Remineralization Potential of MI Varnish Versus Fluoride Varnish on White Spot Lesions in Maxillary Primary Incisors

Remineralization Potential of MI Varnish(CPP-ACP and Fluoride) Versus Fluoride Varnish in Controlling White Spot Lesions in Maxillary Primary Incisors: A Randomized Clinical Trial

Remineralization effect of CPP-ACP and Fluoride (MI varnish) versus Fluoride varnish on white spot lesions in maxillary primary incisors

Study Overview

• Status: Completed
• Conditions: Remineralization Effect of the Varnish on White Spot Lesions
• Intervention / Treatment: Other: MI varnish

Detailed Description

Early childhood caries (ECC) is a very common and consequential chronic disease affecting young children ( Çolak et al., 2013). The prevalence of ECC in Egypt is high, it is about (78%) according to the last Egyptian Report, 2014.

ECC begins with white-spot lesions, and caries can progress continuously, leading to complete destruction of the crown. Calcium and phosphate ions are more readily lost for children because lower mineralization of deciduous enamel. The disease usually develops very quickly and causes many childhood health problems, such as caries-related toothache and infection.

Demineralization and remineralization are dynamic processes in caries initiation, progression, and reversal. Therefore, regulation of the demineralization- remineralization balance is a key to caries prevention and treatment. The ideal method of increasing remineralization is reconstructing the depleted tissues with hydroxyapatite, which is the same inorganic component as the enamel.

Fluoride varnishes have been the standard practice for the professional application of fluoride.

Casien PhosphoPeptide (CPP) is a sticky protein that binds and stabilizes calcium and phosphate ions in an amorphous state. CPP-ACP has been shown to adhere to teeth surfaces.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Faculty of Dentistry- Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 5 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Children with white spot lesions on their incisors.
2. Age ranging 3-5 years.
3. Good general health.

Exclusion Criteria:

1. Chronic use of medications or antibiotics 2. lack of cooperation in the oral examination 3. Allergies to milk protein or benzoate preservatives 4. Presence of oral soft-tissue lesions or enamel hypoplasia at baseline examination, 5. Children who have received a fluoride supplement or professional topical fluoride application at least 3 months before or during the study period.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: MI Varnish	Other: MI varnish; CPP- ACP with 5 % sodium fluoride GC; Other Names: CPP- ACP with fluoride
ACTIVE_COMPARATOR: Profluorid Varnish	Other: MI varnish; CPP- ACP with 5 % sodium fluoride GC; Other Names: CPP- ACP with fluoride

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Caries activity	Measured by ICDAS II	Change from base line, after application at 3, 6, 9 last follow up 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Remineralization	Measured by EDI	Change from base line, after application at 3, 6, 9 last follow up 12 months

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2019
• Primary Completion (ACTUAL): March 1, 2020
• Study Completion (ACTUAL): July 1, 2020

Study Registration Dates

• First Submitted: November 3, 2018
• First Submitted That Met QC Criteria: November 3, 2018
• First Posted (ACTUAL): November 6, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 21, 2020
• Last Update Submitted That Met QC Criteria: July 17, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: fluoride; Early childhood caries; Casein phosphopeptides-amorphous calcium phosphate; remineralization potential; varnish
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Protective Agents; Cariostatic Agents; Fluorides
• Other Study ID Numbers: CEBD-CU-28-10-2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No