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A Study Comparing Virtual Reality-Based Distraction and Sedation for Reducing Anxiety and Pain During Dental Injection in Children with Sensitive Tooth Enamel Defects

Comparative Evaluation of XR-Based Interactive Behavior Guidance Module and Conscious Sedation on Anxiety and Pain in Children with MIH during Local Anaesthesia Administration: A Randomized Controlled Trial - NIL

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/05/110114
Enrollment
66
Registered
2026-05-06
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

Health Condition 1: K049- Other and unspecified diseases ofpulp and periapical tissues

Interventions

Intervention1: Conscious Sedation with local anesthesia in MIH patients: The dentist will give LA under conscious sedation with nitrous oxide oxygen in patients with MIH. FLACC pain scale will be rec

Sponsors

Dr Shailja Agarwal
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1)Patient aged 9-14 years 2)Patients with a clinically diagnosed MIH affecting both maxillary and mandibular permanent molars 3)Patients requiring pulp therapy treatment under local anesthesia for the affected teeth (no allergy to anesthetics/sulfite) 4)Children free of any systemic disease or special health care needs. 5)Children with reasonable cooperation in dental treatment (3 or 4 on Frankl behavior rating scale) 6)Written informed consent from parents and guardians

Exclusion criteria

Exclusion criteria: 1.Patients taking medication that affects dental health 2.Patients with allergies or contraindications to local anesthesia 3.Inflammation/ lesion at the injection site

Design outcomes

Primary

MeasureTime frame
FLACC pain scale , MCDASf anxiety scale, Heart rate and SpO2Timepoint: At baseline and after 2 minutes of LA administration.

Secondary

MeasureTime frame
nilTimepoint: nil

Countries

India

Contacts

Public ContactDr Shailja Agarwal

Manav Rachna Dental College

tanunangia.sds@mrei.ac.in9999384333

Outcome results

None listed

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