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White Spot LesionsNCT06834464

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

A study testing Nanohydroxyapatite paste, HCl liquid and microabrasion in people with White Spot Lesions, run by National Research Centre, Egypt at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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 Read more about this study

Who is it for?
Ages 10 to 14 yearsHealthy volunteers can take part
Conditions the study is for
White Spot Lesions
What is being tested?
Nanohydroxyapatite paste, HCl liquid and microabrasion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteEgypt
Study dates
5 Dec 2024to 30 Jan 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 to 14 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • the National research Centre

    Dokki, Giza Governorate, 12622

Other trials in Egypt

About this study

Official title: 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

Read the 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:

  1. 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.

  1. 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

Being tested
Nanohydroxyapatite paste, HCl liquid, microabrasion
Keywords
white spot lesions, diagnodent, remineralization, nanohydroxyapatite

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nanohydroxyapatite pasteDrug

    Also called remineralizing paste

    nanohydroxyapatite paste will be applied with a brush on the surface of the teeth

  • HCl liquidDrug

    Also called hydrochloric acid

    HCl liquid will be applied for 60 seconds prior to application of nanohydroxyapatite paste in certain groups

  • microabrasionDrug

    Also called opalasture

    the material will be applied on the surface of teeth then microabrasion will be done with a rubber cup for 60 seconds

Study groups in NCT06834464
Study groupRoleWhat they receive
No treatment groupNo interventionNo treatment was applied (negative control)
Nano hydroxyapatite paste groupExperimentalNano hydroxyapatite paste was applied for 5 minutes
Receives: Drug: Nanohydroxyapatite paste
HCl + Nano hydroxyapatite pasteExperimentalPretreatment with 2% HCL for 20 sec then nano hydroxyapatite paste was applied for 5 minutes.
Receives: Drug: Nanohydroxyapatite paste; Drug: HCl liquid
microabrasion + Nano hydroxyapatite pasteExperimentalPretreatment with microabrasion with oplasture for 60 sec then nano hydroxyapatite paste was applied for 5 minutes.
Receives: Drug: Nanohydroxyapatite paste; Drug: microabrasion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Assessment of color change

    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.

    Measured: 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 outcomes (1)
  1. 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.

    Remineralization assessment was done using Laser fluorescence device "DIAGNOdent

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Feb 2025
  2. Study start5 Dec 2024
  3. Primary completion20 Jan 2025
  4. Study completion30 Jan 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
randomized controlled parallel double blinded study
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06834464
Sponsor's protocol ID
0343
Status last verified
Feb 2025
First submitted
13 Feb 2025
Last updated
24 Feb 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: no plan to share

Publications

  • Jayarajan J, Janardhanam P, Jayakumar P; Deepika. Efficacy of CPP-ACP and CPP-ACPF on enamel remineralization - an in vitro study using scanning electron microscope and DIAGNOdent. Indian J Dent Res. 2011 Jan-Feb;22(1):77-82. doi: 10.4103/0970-9290.80001.

    PubMed 21525682
  • Abou Neel EA, Aljabo A, Strange A, Ibrahim S, Coathup M, Young AM, Bozec L, Mudera V. Demineralization-remineralization dynamics in teeth and bone. Int J Nanomedicine. 2016 Sep 19;11:4743-4763. doi: 10.2147/IJN.S107624. eCollection 2016.

    PubMed 27695330
  • El Mansy MM, Saleh RS, Rashed MF, El-Motayam AK. Effect of nanohydroxyapatite paste after different pretreatment techniques on remineralization and color change of white spot lesions in children: a randomized control study. BMC Oral Health. 2026 Jan 13;26(1):102. doi: 10.1186/s12903-025-07365-5.

    PubMed 41530802

Questions about this trial

What is this clinical trial studying?

A study testing Nanohydroxyapatite paste, HCl liquid and microabrasion in people with White Spot Lesions, run by National Research Centre, Egypt at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06834464, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2025.

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