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Behavior Management Device to reduce dental anxiety in children.

Comparative evaluation of the effectiveness of innovative â??Biofeedback Dental Anxiety Regulatorâ?? and Virtual Reality Eyeglasses for reducing dental anxiety during dental restorative procedure in children.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/07/044137
Enrollment
42
Registered
2022-07-19
Start date
Unknown
Completion date
Unknown
Last updated
2022-08-02

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

Conditions

Health Condition 1: - Health Condition 2: - Health Condition 3: F408- Other phobic anxiety disorders

Interventions

Intervention1: Biofeedback Dental Anxiety Regulator: Behavior management device to reduce dental anxiety in children during dental restorative procedure. Control Intervention1: Virtual Reality Eyeglas

Sponsors

Dr Ritesh Kalaskar
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Healthy children with the non-contributory medical history 2. Children falling under Franklâ??s behavior rating scale 3 and 4 3. Children with class I, Class II and Class V cavities on primary maxillary or mandibular molars and canines 4. Each patient should have a minimum of 2-3 cavities on each side of the jaw. 5. Clinically the involved tooth should not have pulpal exposure 6. Radiographically, the caries should not extend to the pulp chamber 7. The tooth/teeth should be either asymptomatic or have a history of reversible pulpitis. 8. Children and their parents who are willing to participate in the study

Exclusion criteria

Exclusion criteria: 1. Children with special health care needs. 2. Children with carious lesion approaching or extending into the pulp (clinically and radiographically) 3. Children with a history of abscess or sinus tract formation, swelling, non-restorable teeth or mobile teeth. 4. Patients and their parents who are unwilling to participate in the study

Design outcomes

Primary

MeasureTime frame
To evaluate and compare heart rate, oxygen saturation and blood pressure of children during dental procedure using biofeedback dental anxiety regulator To evaluate and compare pulse heart rate, oxygen saturation and blood pressure of children during dental procedure using virtual reality eyeglasses. To evaluate and compare dental anxiety of children of both the groups during dental procedure To evaluate and compare dental anxiety of the children of both the groups by another investigator.Timepoint: 1.before the procedure 2.during the procedure at an interval of 3 mins 3.after the procedure—

Secondary

MeasureTime frame
not applicableTimepoint: not applicable—

Countries

India

Contacts

Public ContactDr Urvi Premji Gala

Government Dental College and Hospital Nagpur

riteshpedo1@gmail.com8550938585

Outcome results

None listed

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