Clinical trial NCT06821724: Effect of Different Remineralizing Agents on White Spot Lesions Treatment in Children
Official title: Comparative Study on the Effect of Different Remineralizing Agents Versus Fluoride Gel on White Spot Lesions After In-Office Followed by Home Treatment in Children: A Randomized Controlled Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: White Spot Lesion of Tooth
Keywords: White spots
Remineralization
Caries
Children
Lead sponsor: National Research Centre, Egypt
Sponsor class: OTHER
First posted: 2025-02-12
Enrollment: 100
Sex: ALL
Minimum age (years): 10
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Randomized controlled parallel double blinded study
Primary purpose: TREATMENT

Brief summary: One hundred children with white spot lesions on their teeth were divivided into 5 groups of different remineralizing agents to assess their effect on color change and remineralization

Detailed description: Children having at least one tooth clinically diagnosed by white spot lesion were randomly allocated to five groups.

Group one: No treatment was applied (negative control). Group two: Fluoride gel was applied for 5 minutes (positive control). Group three: Casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) (MI paste) was applied for 5 minutes.

Group four: Casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) + fluoride (MI paste plus) were applied for 5 minutes.

Group five: Nano hydroxyapatite paste (Apagard primo toothpaste) was be applied for 5 minutes.

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

Each agent was applied to the labial surfaces of each tooth affected with white spot lesion for 5 minutes after cleaning and drying with a cotton roll using an applicator tip. After each application, children were instructed not to eat or drink for one hour. This application was be repeated in-office after one then after two weeks then after six weeks.

Participants received a sterilized pouch containing a sterile container with one of the pastes according to the study group for home application. The application of the paste was carried out under parental supervision and was asked to apply each of the pastes at home three times a day till the end of the study

Eligibility criteria: Inclusion Criteria:

1. Presence of at least one tooth affected by white spot lesion.
2. Good oral hygiene and regular tooth brushing at least twice daily.

Exclusion Criteria:

1. Unwillingness to be randomly assigned to 1 of the 3 treatment groups.
2. Presence of abnormal oral, medical, or mental condition.
3. Presence of any milk-related allergies.
4. Presence of dentin caries or enamel hypoplasia on maxillary anterior teeth.
5. Presence of periodontal pockets around maxillary anterior teeth.

Primary outcomes:
measure: Assessment of color change
timeFrame: before treatment, immediately after treatment, 2 weeks and 6 weeks after the onset of treatment
Secondary outcomes:
measure: Remineralization assessment
timeFrame: before treatment, immediately after treatment, 2 weeks and 6 weeks after the onset of treatment
Other outcomes:
Locations:
city: Dokki
country: Egypt
facility: National Research Centre
state: Giza
Study officials:
affiliation: National Research Centre, Egypt
name: Mohamed F Rashed, Researcher
role: STUDY_DIRECTOR
References: