Trial Outcomes & Findings for Efficacy of Film Modelling in Paediatric Dentistry (NCT NCT01908127)

Results Overview

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)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

50 participants

Primary outcome timeframe

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

Results posted on

2014-01-20

Participant Flow

September 2010- December 2010 paediatric clinic of dental school, Zahedan University of Medical Sciences

The parents of four the enrolled children declined the participation in the study

Participant milestones

Participant milestones
Measure	Tell- Show- do Procedure 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.	Film Modelling 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.
Overall Study STARTED	23	23
Overall Study COMPLETED	22	23
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy of Film Modelling in Paediatric Dentistry

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tell- Show- do Procedure n=23 Participants 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.	Film Modelling n=23 Participants 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.	Total n=46 Participants Total of all reporting groups
Age, Categorical <=18 years	23 Participants n=5 Participants	23 Participants n=7 Participants	46 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	4.9 years STANDARD_DEVIATION 1.17 • n=5 Participants	5 years STANDARD_DEVIATION 1.17 • n=7 Participants	4.95 years STANDARD_DEVIATION 1.17 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	14 Participants n=7 Participants	24 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	9 Participants n=7 Participants	22 Participants n=5 Participants
Region of Enrollment Iran, Islamic Republic of	23 participants n=5 Participants	23 participants n=7 Participants	46 participants n=5 Participants

PRIMARY outcome

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

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)

Outcome measures

Outcome measures
Measure	Tell- Show- do Procedure n=22 Participants 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.	Film Modelling n=23 Participants 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.
Behaviors of Children anxious behaviour quantification	0.97 units on a scale Standard Deviation 0.73	1.09 units on a scale Standard Deviation 0.99
Behaviors of Children cooperative behaviour quantification	2.95 units on a scale Standard Deviation 0.64	2.98 units on a scale Standard Deviation 0.67

SECONDARY outcome

Timeframe: before and after the injection of local anesthesia solution

The heart rate of children was measured before the injection of local anesthesia solution to save a baseline data and it was also measured after the injection to assess the effect of this dental stress.

Outcome measures

Outcome measures
Measure	Tell- Show- do Procedure n=22 Participants 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.	Film Modelling n=23 Participants 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.
Index of Heart Rate heart rate after the injection	110.40 beat per Min Standard Deviation 10.86	113 beat per Min Standard Deviation 13.86
Index of Heart Rate baseline heart rate	99.27 beat per Min Standard Deviation 9.17	102.73 beat per Min Standard Deviation 12.37

Adverse Events

Tell- Show- do Procedure

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Film Modelling

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Mehrsa Paryab

Tehran University of Medical Sciences

Phone: 00989121091675

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place