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"Comparison of effect of a vibratory machine against a gel that reduces pain of dental extraction before injection in the mouth of children aged 9-11 years ."

"Comparative evaluation of effectiveness of vibratory delivery system versus topical anesthetic gel in pain reduction during inferior alveolar nerve block in children aged 9-11 years: A split-mouth randomized controlled clinical trial."

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/10/037385
Enrollment
20
Registered
2021-10-20
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-01

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

Conditions

Health Condition 1: K041- Necrosis of pulp

Interventions

Intervention1: Vibratory Device: It is a vibratory device that is placed at the site of injection before administration of local anesthetic solution in children. Control Intervention1: Topical Anesthe

Sponsors

Dr Priyanka Nagnath Wakude
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Parents and children willing to participate in the study. 2.Children who requires bilateral Inferior alveolar nerve block injections. 3.Medically and mentally healthy children aged 9-11 years. 4.Children whose behaviour will be definitely positive and positive according to Frankl Behaviour Scale.

Exclusion criteria

Exclusion criteria: 1.Children with systemic illness and chronic disease. 2.Children with history of previous hospitalization or surgery. 3.Children with autism, neurological behavior disorders such as attention deficit and hyperactive disorder or learning disabilities, mental retardation, hearing and speech disorders. 4.Children with any special health care needs. 5.Children with a history of bad dental experiences during local anesthetic injection. 6.Any problem associated with the site of application of vibratory system or topical anesthetic agent.

Design outcomes

Primary

MeasureTime frame
1. To assess the pain reduction in 9-11 years children using FLACC scale and Wong-Baker Faceâ??s Pain Rating Scale (WBFPRS).Timepoint: Immediate—

Secondary

MeasureTime frame
1.To compare the effectiveness of vibratory delivery system versus topical anesthetic gel in pain reduction during inferior alveolar nerve block in children aged 9-11 years.Timepoint: Immediate—

Countries

India

Contacts

Public ContactDr Priyanka Nagnath Wakude

Sinhgad Dental College and Hospital, Pune

rupat13@yahoo.com8871963896

Outcome results

None listed

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