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Completed

NCT Number: NCT02619981

The Effect of Parental Presence on Dental Fear

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.

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Key information

Conditions

Age range

5 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Riyadh Colleges of Dentistry and Pharmacy

Riyadh, Saudi Arabia

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Restorative procedure

Procedure

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

Other names: Dental Filling

Maxillary infiltration anesthesia with 2%Lidocaine

Drug

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

Other names: 2% Lignociane

Primary outcomes

  1. Child behavior - Subjective

    Time frame: 30min

    Child behavior monitored using the Venham scale

Secondary outcomes

  1. Child Behavior - Objective

    Time frame: 30 min

    Child Behavior Monitored using Pulse oximeter

Sponsors and collaborators

Lead sponsor

Riyadh Colleges of Dentistry and Pharmacy

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Dec 2, 2015
Registry last updated
Dec 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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