The Effect of Parental Presence on Dental Fear

Sponsor
Riyadh Colleges of Dentistry and Pharmacy (Other)
Overall Status
Completed
CT.gov ID
NCT02619981
Collaborator
(none)
150
1
3
27
5.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Restorative procedure
  • Drug: Maxillary infiltration anesthesia with 2%Lidocaine
Phase 4

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 Design

Study Type:
Interventional
Actual Enrollment :
150 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Diagnostic
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
Study Start Date :
Nov 1, 2012
Actual Primary Completion Date :
Nov 1, 2014
Actual Study Completion Date :
Feb 1, 2015

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. Child behavior - Subjective [30min]

      Child behavior monitored using the Venham scale

    Secondary Outcome Measures

    1. Child Behavior - Objective [30 min]

      Child Behavior Monitored using Pulse oximeter

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    5 Years to 7 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Riyadh Colleges of Dentistry and Pharmacy Riyadh Saudi Arabia

    Sponsors and Collaborators

    • Riyadh Colleges of Dentistry and Pharmacy

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Dr Sharat Pani, Assistant Professor, Riyadh Colleges of Dentistry and Pharmacy
    ClinicalTrials.gov Identifier:
    NCT02619981
    Other Study ID Numbers:
    • IRP/2012/48
    First Posted:
    Dec 2, 2015
    Last Update Posted:
    Dec 2, 2015
    Last Verified:
    Nov 1, 2015
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 2, 2015