Clinical Trials Directory

Trials / Completed

CompletedNCT02619981

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
Phase
Phase 4
Study type
Interventional
Enrollment
150 (actual)
Sponsor
Riyadh Colleges of Dentistry and Pharmacy · Academic / Other
Sex
All
Age
5 Years – 7 Years
Healthy volunteers
Accepted

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

Conditions

Interventions

TypeNameDescription
PROCEDURERestorative procedureA restorative dental procedure requiring maxillary buccal infiltration anesthesia, and not exceeding 30 minutes of working time
DRUGMaxillary infiltration anesthesia with 2%Lidocaine1.8ml of 2% Lidocaine with adrenaline administered using a 27 gauge 21mm needle

Timeline

Start date
2012-11-01
Primary completion
2014-11-01
Completion
2015-02-01
First posted
2015-12-02
Last updated
2015-12-02

Locations

1 site across 1 country: Saudi Arabia

Source: ClinicalTrials.gov record NCT02619981. Inclusion in this directory is not an endorsement.