Effect of Different Biomimetic Materials on White Spot Lesions in Enamel

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.

Study Overview

• Status: Completed
• Conditions: White Spot Lesion
• Intervention / Treatment: Other: Time of assessment

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Faculty of dental medicine for girls branch of Alazhar University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 21 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Zinc carbonated hydroxy apatite; Toothpaste to be added on white spot lesions in dental enamel	Other: Time of assessment; Immediate and after one month and after two months
Experimental: Bioactive glass; Toothpaste to be added on white spot lesions in dental enamel	Other: Time of assessment; Immediate and after one month and after two months
Experimental: Poly amido amine; Resinous material to be painted on white spot lesions in dental enamel	Other: Time of assessment; Immediate and after one month and after two months
No Intervention: Control; No material to be added

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Benha University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Actual): September 18, 2021
• Study Completion (Actual): September 20, 2021

Study Registration Dates

• First Submitted: July 28, 2021
• First Submitted That Met QC Criteria: August 6, 2021
• First Posted (Actual): August 11, 2021

Study Record Updates

• Last Update Posted (Actual): October 7, 2021
• Last Update Submitted That Met QC Criteria: October 5, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: OP-P-018-001; OPDEN-107-1-G (Other Identifier: Faculty of dentistry Alazhar University girls branch)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No