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

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.

Study Overview

• Status: Completed
• Conditions: Dental Fear
• Intervention / Treatment: Procedure: Restorative procedure; Drug: Maxillary infiltration anesthesia with 2%Lidocaine

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

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Phase 4

Contacts and Locations

Study Locations

• Saudi Arabia
  • Riyadh, Saudi Arabia
    • Riyadh Colleges of Dentistry and Pharmacy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 7 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Father present; 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	Procedure: Restorative procedure; A restorative dental procedure requiring maxillary buccal infiltration anesthesia, and not exceeding 30 minutes of working time; Other Names: Dental Filling; Drug: Maxillary infiltration anesthesia with 2%Lidocaine; 1.8ml of 2% Lidocaine with adrenaline administered using a 27 gauge 21mm needle; Other Names: 2% Lignociane
Active Comparator: Mother Present; 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	Procedure: Restorative procedure; A restorative dental procedure requiring maxillary buccal infiltration anesthesia, and not exceeding 30 minutes of working time; Other Names: Dental Filling; Drug: Maxillary infiltration anesthesia with 2%Lidocaine; 1.8ml of 2% Lidocaine with adrenaline administered using a 27 gauge 21mm needle; Other Names: 2% Lignociane
Active Comparator: Both parents present; 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	Procedure: Restorative procedure; A restorative dental procedure requiring maxillary buccal infiltration anesthesia, and not exceeding 30 minutes of working time; Other Names: Dental Filling; Drug: Maxillary infiltration anesthesia with 2%Lidocaine; 1.8ml of 2% Lidocaine with adrenaline administered using a 27 gauge 21mm needle; Other Names: 2% Lignociane

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Child behavior - Subjective	Child behavior monitored using the Venham scale	30min

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Child Behavior - Objective	Child Behavior Monitored using Pulse oximeter	30 min

Collaborators and Investigators

• Sponsor: Riyadh Colleges of Dentistry and Pharmacy
• Investigators: Study Director: Hezekiah Mosadomi, DMD, Riyadh Colleges of Dentistry and Pharmacy

Publications and helpful links

General Publications

• Cox IC, Krikken JB, Veerkamp JS. Influence of parental presence on the child's perception of, and behaviour, during dental treatment. Eur Arch Paediatr Dent. 2011 Aug;12(4):200-4. doi: 10.1007/BF03262807.
• Afshar H, Baradaran Nakhjavani Y, Mahmoudi-Gharaei J, Paryab M, Zadhoosh S. The Effect of Parental Presence on the 5 year-Old Children's Anxiety and Cooperative Behavior in the First and Second Dental Visit. Iran J Pediatr. 2011 Jun;21(2):193-200.
• Al-Shalan TA, Al-Musa BA, Al-Khamis AM. Parents' attitude towards children's first dental visit in the College of Dentistry, Riyadh, Saudi Arabia. Saudi Med J. 2002 Sep;23(9):1110-4.
• Arathi R, Ashwini R. Parental presence in the dental operatory-parent's point of view. J Indian Soc Pedod Prev Dent. 1999 Dec;17(4):150-5.
• Marcum BK, Turner C, Courts FJ. Pediatric dentists' attitudes regarding parental presence during dental procedures. Pediatr Dent. 1995 Nov-Dec;17(7):432-6.

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: November 27, 2015
• First Submitted That Met QC Criteria: November 30, 2015
• First Posted (Estimate): December 2, 2015

Study Record Updates

• Last Update Posted (Estimate): December 2, 2015
• Last Update Submitted That Met QC Criteria: November 30, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: IRP/2012/48