powder
CPP-ACPDRUG

Remineralising sugar free dental topical crème, containing bio-available calcium and phosphate

Also known as: tooth mousse
CPP-ACP

Eligibility Criteria

Age12 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • good oral hygiene
  • cooperative patient
  • completion of orthodontic therapy
  • presence of at least two white spot lesions on the labial surface of six maxillary anterior teeth, that were not present before orthodontic treatment

You may not qualify if:

  • bad oral hygiene
  • lack of patients compliance
  • allergy to milk products
  • pregnant or lactating women
  • presence of dentin caries, restorations, or enamel hypoplasia on maxillary anterior teeth
  • presence of periodontal pockets around maxillary anterior teeth

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

pearl powdercasein phosphopeptide-amorphous calcium phosphate nanocomplex

Study Officials

  • Ruba A El Damarisy, MDS

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ruba A El Damarisy, MDS

CONTACT

01222308685eldamarisyruba@gmail.com

omar shaalan, lecturer

CONTACT

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

June 1, 2019

First Posted

June 4, 2019

Study Start

October 30, 2019

Primary Completion

October 30, 2020

Study Completion

October 30, 2021

Last Updated

June 7, 2019

Record last verified: 2019-06