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

NCT06834464 | Completed DMC

• 1 other identifier: 0343
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

White Spot Lesions

Keywords

white spot lesions; diagnodent; remineralization; nanohydroxyapatite

Outcome Measures

Primary Outcomes (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.

  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 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

Study Arms (4)

No treatment group

NO INTERVENTION

No treatment was applied (negative control)

Nano hydroxyapatite paste group

EXPERIMENTAL

Nano hydroxyapatite paste was applied for 5 minutes

Drug: Nanohydroxyapatite paste

HCl + Nano hydroxyapatite paste

EXPERIMENTAL

Pretreatment with 2% HCL for 20 sec then nano hydroxyapatite paste was applied for 5 minutes.

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.

Drug: Nanohydroxyapatite paste; Drug: microabrasion

Interventions

Nanohydroxyapatite paste DRUG

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

Also known as: remineralizing paste

HCl + Nano hydroxyapatite paste; Nano hydroxyapatite paste group; microabrasion + Nano hydroxyapatite paste

HCl liquid DRUG

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

Also known as: hydrochloric acid

HCl + Nano hydroxyapatite paste

microabrasion DRUG

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

Also known as: opalasture

microabrasion + Nano hydroxyapatite paste

Eligibility Criteria

• Age: 10 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• National Research Centre, Egypt: lead

Study Sites (1)

the National research Centre

Dokki, Giza Governorate, 12622, Egypt

Location

Related Publications (3)

• 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.

  PMID: 21525682 BACKGROUND

• 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.

  PMID: 27695330 BACKGROUND

• 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. doi: 10.1186/s12903-025-07365-5. Online ahead of print.

  PMID: 41530802 DERIVED

MeSH Terms

Interventions

Hydrochloric Acid; Enamel Microabrasion

Intervention Hierarchy (Ancestors)

Acids, Noncarboxylic; Acids; Inorganic Chemicals; Chlorine Compounds; Esthetics, Dental; Dentistry

Study Officials

• Maryam m El Mansy, researcher

  The National Research Centre, Egypt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Blinding was done to the outcomes assessor and the child and care provider. the outcome assessor has assessed the outcome of each treatment without knowing the type of treatment done. the child was blinded as he was not aware of the type of treatment applied to him. The care provider was blind and he was not allowed to accompany the child during treatment application
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher of Pediatric Dentistry, Orthodontics and Pediatric Dentistry Department, Oral and Dental Research Institute

Model Details: randomized controlled parallel double blinded study

Study Record Dates

• First Submitted: February 13, 2025
• First Posted: February 19, 2025
• Study Start: December 5, 2024
• Primary Completion: January 20, 2025
• Study Completion: January 30, 2025
• Last Updated: February 24, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)