Efficacy of Film Modelling in Paediatric Dentistry

NCT01908127 | Completed Results DMC

• 1 other identifier: 1382
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the effect of Filmed modelling in comparison with commonly used Tell-Show-Do technique on the anxious and cooperative behaviour of 4-6 years old children during dental practice.

Conditions

Cooperative Behaviour; Dental Anxiety

Keywords

film modelling; dental anxiety; cooperative behaviour; children

Outcome Measures

Primary Outcomes (1)

• Behaviors of Children

  A video-camera was focused started to record child's behavior. The recorded video tapes were independently evaluated by 2 paediatric dentists who were blind to the grouping of the children. Children's anxiety reactions and cooperative behaviours were scored based on venham scale and Frankle Index ,respectively. quantification was performed at the injection of local anaesthesia and at the beginning of the tooth preparation. An average of both two time points scoring was used. Table 1: Venham 6-point Index 0 = Relaxed: 1 = Uneasy: 2 = Tense: 3 = Reluctant: 4 = Interference: 5 = Out of contact Table 2: Frankle 4-point Index 1:Definitely Negative ( uncooperative,Refusal of treatment ) , 2:Negative ( some evidence of negative attitude but not pronounced) , 3:Positive ( Acceptance of treatment, at times cautious) , 4:Definitely Positive( Good rapport with the dentist)

  participants followed for the duration of examination and treatment appointment, an expected average of 3 weeks

Secondary Outcomes (1)

• Index of Heart Rate

  before and after the injection of local anesthesia solution

Study Arms (2)

tell- show- do procedure

ACTIVE COMPARATOR

Group I (Tell- Show- Do Group): Tell-Show-Do, prophylaxis with paste and rubber cap and fluoride therapy was performed by the dentist for each participant in the operation room. In the second session,injection of loal anesthesia solution including a mandibular alveolar nerve block technique and the occlusal cavity preparation was performed.

Behavioral: tell- show- do; Drug: injection of local anesthesia solution; Procedure: occlusal cavity preparation

film modelling

EXPERIMENTAL

Group II (Filmed modelling Group): the children were directed to a quiet and comfort room to watch a film presented by a dental assistant. The film showed that the same procedure consisted of Tell-Show-Do, prophylaxis with paste and rubber cap and fluoride therapy was performed on a 5-years-old child model with a time of 20 minutes. The child in the film was cooperative and was reinforced by a reward at the end of the procedure. In the second session, injection of loal anesthesia solution including a mandibular alveolar nerve block technique and the occlusal cavity preparation was performed.

Behavioral: film modelling; Drug: injection of local anesthesia solution; Procedure: occlusal cavity preparation

Interventions

tell- show- do BEHAVIORAL

Children came in the operation room. Tell-Show-Do, prophylaxis with paste and rubber cap and fluoride therapy was performed by the dentist for each participant to increase their familiarity with dental procedures. The duration of the appointment was about 20 minutes and constant for all children.

tell- show- do procedure

film modelling BEHAVIORAL

the children were directed to a quiet and comfort room to watch a film presented by a dental assistant. The film showed that the same procedure consisted of Tell-Show-Do, prophylaxis with paste and rubber cap and fluoride therapy was performed on a 5-years-old child model with a time of 20 minutes. The child in the film was cooperative and was reinforced by a reward at the end of the procedure.

film modelling

injection of local anesthesia solution DRUG

A topical anesthesia and injection of local anesthesia solution using mandibular alveolar nerve block technique was performed by the dentist

film modelling; tell- show- do procedure

occlusal cavity preparation PROCEDURE

the occlusal cavity was prepared for pulpotomy and restoration of the teeth

film modelling; tell- show- do procedure

Eligibility Criteria

• Age: 4 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• children aged 4-6 years
• caries lesion in one of the primary mandibular molars needs to pulpotomy and restoration treatment.

You may not qualify if:

• children with systemic diseases and developmental disorders
• previous experience of hospitalization

Sponsors & Collaborators

• Zahedan University of Medical Sciences: lead

Study Sites (1)

Zahedan Dental School

Zahedan, Iran

Location

Limitations and Caveats

providing a quiet environment and patient sampling were the most important limitations.

Results Point of Contact

• Title: Dr. Mehrsa Paryab
• Organization: Tehran University of Medical Sciences

drmparyab@yahoo.com

00989121091675

Study Officials

• mehrsa paryab, Dr

  dental school, tehran university of medical sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assisstant professor

Study Record Dates

• First Submitted: July 17, 2013
• First Posted: July 25, 2013
• Study Start: September 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: April 1, 2011
• Last Updated: January 20, 2014
• Results First Posted: January 20, 2014

Record last verified: 2013-12

Locations

IR (1)