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Comparative evaluation of sedative, anxiolytic and post-operative effects of oral melatonin and nitrous oxide inhalation sedation in 5 to 8 year old children - an ELISA based study

Comparative evaluation of sedative, anxiolytic and post-operative effects of oral melatonin and nitrous oxide inhalation sedation in 5 to 8 year old children - an ELISA based study. - NIL

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/08/056173
Enrollment
78
Registered
2023-08-07
Start date
Unknown
Completion date
Unknown
Last updated
2023-08-21

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

Conditions

Health Condition 1: K04- Diseases of pulp and periapical tissues

Interventions

Intervention1: Nitrous Oxide Inhalation Sedation: Nitrous oxide (N2O) inhalation sedation is a commonly used method for managing anxiety and pain during dental procedures, especially for pediatric pat

Sponsors

I.T.S. Centre for Dental Studies and Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 5 to 8 year old healthy children with parental consent to participate in the study. Children indicated for extraction of primary mandibular molar involving administration of IANB. Children with no sensory or cognitive impairment. Children with Frank l Behaviour Rating 3 and 4.

Exclusion criteria

Exclusion criteria: Children with any medical or systemic disease. Children with mouth breathing habit. Children with Frankl Behaviour Rating 1 and 2.

Design outcomes

Primary

MeasureTime frame
The sedative & anxiolytic effect of oral melatonin can be comparable to Nitrous Oxide inhalation sedationTimepoint: baseline and immediately after intervention

Secondary

MeasureTime frame
Oral Melatonin can be used in pediatric dentistry to relieve anxietyTimepoint: baseline & immediately after intervention

Countries

India

Contacts

Public ContactDr Shailja Sinha

I.T.S. Centre for Dental Studies and Research

dr.sakshijoshi@its.edu.in7027082746

Outcome results

None listed

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