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A wrap to scrap the restraint:A Novel stabilizing device

Comparative evaluation of attitude and perception of parents for the use of Papoose board and Comfy wrap physical restraint as a behaviour guidance technique in pediatric patients during dental procedure – A crossover study - NIL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/06/069255
Enrollment
40
Registered
2024-06-20
Start date
Unknown
Completion date
Unknown
Last updated
2025-06-24

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

Conditions

Health Condition 1: K029- Dental caries, unspecified

Interventions

Intervention1: Use of comfy wrap restraint: First Comfy wrap will be used as a physical restraint & local anesthesia will be administered by the operator for the required procedure After the procedure

Sponsors

Dr Ankita Tapkir
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients with age group 4-7 years of age. Patients with Frankl’s behaviour rating scale 1 & 2. Patient requiring local anesthesia for dental treatment for two or more procedures. Patients with informed parental consent.

Exclusion criteria

Exclusion criteria: Patient with history of allergy or asthma. Patient with special health care needs. Patient with any debilitating disease. Patients with Frankl’s behaviour rating scale 3 & 4. Patient who is a known allergic to local anesthetic agent.

Design outcomes

Primary

MeasureTime frame
To evaluate the attitude and perception of parents for the use of Papoose board as a physical restraint during dental treatment in pediatric patients. To evaluate the attitude and perception of parents for the use of Comfy-wrap as a physical restraint during dental treatment in pediatric patients. Timepoint: nil

Secondary

MeasureTime frame
To evaluate and compare the attitude and perception of parents for the use of Papoose board and Comfy-wrap as a physical restraint during dental treatment in pediatric patientsTimepoint: nil

Countries

India

Contacts

Public ContactDr Nilesh Rathi

Dr D Y Patil Dental College and Hospital, Pimpri, Pune

nilesh.rathi@dpu.edu.in9960100010

Outcome results

None listed

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