NCT05001035

Brief Summary

This study will be conducted to evaluate: 1- The remineralizing effect of different biomimetic materials (Zinc carbonate hydroxyapatite nanoparticles, Poly-amido amine (PAMAM) and bioactive glass nanoparticles) on white spot lesions in enamel. 2- The clinical efficacy of these agents on disappearance of these white spots.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

July 1, 2021

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

July 28, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 11, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 18, 2021

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2021

Completed
Last Updated

October 7, 2021

Status Verified

October 1, 2021

Enrollment Period

3 months

First QC Date

July 28, 2021

Last Update Submit

October 5, 2021

Conditions

White Spot Lesion

Outcome Measures

Primary Outcomes (2)

  • change in remineralization from base line to time limit

    Change in its density in digital xray

    Immediate and one month and two months

  • changes of appearance from base line photograph to time limit

    White spots disappear on digital photography

    Immediate and one month and two months

Study Arms (4)

Zinc carbonated hydroxy apatite

EXPERIMENTAL

Toothpaste to be added on white spot lesions in dental enamel

Other: Time of assessment

Bioactive glass

EXPERIMENTAL

Toothpaste to be added on white spot lesions in dental enamel

Other: Time of assessment

Poly amido amine

EXPERIMENTAL

Resinous material to be painted on white spot lesions in dental enamel

Other: Time of assessment

Control

NO INTERVENTION

No material to be added

Interventions

Time of assessmentOTHER

Immediate and after one month and after two months

Bioactive glassPoly amido amineZinc carbonated hydroxy apatite

Eligibility Criteria

Age15 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Total of 21 patients enrolled in this study will be selected having at least 4 teeth (one on each quadrant) which will be extracted for orthodontic treatment.
  • These patients will be selected according to age groups between 15-25 years old
  • good oral hygiene
  • free of destroying habits for dental tissues

You may not qualify if:

  • Bruxism
  • soft drinks consumption
  • acid regurgitation, etc.).
  • Selected teeth having any cracks, malformations, dysplasia or caries.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of dental medicine for girls branch of Alazhar University

Cairo, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Split mouth technique
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dental specialist at benha teaching hospital

Study Record Dates

First Submitted

July 28, 2021

First Posted

August 11, 2021

Study Start

July 1, 2021

Primary Completion

September 18, 2021

Study Completion

September 20, 2021

Last Updated

October 7, 2021

Record last verified: 2021-10

Locations

EG(1)