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.
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.
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:
- 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.
- 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
- Conditions
- White Spot Lesions
- 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 group | Role | What they receive |
|---|---|---|
| No treatment group | No intervention | No treatment was applied (negative control) |
| Nano hydroxyapatite paste group | Experimental | Nano hydroxyapatite paste was applied for 5 minutes Receives: Drug: Nanohydroxyapatite paste |
| HCl + Nano hydroxyapatite paste | Experimental | Pretreatment 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 paste | Experimental | Pretreatment 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.
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)
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.
- First posted19 Feb 2025
- Study start5 Dec 2024
- Primary completion20 Jan 2025
- Study completion30 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for White Spot LesionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- National Research Centre, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maryam Mohamed Ibrahim El Mansy, National Research Centre, Egypt
- Investigators
- Maryam m El Mansy, researcher, Principal investigator, The National Research Centre, Egypt
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 21525682Abou 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 27695330El 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
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06834464
- Acronym / sponsor ID
- 0343
- Conditions
- White Spot Lesions
- Keywords
- white spot lesions, diagnodent, remineralization, nanohydroxyapatite
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- National Research Centre, EgyptUniversity, hospital or other
- Study start
- 5 Dec 2024 (actual)
- Primary completion
- 20 Jan 2025 (actual)
- Study completion
- 30 Jan 2025 (actual)
- First posted
- 19 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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:
- 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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
- Model description
- randomized controlled parallel double blinded study
| Arm | Type | Receives |
|---|---|---|
| No treatment group | No intervention | –No treatment was applied (negative control) |
| Nano hydroxyapatite paste group | Experimental | Drug: Nanohydroxyapatite pasteNano hydroxyapatite paste was applied for 5 minutes |
| HCl + Nano hydroxyapatite paste | Experimental | Drug: Nanohydroxyapatite paste, Drug: HCl liquidPretreatment with 2% HCL for 20 sec then nano hydroxyapatite paste was applied for 5 minutes. |
| microabrasion + Nano hydroxyapatite paste | Experimental | Drug: Nanohydroxyapatite paste, Drug: microabrasionPretreatment with microabrasion with oplasture for 60 sec then nano hydroxyapatite paste was applied for 5 minutes. |
Who may qualify
- Ages
- 10 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- hypoplastic enamel
- dentine caries,
- patients with systemic diseases
- uncooperative patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nanohydroxyapatite pasteAlso: remineralizing pastenanohydroxyapatite paste will be applied with a brush on the surface of the teeth | Drug | HCl + Nano hydroxyapatite paste, Nano hydroxyapatite paste group, microabrasion + Nano hydroxyapatite paste |
| HCl liquidAlso: hydrochloric acidHCl liquid will be applied for 60 seconds prior to application of nanohydroxyapatite paste in certain groups | Drug | HCl + Nano hydroxyapatite paste |
| microabrasionAlso: opalasturethe material will be applied on the surface of teeth then microabrasion will be done with a rubber cup for 60 seconds | Drug | microabrasion + Nano hydroxyapatite paste |
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
- Background: PubMed 21525682Jayarajan 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.
- Background: PubMed 27695330Abou 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.
- Derived from this study: PubMed 41530802El 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.
- Individual participant dataSharing planned: No. no plan to share
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maryam m El Mansy, researcher principal investigator
The National Research Centre, Egypt
1 site in 1 country: see every site and its status.
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.