The Effect of Parental Presence on Dental Fear

Study Overview
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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

Official Title
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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

Conditions
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Dental Fear

Intervention / Treatment
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* Procedure: Restorative procedure
* Drug: Maxillary infiltration anesthesia with 2%Lidocaine


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |