Condition category
Oral Health
Date applied
25/12/2020
Date assigned
07/01/2021
Last edited
08/01/2021
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

Background and study aims
A dental dam is used in dentistry to isolate the tooth being operated on from the rest of the mouth to improve dentist working conditions and for patient protection. The aim of this study is to analyze the behavior of children during dental care with or without a dam.

Who can participate?
All children with temporary molar tooth decay

What does the study involve?
Patients are randomly allocated to receive treatment using the rubber dental dam or using a cotton wool dam. During the procedure the behavior and heart rate of the patient is measured.

What are the possible benefits and risks of participating?
None

Where is the study run from?
CHU Saint-Pierre (Belgium)

When is the study starting and how long is it expected to run for?
October 2017 to March 2018

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
Tania Vanhee
Tania.Vanhee@ulb.be

Trial website

Contact information

Type

Scientific

Primary contact

Dr Tania Vanhee

ORCID ID

https://orcid.org/0000-0001-7608-4368

Contact details

Université Libre de Bruxelles
Faculté de Médecine
CP 622 808 Route de Lennik
Brussels
1070
Belgium
+32 (0)478613102
Tania.Vanhee@ulb.be

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

B076201734515

Study information

Scientific title

The effect on behavior and heart rate of using isolation with a rubber dam or isolation with cotton rolls in children with caries on primary molars, a randomized study

Acronym

Study hypothesis

This study aims to determine the behavioral and physiological indicators of stress in children during dental care with or without a rubber dam with the hypothesis that rubber dam decreases stress. The null hypothesis is that there is no difference between the outcomes measured in the two groups.

Ethics approval

Approved 24/11/2017, Ethics committee of CHU Saint-Pierre (322, rue Haute, 1000, Brussels, Belgium; no telephone number provided; christopher_vandenberghe@stpierre-bru.be), ref: B076201734515

Study design

Interventional randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

See additional files

Condition

Stress in children during dental care

Intervention

Based on the sample size of comparable studies, a cohort of 51 children, 30 boys and 21 girls, from 3 to 10 years old is recruited form patients consulting in the pediatric dentistry department of CHU Saint-Pierre, César de Paepe site (Brussels, Belgium). Patients needing operative treatment on at least one primary molar are eligible to participate. Children with infected or mobile decayed teeth as well as those outside the age range studied are excluded.
The patients included in the study are randomized at the beginning of the day by random draw and assigned either: the test group with rubber dam and the control group with cotton roll isolation. Treatments are performed by 12 practitioners belonging to the pediatric dentistry team. All treatments are followed by a single observer who collected the data.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measure

Behavior measured using the modified Venham hetero-evaluation scale at five different time points (T0 to T4). T0: patient installed in the dental chair, T1: during local anesthesia, T2: before placing isolation, T3: with isolation installed and T4: during the treatment

Secondary outcome measures

Heart rate recorded using a Digital Finger Pulse Oxygen Saturation Monitor OLED display (Elera, China) at five different time points (T0 to T4). T0: patient installed in the dental chair, T1: during local anesthesia, T2: before placing isolation, T3: with isolation installed and T4: during the treatment

Overall trial start date

09/10/2017

Overall trial end date

07/03/2018

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Patients aged 3 - 10 years, needing operative treatment on at least one primary molar

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

51

Total final enrolment

51

Participant exclusion criteria

1. Children with infected or mobile decayed teeth
2. Outside the age range studied

Recruitment start date

17/11/2017

Recruitment end date

07/03/2018

Locations

Countries of recruitment

Belgium

Trial participating centre

CHU Saint-Pierre
Pediatric Dentistry department Stomatology service César de Paepe site 11, Alexiensstreet
Brussels
1000
Belgium

Sponsor information

Organisation

Université Libre de Bruxelles

Sponsor details

Faculté de Médecine
808 Route de Lennik
Brussels
1070
Belgium
+32 (0)25556799
admin.medecine@ulb.be

Sponsor type

University/education

Website

http://www.ulb.ac.be/

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal

IPD sharing statement:
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.

Intention to publish date

01/01/2021

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

08/01/2021: The participant information sheet has been uploaded. 07/01/2021: Trial's existence confirmed by the ethics committee of CHU Saint-Pierre.