NCT02619981

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 2012

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 27, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 2, 2015

Completed
Last Updated

December 2, 2015

Status Verified

November 1, 2015

Enrollment Period

2 years

First QC Date

November 27, 2015

Last Update Submit

November 30, 2015

Conditions

Dental Fear

Outcome Measures

Primary Outcomes (1)

  • Child behavior - Subjective

    Child behavior monitored using the Venham scale

    30min

Secondary Outcomes (1)

  • Child Behavior - Objective

    30 min

Study Arms (3)

Father present

ACTIVE COMPARATOR

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 procedureDrug: Maxillary infiltration anesthesia with 2%Lidocaine

Mother Present

ACTIVE COMPARATOR

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 procedureDrug: Maxillary infiltration anesthesia with 2%Lidocaine

Both parents present

ACTIVE COMPARATOR

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 procedureDrug: Maxillary infiltration anesthesia with 2%Lidocaine

Interventions

Restorative procedurePROCEDURE

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

Also known as: Dental Filling
Both parents presentFather presentMother Present
Maxillary infiltration anesthesia with 2%LidocaineDRUG

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

Also known as: 2% Lignociane
Both parents presentFather presentMother Present

Eligibility Criteria

Age5 Years - 7 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • No previous restorative dental experience
  • At least one maxillary posterior tooth requiring restorative care
  • Parental consent to participate in the study

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riyadh Colleges of Dentistry and Pharmacy

Riyadh, Saudi Arabia

Location

Related Publications (5)

  • 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.

    PMID: 21806904BACKGROUND

  • 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.

    PMID: 23056787BACKGROUND

  • 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.

    PMID: 12370724BACKGROUND

  • 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.

    PMID: 10863512BACKGROUND

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

    PMID: 8786909BACKGROUND

Study Officials

  • Hezekiah Mosadomi, DMD

    Riyadh Colleges of Dentistry and Pharmacy

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 27, 2015

First Posted

December 2, 2015

Study Start

November 1, 2012

Primary Completion

November 1, 2014

Study Completion

February 1, 2015

Last Updated

December 2, 2015

Record last verified: 2015-11

Locations

SA(1)