Behavior of children during dental care using a rubber dam or cotton roll to isolate the tooth

ISRCTN	ISRCTN15046229
DOI	https://doi.org/10.1186/ISRCTN15046229
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	B076201734515
Sponsor	Université Libre de Bruxelles
Funder	Investigator initiated and funded

Submission date: 25/12/2020
Registration date: 07/01/2021
Last edited: 28/02/2023

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Oral Health

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Dr Tania Vanhee
Scientific

Université Libre de Bruxelles
Faculté de Médecine
CP 622 808 Route de Lennik
Brussels
1070
Belgium

ORCID ID	0000-0001-7608-4368
Phone	+32 (0)478613102
Email	Tania.Vanhee@ulb.be

Study information

Primary study design	Interventional
Study design	Interventional randomized controlled trial
Secondary study design	Randomised controlled trial
Participant information sheet	ISRCTN15046229_PIS.docx
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
Study objectives	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(s)	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
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	07/03/2018

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	3 Years
Upper age limit	10 Years
Sex	All
Target sample size at registration	51
Total final enrolment	51
Key inclusion criteria	Patients aged 3 - 10 years, needing operative treatment on at least one primary molar
Key exclusion criteria	1. Children with infected or mobile decayed teeth 2. Outside the age range studied
Date of first enrolment	17/11/2017
Date of final enrolment	07/03/2018

Locations

Countries of recruitment

Belgium

Study participating centre

CHU Saint-Pierre

Pediatric Dentistry department
Stomatology service
César de Paepe site
11, Alexiensstreet
Brussels
1000
Belgium

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		04/08/2021	28/02/2023	Yes	No
Basic results		02/08/2021	02/08/2021	No	No
Participant information sheet			08/01/2021	No	Yes
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Additional files

ISRCTN15046229_PIS.docx: Uploaded 08/01/2021
ISRCTN15046229_BasicResults_02Aug21.pdf: Basic results

Editorial Notes

28/02/2023: Publication reference added.
02/08/2021: Basic results summary uploaded.
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.