NCT03963791

Brief Summary

This research is conducted to compare the remineralization efficacy of eggshell powder gel and CPP-ACP (MI paste) on post-orthodontic white spot lesions.

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
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2019

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

May 15, 2019

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 28, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

October 5, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 5, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

May 28, 2019

Status Verified

May 1, 2019

Enrollment Period

6 months

First QC Date

May 15, 2019

Last Update Submit

May 22, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • white spot lesion progression.

    The change in the lesion fluorescence will be evaluated using diode laser fluorescence device (Diagnodent).

    6 months.

Study Arms (2)

Eggshell powder gel

EXPERIMENTAL

prepared from eggshell powder. applied on the tooth surfaces twice daily (after breakfast and before bedtime) after brushing the teeth.

Other: Eggshell powder gelOther: CPP-ACP crème

CPP-ACP crème

ACTIVE COMPARATOR

CPP-ACP crème (GC Tooth Mousse). applied on the tooth surfaces twice daily (after breakfast and before bedtime) after brushing the teeth.

Other: Eggshell powder gelOther: CPP-ACP crème

Interventions

Eggshell powder gel produced from chicken eggs.

Also known as: Natural product
CPP-ACP crèmeEggshell powder gel

A water-based, sugar-free topical cream containing Recaladent (CCP-ACP) which is derived from the milk protein.

Also known as: MI Paste
CPP-ACP crèmeEggshell powder gel

Eligibility Criteria

Age13 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • A patient who has just completed a comprehensive orthodontic treatment.
  • Presence of at least one WSL, DIAGNOdent score (0-20).
  • Age range between 13 and 35years.

You may not qualify if:

  • Patients are unable to return for recall appointments.
  • High caries risk.
  • Have plaque accumulation and a periodontal problem
  • In progress treatment of chronic disease.
  • Presence of abnormal oral, medical, or mental condition (including any milk-related allergies or any medical condition involving kidneys or salivary glands).
  • Presence of dentin caries, enamel hypoplasia or restorations on maxillary anterior teeth.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo univercity

Cairo, 002, Egypt

Location

MeSH Terms

Conditions

Dental Caries

Interventions

Biological Products

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Complex Mixtures

Study Design

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

Study Record Dates

First Submitted

May 15, 2019

First Posted

May 28, 2019

Study Start

October 5, 2019

Primary Completion

April 5, 2020

Study Completion

June 1, 2020

Last Updated

May 28, 2019

Record last verified: 2019-05

Locations