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The Effect of Parental Presence on Dental Fear

NCT ID: NCT02619981

Last Updated: 2015-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2015-02-28

Brief Summary

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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.

Detailed Description

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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

Conditions

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Dental Fear

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Restorative procedure

Intervention Type PROCEDURE

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

Maxillary infiltration anesthesia with 2%Lidocaine

Intervention Type DRUG

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

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

Group Type ACTIVE_COMPARATOR

Restorative procedure

Intervention Type PROCEDURE

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

Maxillary infiltration anesthesia with 2%Lidocaine

Intervention Type DRUG

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

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

Group Type ACTIVE_COMPARATOR

Restorative procedure

Intervention Type PROCEDURE

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

Maxillary infiltration anesthesia with 2%Lidocaine

Intervention Type DRUG

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

Interventions

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Restorative procedure

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

Intervention Type PROCEDURE

Maxillary infiltration anesthesia with 2%Lidocaine

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

Intervention Type DRUG

Other Intervention Names

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Dental Filling 2% Lignociane

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Riyadh Colleges of Dentistry and Pharmacy

OTHER

Sponsor Role lead

Responsible Party

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Dr Sharat Pani

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hezekiah Mosadomi, DMD

Role: STUDY_DIRECTOR

Riyadh Colleges of Dentistry and Pharmacy

Locations

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Riyadh Colleges of Dentistry and Pharmacy

Riyadh, , Saudi Arabia

Site Status

Countries

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Saudi Arabia

References

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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.

Reference Type BACKGROUND
PMID: 21806904 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23056787 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12370724 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10863512 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 8786909 (View on PubMed)

Other Identifiers

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IRP/2012/48

Identifier Type: -

Identifier Source: org_study_id