Self-assembling Peptide With Sodium Fluoride in Treating White Spot Lesionss in Primary Teeth
Effectiveness of Self-assembling Peptide (p11-4) in Conjunction With Fluoride Varnish in the Management of White Spot Lesions in Primary Teeth (Randomized Controlled Clinical Trial)
1 other identifier
interventional
24
1 country
1
Brief Summary
Regenerative medicine-based approaches for caries treatment focus on biomimetic remineralization of initial carious lesions as a minimally invasive therapy using Self-Assembling Peptide P11-4 (CURODONTTM REPAIR) which enhances remineralization of white spot lesions (WSLs). The study aimed to assess clinically the effect of Self Assembling Peptide P11-4 (CURODONTTM REPAIR) + Fluoride varnish (DURAFLOR) versus a 5% fluoride varnish (DURAFLOR) on remineralization of enamel White Spot Lesions in primary teeth.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2021
CompletedFirst Submitted
Initial submission to the registry
February 1, 2023
CompletedFirst Posted
Study publicly available on registry
February 10, 2023
CompletedFebruary 10, 2023
February 1, 2023
12 months
February 1, 2023
February 1, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Change in DIAGNOdent readings
The measurements with the DIAGNOdent device that provides numerical values from 0 to 99
Baseline, 3 months, and 6 months
Secondary Outcomes (2)
Change in ICDAS II scores
Baseline, 3 months, and 6 months
Change in Nyvad scores
Baseline, 3 months, and 6 months
Study Arms (2)
CURODONTTM REPAIR: + Fluoride varnish (DURAFLOR)
EXPERIMENTALFluoride Varnish (DURAFLOR) only
ACTIVE COMPARATORInterventions
The WSL was Acid etched with phosphoric acid gel 35-37% for 20 seconds, the tooth surface was rinsed with water and then dried afterwards application of CURODONTTM REPAIR
A very thin coat of the DURAFLOR varnish was applied by a thin brush which was then allowed to dry for 10 seconds. The varnish hardens on contact with saliva or moisture
Eligibility Criteria
You may qualify if:
- children with high caries risk with the presence of at least one visible active WSL in primary teeth with ICDAS II score of 1, 2 or 3
You may not qualify if:
- Children with systemic diseases
- Teeth with cavitated lesion involving dentin and enamel defects
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Alexandria Faculty of Dentistry
Alexandria, Egypt
MeSH Terms
Interventions
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant lecturer of DPH and Clinical statistician
Study Record Dates
First Submitted
February 1, 2023
First Posted
February 10, 2023
Study Start
June 1, 2020
Primary Completion
May 30, 2021
Study Completion
May 30, 2021
Last Updated
February 10, 2023
Record last verified: 2023-02