Clinical trial NCT06566833: Effectiveness of Different Remineralizing Strategies on the Management of Early Carious Lesions in Primary Teeth
Official title: Effectiveness of Different Remineralizing Strategies on the Management of Early Carious Lesions in Primary Teeth (Randomized Controlled Clinical Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: White Spot Lesion
Keywords: curodont repair fluoride plus
CPP-ACPF
sodium fluoride varnish
guided enamel regeneration
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2024-08-22
Enrollment: 66
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: the primary aim of the study is remineralization of early carious lesions in primary teeth using different remineralizing agents of different remineralizing strategies when applied in an intensive mode. The secondary aim of the study is to compare their antibacterial effect against streptococcus mutans and their effect on reducing the size of the lesions.

Detailed description: The primary aim of the study is to compare the effect of curodont repair fluoride plus (self-assembling peptide p11-4 with 0.5% sodium fluoride) with MI varnish (casein phosphopeptide amorphous calcium phosphate fluoride) and Colgate fluoride varnish (5% sodium fluoride) in remineralization of early carious lesions in primary anterior teeth. The study sample is consisted of 66 patients aged 3-6 years old with at least 2 white spot lesions in their primary anterior teeth who are assigned into control group (n=22): colgate fluoride varnish, test group 1(n=22): MI varnish and test group 2 (n=22) :curodont repair fluoride plus. Each material is applied once every 2 weeks for 3 times (intensive mode of application). The secondary aim of the study is to determine the antibacterial effect of each material against streptococcus mutans is compared by obtaining a plaque sample at baseline then after application by 48 hours, 1 months and 3 months and culturing using disk diffusion method for determining the log count of streptococcus mutans at each time point. Another secondary aim is to determine the change in lesion size at baseline and after 6 months and 12 months using standardized photographs with a digital camera.

Eligibility criteria: Inclusion Criteria:

1. healthy children
2. age range 3-6
3. at least 2 early carious lesions

Exclusion Criteria:

1. Children presenting with special health care needs or undergoing medical treatment for chronic or acute diseases.
2. Application of fluoride varnish less than 3 months prior to study treatment.
3. Any metabolic disorders affecting bone turnover.
4. Concurrent participation in another clinical trial.
5. Patients receiving any antibiotic within 1 month prior to plaque sample collection

Primary outcomes:
measure: Assessing the remineralization of early carious lesions in primary teeth
timeFrame: 3,6,9 and12 months
Secondary outcomes:
measure: comparing the change in esthetic appearance of early carious lesion before and after treatment
timeFrame: 12 months
measure: comparing the antibacterial effect of different remineralizing agents against streptococcus mutans
timeFrame: 3 months
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Karin Dowidar
state: Professor
Study officials:
affiliation: faculty of Dentistry, Alexandria university, Egypt
name: karin dowidar, professor
role: STUDY_DIRECTOR
References:
citation: Mekky AI, Dowidar KML, Talaat DM. Casein Phosphopeptide Amorphous Calcium Phosphate Fluoride Varnish in Remineralization of Early Carious Lesions in Primary Dentition: Randomized Clinical Trial. Pediatr Dent. 2021 Jan 15;43(1):17-23.