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Evaluation of pain perception and behavioural outcome in 5-9 year old children undergoing routine filling procedure with injection, without injection and with laughing gas sedation : A Randomized study

Evaluation Of Pain Perception And Behavioural Outcome In Children Undergoing Routine Restorative Treatment Without Local Analgesia, With Local Analgesia And With Nitrous Oxide- Oxygen Inhalation Sedation: A Randomized Study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/06/112159
Enrollment
42
Registered
2026-06-08
Start date
Unknown
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Health Condition 1: K025- Dental caries on pit and fissure surface Health Condition 2: Z008- Encounter for other general examination

Interventions

Intervention1: nitrous oxide oxygen inhalation sedation: 10-70% nitrous oxide administerd via inhalational route ie. through nose, for not more than 30 minutes Control Intervention1: local anesthesia:

Sponsors

Mehak Jindal
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: • Healthy patients (ASA I), aged 5-9 years. • Patient exhibiting Franklâ??s positive and definitely positive behaviour. • Patient presenting with occlusal carious lesion with no pulp involvement and in need of Class I restorations on one or more than one mandibular primary molar. The included depth of the lesion will be diagnosed from pre-operative radiographs as follows: 1. C1: caries lesion in the enamel for upto one-third into dentin. 2. C2: caries lesion in the enamel for less than two-third into dentin.

Exclusion criteria

Exclusion criteria: • Medically and mentally compromised children. • Children with a history of significant behaviour management issues. • Children presenting with Class II, Class III, Class IV and Class V caries • Children presenting possible pulp involvement in caries lesions.

Design outcomes

Primary

MeasureTime frame
Pain perceptionTimepoint: at end of procedure

Secondary

MeasureTime frame
Behavioral outcomeTimepoint: at start & end of procedure

Countries

India

Contacts

Public ContactMehak Jindal

Baba Jaswant Singh Dental College, Hospital and Research Institute

harsimrat512@gmail.com9915956934

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Aug 10, 2026