Effect of Nanohydroxyapatite Paste After Different Pretreatment Techniques on White Spot White Spot Lesions

February 20, 2025 updated by: Maryam Mohamed Ibrahim El Mansy, National Research Centre, Egypt

Effect of Nanohydroxyapatite Paste After Different Pretreatment Techniques on Remineralization and Color Change of White Spot Lesions In Children: A Randomized Control Study.

forty teeth diagnosed with white spot lesions in children aged between 10-14 years old were selected to compare between the effect of using nanohydroxyapatite paste applicatio either alone or preceded by the application of HCl (hydrochloric acid) or microabrasion

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study was designed as a randomized controlled double blinded clinical trial in which forty teeth clinically diagnosed with white spot lesions collected from children of both sexes with age range between 10-14 years old was selected from the outpatient clinics of the National Research Centre.

Ethical approval was obtained from the Medical Research Ethics Committee, National Research Centre with number 0343 Written informed consent was taken from the legal guardian of each participating child willing to participate in the trial, prior to the start of the clinical procedure after explaining the whole procedure in a simple way. The consent form was written in Arabic. verbal approval was taken from the child . Parallel allocation design was adopted for the intervention and control arms with allocation ration 1: 1 (i.e. 10 cases each).

The sample size was calculated considering the previously published studies with 80% power in detecting the true statistical significance among the four groups.

The inclusion criteria dictated that the patients should be in the age range of 10 to 14 years, presenting at least 1 White spot lesion on the labial surface of one or more permanent upper or lower anterior teeth.

The exclusion criteria involved patients who had hypoplastic enamel and those with dentine caries, patients who had systemic diseases and also uncooperative patients.

. All children involved in this study was instructed to brush their teeth under the supervision of the researcher before the application of the studied agent.

The buccal surfaces of the study-group teeth was cleaned with water slurry of pumice and rubber prophy cups. After cleaning and drying with a cotton roll, the application of the agent was done for 5 minutes using an applicator tip. After each application, children was instructed not to eat or drink for 1 hour

The same process was repeated in three separated visits in periods of one week, two weeks and six weeks on teeth in each of study and control group.

Grouping of samples:

Group 1: No treatment was applied (negative control). Group 2: Nano hydroxyapatite paste (Apagard primo toothpaste) was applied for 5 minutes.

Group 3: Pretreatment with 2% HCL for 20 sec then nano hydroxyapatite paste (Apagard primo toothpaste) was applied for 5 minutes.

Group 4: Pretreatment with microabrasion with oplasture for 60 sec then nano hydroxyapatite paste (Apagard primo toothpaste) was applied for 5 minutes.

Assessment:

A) Assessment of color change:

Color change of white spot lesions was assessed; before treatment, immediately after treatment, 2 weeks and 6 weeks after the onset of treatment on each tooth in each of study groups and control group using Vita easy shade device.

Prior each measurement, the device was calibrated according to the manufacturer's instructions.

B) Remineralization assessment:

Remineralization assessment was done using Laser fluorescence device "DIAGNOdent® (KaVo)".

All the teeth of the patients included in the study was examined using DIAGNOdent® (KaVo) as recommended by the manufacturer to assess the remineralization process.

All the measurements was performed using the Type B tip, which are designed for flat surfaces like the buccal one. Prior to each measurement, the device was calibrated using a ceramic standard according to the manufacturer's instructions.

The mineralization of the lesion was measured using DIAGNOdent laser fluorescence device before the application and another reading was recorded after 10 min of application. Other recordings was taken at one week, two weeks and six weeks on teeth in each of study and control group

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Giza
      • Dokki, Giza, Egypt, 12622
        • the National research Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion criteria:

  • age range of children is 10 to 14 years
  • presence of at least 1 White spot lesion on the labial surface of one or more permanent upper or lower anterior teeth.

Exclusion criteria:

  • hypoplastic enamel
  • dentine caries,
  • patients with systemic diseases
  • uncooperative patient

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: No treatment group
No treatment was applied (negative control)
Experimental: Nano hydroxyapatite paste group
Nano hydroxyapatite paste was applied for 5 minutes
Drug: Nanohydroxyapatite paste
nanohydroxyapatite paste will be applied with a brush on the surface of the teeth
Other Names:
  • remineralizing paste
Experimental: HCl + Nano hydroxyapatite paste
Pretreatment with 2% HCL for 20 sec then nano hydroxyapatite paste was applied for 5 minutes.
Drug: Nanohydroxyapatite paste
nanohydroxyapatite paste will be applied with a brush on the surface of the teeth
Other Names:
  • remineralizing paste
Drug: HCl liquid
HCl liquid will be applied for 60 seconds prior to application of nanohydroxyapatite paste in certain groups
Other Names:
  • hydrochloric acid
Experimental: microabrasion + Nano hydroxyapatite paste
Pretreatment with microabrasion with oplasture for 60 sec then nano hydroxyapatite paste was applied for 5 minutes.
Drug: Nanohydroxyapatite paste
nanohydroxyapatite paste will be applied with a brush on the surface of the teeth
Other Names:
  • remineralizing paste
Drug: microabrasion
the material will be applied on the surface of teeth then microabrasion will be done with a rubber cup for 60 seconds
Other Names:
  • opalasture

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of color change
Time Frame: Color change of white spot lesions was assessed; before treatment, immediately after treatment, 2 weeks and 6 weeks after the onset of treatment on each tooth in each of study groups
Color change of white spot lesions was assessed; the onset of treatment on each tooth in each of study groups and control group using Vita easy shade device.
Color change of white spot lesions was assessed; before treatment, immediately after treatment, 2 weeks and 6 weeks after the onset of treatment on each tooth in each of study groups

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Remineralization assessment All the teeth of the patients included in the study will be examined using DIAGNOdent® (KaVo) as recommended by the manufacturer to assess the remineralization process.
Time Frame: Remineralization of white spot lesions was assessed; before treatment, immediately after treatment, 2 weeks and 6 weeks after the onset of treatment on each tooth in each of study groups
Remineralization assessment was done using Laser fluorescence device "DIAGNOdent
Remineralization of white spot lesions was assessed; before treatment, immediately after treatment, 2 weeks and 6 weeks after the onset of treatment on each tooth in each of study groups

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Research Centre, Egypt

Investigators

  • Principal Investigator: Maryam m El Mansy, researcher, The National Research Centre, Egypt

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 5, 2024

Primary Completion (Actual)

January 20, 2025

Study Completion (Actual)

January 30, 2025

Study Registration Dates

First Submitted

February 13, 2025

First Submitted That Met QC Criteria

February 13, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 20, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0343

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

no plan to share

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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