Antimicrobial primer versus Regular primer to prevent early caries in orthodontically treated patients

Phase 3

Completed

• Conditions: Dental caries on smooth surface, (2) ICD-10 Condition: M264||Malocclusion, unspecified,

• Registration Number: CTRI/2023/12/060589
• Lead Sponsor: Dr Ritu Gupta

Brief Summary

Formation of White Spot Lesions is a common unwanted adverse effect of fixed orthodontic therapy. This randomized clinical trial is to assess the ability of an organoselenium-containingprimer to prevent demineralization and formation of White Spot Lesions in comparison to a routinely used primer during orthodontic treatment with fixed appliances around orthodontic brackets, by using visual inspection and photographic images.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-24
• Study Completion: 2024-02-20
• Last Update Posted: 2025-03-20

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Age group 18 years and above.
• Patients with malocclusion in the permanent dentition and requiring fixed orthodontic treatment.
• Good oral hygiene status Full eruption of posterior teeth.

Exclusion Criteria

• Congenitally missing or impacted teeth.
• Teeth extracted due to caries.
• Presence of active carious lesion or enamel hypoplasia Previous history of active orthodontic treatment or extractions Patient with growth and developmental anomaly or general diseases History of any cosmetic allergy Heavy restorations; periodontal diseases, abnormal oral conditions, history of smoking Enamel demineralization or fluorosis staining or bleaching or fluoridation.
• Severe crowding >6 mm or severely rotated teeth (limiting the appearance of buccal surfaces).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduced formation of White Spot Lesions (WSLs) during fixed orthodontic treatment with organoselenium primer	white spot lesions will be assessed every 4 weeks

Secondary Outcome Measures

Name	Time	Method
early detection and prevention of white spot lesions in fixed orthodontic treatment	one year

Trial Locations

Locations (1)

Indira Gandhi Institute of Dental Sciences; 🇮🇳 Pondicherry, PONDICHERRY, India

Indira Gandhi Institute of Dental Sciences

🇮🇳Pondicherry, PONDICHERRY, India

Dr Ritu Gupta

Principal investigator

08170066875

ritugupta0102@gmail.com