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The Effect of Parental Presence on Dental Fear

Phase 4
Completed
Conditions
Dental Fear
Interventions
Procedure: Restorative procedure
Drug: Maxillary infiltration anesthesia with 2%Lidocaine
Registration Number
NCT02619981
Lead Sponsor
Riyadh Colleges of Dentistry and Pharmacy
Brief Summary

150 children aged between five and seven years presenting for the first dental visit, whose parents consented to participate in the study were selected from patients reporting to the dental clinics Riyadh Colleges of Dentistry and Pharmacy using convenience sampling. Pulse rate for each patient was measured at different clinical situation starting from patient parent separation until end of appointment using a pulse oximeter, Data which collected was statistically analyzed using appropriate statistical analyses using SPSS ver.19 data processing software.

Detailed Description

150 children aged between five and seven years presenting for the first dental visit, whose parents consented to participate in the study were selected from patients reporting to the dental clinics Riyadh Colleges of Dentistry and Pharmacy using convenience sampling. Only children who were classified as anxious but able to cope were included in the study (Rating 2 on the Venham's scale).

Pulse rate for each patient was measured at six different clinical situations. 1) Baseline 2) Seating of the child at the chair, 3) Arrival of the dentist, 4) Administration of local anesthesia 5) During the procedure, 6) End of Appointment.

Based on the accompanying person the children were classified as children accompanied by mothers alone, children accompanied by fathers alone, children accompanied by both parents.

The behavior of the child at each situation was recorded using the modified Venham's scale at each interval. The heart rate and oxygen saturation were recorded using pulse oxymetry

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
150
Inclusion Criteria
  • No previous restorative dental experience
  • At least one maxillary posterior tooth requiring restorative care
  • Parental consent to participate in the study
Exclusion Criteria
  • Children with previous restorative dental experience
  • Children with intellectual disability
  • Children with diagnosed neurobehavioral disorders, including (but not limited to ), Autism spectrum disorders, learning disabilities, cerebral palsy, attention deficit hyperactivity disorder

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Father presentMaxillary infiltration anesthesia with 2%LidocaineChild seated at the dental chair, buccal maxillary infiltration anesthesia with 2%Lidocaine administered using a 27 gauge 21mm needle , restorative procedure completed , Father present
Both parents presentRestorative procedureChild seated at the dental chair, buccal maxillary infiltration anesthesia with 2%Lidocaine administered using a 27 gauge 21mm needle , restorative procedure completed , both parents present
Father presentRestorative procedureChild seated at the dental chair, buccal maxillary infiltration anesthesia with 2%Lidocaine administered using a 27 gauge 21mm needle , restorative procedure completed , Father present
Mother PresentRestorative procedureChild seated at the dental chair, buccal maxillary infiltration anesthesia with 2%Lidocaine administered using a 27 gauge 21mm needle , restorative procedure completed , Mother present
Mother PresentMaxillary infiltration anesthesia with 2%LidocaineChild seated at the dental chair, buccal maxillary infiltration anesthesia with 2%Lidocaine administered using a 27 gauge 21mm needle , restorative procedure completed , Mother present
Both parents presentMaxillary infiltration anesthesia with 2%LidocaineChild seated at the dental chair, buccal maxillary infiltration anesthesia with 2%Lidocaine administered using a 27 gauge 21mm needle , restorative procedure completed , both parents present
Primary Outcome Measures
NameTimeMethod
Child behavior - Subjective30min

Child behavior monitored using the Venham scale

Secondary Outcome Measures
NameTimeMethod
Child Behavior - Objective30 min

Child Behavior Monitored using Pulse oximeter

Trial Locations

Locations (1)

Riyadh Colleges of Dentistry and Pharmacy

🇸🇦

Riyadh, Saudi Arabia

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