Clinical trial NCT06834464: Effect of Nanohydroxyapatite Paste After Different Pretreatment Techniques on White Spot White Spot Lesions
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: White Spot Lesions
Keywords: white spot lesions
diagnodent
remineralization
nanohydroxyapatite
Lead sponsor: National Research Centre, Egypt
Sponsor class: OTHER
First posted: 2025-02-19
Enrollment: 40
Sex: ALL
Minimum age (years): 10
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled parallel double blinded study
Primary purpose: TREATMENT

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

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

Eligibility criteria: 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

Primary outcomes:
measure: Assessment of color change
timeFrame: 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:
measure: 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.
timeFrame: 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
Other outcomes:
Locations:
city: Dokki
country: Egypt
facility: the National research Centre
state: Giza
Study officials:
affiliation: The National Research Centre, Egypt
name: Maryam m El Mansy, researcher
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.