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Comparing Three Remineralizing Gels for Treating White Spot Marks After Braces in Children Using a Custom Essix Tray.

Comparative Evaluation of Casein Phosphopeptide-Amorphous Calcium Phosphate Gel, Calcium Sucrose Phosphate Gel and a Novel Herbal-Nano Hydroxyapatite Gel in the Management of Post Orthodontic White Spot Lesions in Children by Using a Modified Essix Appliance a Randomized Controlled Trial - NIL

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/04/109395
Enrollment
80
Registered
2026-04-27
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Casein Phosphopeptide Amorphous Calcium Phosphate Tooth Mousse (Modified Essix Appliance with Reservoirs): Casein phosphopeptide amorphous calcium phosphate is a well-established remine

Sponsors

Ankita Shintre
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1 Patients with post orthodontic white spot lesions who had started orthodontic or myofunctional appliance therapy at or below 13 years of age. 2 Presence of more than or equal to 2 noncavitated WSLs (White Spot Lesions) on maxillary anterior teeth, visible with or without air drying after debonding (ICDAS II score 1 or 2). 3 Good general health. 4 Parent/Guardian willing to give written informed consent.

Exclusion criteria

Exclusion criteria: 1 Allergy to one of the components of the product. 2 Cavitated lesions (ICDAS more than or equal to 3). 3 Fluorosis, MIH, or enamel hypoplasia. 4 Dentin caries or restorations on index teeth. 5 Patients who have received professional fluoride therapy within the previous three months will be excluded from the study.

Design outcomes

Primary

MeasureTime frame
Primary outcome Reduction in white spot lesion area measured using ImageJ analysis at baseline 4 weeks 8 weeks and 12 weeksTimepoint: 2 years 2 months

Secondary

MeasureTime frame
Change in ICDAS II scores over time Inter group comparison of remineralizing agents Intra group comparison of lesion improvement at different time intervalsTimepoint: 2 years, 2 months

Countries

India

Contacts

Public ContactAnkita Shintre

MIDSR, Dental College, Latur

ankitashintre131@gmail.com9146599839

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026