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The Effect of Parental Presence on Dental Fear

An Objective Assessment of Dental Fear, and the Influence of the Parental Presence on the Behavior of Anxious Children on Their First Restorative Dental Visit

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02619981
Enrollment
150
Registered
2015-12-02
Start date
2012-11-30
Completion date
2015-02-28
Last updated
2015-12-02

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

Conditions

Dental Fear

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

Interventions

A restorative dental procedure requiring maxillary buccal infiltration anesthesia, and not exceeding 30 minutes of working time

DRUGMaxillary infiltration anesthesia with 2%Lidocaine

1.8ml of 2% Lidocaine with adrenaline administered using a 27 gauge 21mm needle

Sponsors

Riyadh Colleges of Dentistry and Pharmacy
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
5 Years to 7 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Child behavior - Subjective30minChild behavior monitored using the Venham scale

Secondary

MeasureTime frameDescription
Child Behavior - Objective30 minChild Behavior Monitored using Pulse oximeter

Countries

Saudi Arabia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 12, 2026