Effect of Different Remineralizing Agents on White Spot Lesions Treatment in Children (RCT)

National Research Centre, Egypt

Status: Completed

Conditions: White Spot Lesion of Tooth

Treatments: Drug: Casein phosphopeptide-amorphous calcium phosphate + fluoride; Drug: Casein phosphopeptide-amorphous calcium phosphate; Drug: Nano hydroxyapatite paste; Drug: Fluoride gel

Study type: Interventional

Funder types: Other

Identifiers

NCT06821724

342

Details and patient eligibility

About

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

Full 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

Enrollment: 100 patients

Sex: All

Ages: 10 to 14 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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100 participants in 5 patient groups

No treatment

No Intervention group

Description:

Negative control

Fluoride gel

Active Comparator group

Description:

Positive control

Treatment:

Drug: Fluoride gel

Casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) (MI paste)

Experimental group

Description:

Intervention

Treatment:

Drug: Casein phosphopeptide-amorphous calcium phosphate

Casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) + fluoride (MI paste plus)

Experimental group

Description:

Intervention

Treatment:

Drug: Casein phosphopeptide-amorphous calcium phosphate + fluoride

Nano hydroxyapatite paste (Apagard primo toothpaste)

Experimental group

Description:

Intervention

Treatment:

Drug: Nano hydroxyapatite paste