The Effect of Parental Presence on Dental Fear

Dental Fear Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02619981
• Other study ID #: IRP/2012/48
• Status: Completed
• Phase: Phase 4
• First received: November 27, 2015
• Last updated: November 30, 2015
• Start date: November 2012
• Est. completion date: February 2015

Study information

• Verified date: November 2015
• Source: Riyadh Colleges of Dentistry and Pharmacy
• Contact: n/a
• Is FDA regulated: No
• Health authority: Saudi Arabia: Ministry for Higher Education
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: February 2015
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 5 Years to 7 Years

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Dental Fear

Intervention

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

Drug:
• Maxillary infiltration anesthesia with 2%Lidocaine
1.8ml of 2% Lidocaine with adrenaline administered using a 27 gauge 21mm needle

Locations

Country	Name	City	State
Saudi Arabia	Riyadh Colleges of Dentistry and Pharmacy	Riyadh

Sponsors (1)

Lead Sponsor	Collaborator
Riyadh Colleges of Dentistry and Pharmacy

Country where clinical trial is conducted

Saudi Arabia, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Marcum BK, Turner C, Courts FJ. Pediatric dentists' attitudes regarding parental presence during dental procedures. Pediatr Dent. 1995 Nov-Dec;17(7):432-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Child behavior - Subjective	Child behavior monitored using the Venham scale	30min	No
Secondary	Child Behavior - Objective	Child Behavior Monitored using Pulse oximeter	30 min	No