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Study in patients with braces to compare the effect of two types of glue on the development of white marks on teeth

Comparison of bioactive and conventional adhesives on white spot lesion formation during fixed orthodontic treatment ? a randomized clinical trial. - NILL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/08/093577
Enrollment
15
Registered
2025-08-25
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-15

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

Conditions

Health Condition 1: K038- Other specified diseases of hard tissues of teeth

Interventions

Intervention1: BIOACTIVE ADHESIVE: In the bioactive adhesive group, orthodontic brackets will be bonded using ACTIVA BioACTIVE Restorative, a light-cured, resin-modified bioactive material that releas

Sponsors

DR PRERNA
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients aged 12?25 years irrespective of gender. 2.Fixed orthodontic treatment with extraction or non-extraction treatment plan.

Exclusion criteria

Exclusion criteria: 1.Patients with poor oral hygiene or systemic diseases affecting salivary flow. 2.Patients on medications affecting oral microbiota or calcium metabolism. 3.Patients not willing to participate in the study. 4.No pre-existing enamel lesions or restorations on labial surfaces of teeth.

Design outcomes

Primary

MeasureTime frame
The primary outcome of this study is to compare the two adhesives in minimizing the formation of white spot lesions during fixed orthodontic appliance therapy, evaluated over a 6-months and 12 months period.Timepoint: T0- Before treatment T1- after 6 months T2- After 12 months

Secondary

MeasureTime frame
Secondary Outcomes include the severity and distribution of WSLs (mesial, distal, gingival, or occlusal to the bracket). These will be documented to assess lesion pattern distribution using Quantitative Light-induced Fluorescence (QLF).Timepoint: T0- Before treatment T1- after 6 months T2- After 12 months

Countries

India

Contacts

Public ContactDr Vilas Samrit

AIIMS New Delhi

vilassamrit@live.in9899503560

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026