A clinical experiment to compare the clinical survival (i.e., bond failure rate) of a novel color-changing orthodontic adhesive material over a six-month duration Comparing Orthofix Pro with traditional orthodontic adhesive Enlight V

Clinical Evaluation of a New Colour Changing Orthodontic Adhesive Orthofix Pro Versus Conventional Orthodontic Adhesive Enlight V: In Vivo Study - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/10/075464

Enrollment

Registered

2024-10-17

Start date

Unknown

Completion date

Unknown

Last updated

2026-02-02

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

Conditions

Health Condition 1: K002- Abnormalities of size and form ofteeth

Interventions

Intervention1: Orthofix Pro: Orthofix Pro- Orthodontic Adhesive with Chroma Technology (Light Cure Orthodontic Colour Changing Bonding System) - 2x3 grams - R&D Trial Pack bearing Batch No. 20- R-1 C

Eligibility

Inclusion criteria

Inclusion criteria: Complete permanent dentition. Patient requiring fixed appliance therapy in both arches. Both extraction and non-extraction cases. Absence of labial or buccal restoration. No history of active or previousorthodontic treatment. No hypoplastic lesion in enamel. Good oral hygiene.

Exclusion criteria

Exclusion criteria: Patient with congenital enamel defects. Patient with missing tooth. Patient with craniofacial anomalies. Patient with restorations and crown. Patient who requires orthognathic surgical treatment. Patient who presents with traumatic occlusion

Design outcomes

Primary

Measure	Time frame
clinical survival (i.e. bond failure rate) over a six-month period of a new color changing orthodontic adhesive Orthofix Pro versus conventional orthodontic adhesive Enlight V.Timepoint: 6 Months	—

Secondary

Measure	Time frame
To determine the mode of bracket failure according to adhesive remnant index (ARI)Timepoint: 6 Months;To determine the in-vivo orthodontic bracket failure rates with respect to patientâ??s gender, type of tooth, type of quadrant, arch and position of tooth (anterior and posterior)Timepoint: 6 Months	—

Countries

India

Contacts

Public ContactDr Priya Kumari

Hitkarini Dental College and Hospital

sarvraj.kohli@gmail.com9425152568

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026