The Effect of Parental Presence on Dental Fear

Riyadh Colleges of Dentistry and Pharmacy

Status and phase: Completed; Phase 4

Conditions: Dental Fear

Treatments: Drug: Maxillary infiltration anesthesia with 2%Lidocaine; Procedure: Restorative procedure

Study type: Interventional

Funder types: Other

Identifiers

NCT02619981

IRP/2012/48

Details and patient eligibility

About

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.

Full 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

Enrollment: 150 patients

Sex: All

Ages: 5 to 7 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 3 patient groups

Father present

Active Comparator group

Description:

Child seated at the dental chair, buccal maxillary infiltration anesthesia with 2%Lidocaine administered using a 27 gauge 21mm needle , restorative procedure completed , Father present

Treatment:

Drug: Maxillary infiltration anesthesia with 2%Lidocaine

Procedure: Restorative procedure

Mother Present

Active Comparator group

Description:

Child seated at the dental chair, buccal maxillary infiltration anesthesia with 2%Lidocaine administered using a 27 gauge 21mm needle , restorative procedure completed , Mother present

Treatment:

Drug: Maxillary infiltration anesthesia with 2%Lidocaine

Procedure: Restorative procedure

Both parents present

Active Comparator group

Description:

Child 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

Treatment:

Drug: Maxillary infiltration anesthesia with 2%Lidocaine

Procedure: Restorative procedure