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?
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?
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
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.
Approved 24/11/2017, Ethics committee of CHU Saint-Pierre (322, rue Haute, 1000, Brussels, Belgium; no telephone number provided; firstname.lastname@example.org), ref: B076201734515
Interventional randomized controlled trial
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
See additional files
Stress in children during dental care
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.
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
Overall trial end date
Reason abandoned (if study stopped)
Participant inclusion criteria
Patients aged 3 - 10 years, needing operative treatment on at least one primary molar
Target number of participants
Total final enrolment
Participant exclusion criteria
1. Children with infected or mobile decayed teeth
2. Outside the age range studied
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Pediatric Dentistry department Stomatology service César de Paepe site 11, Alexiensstreet
Investigator initiated and funded
Funding Body Type
Funding Body Subtype
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
Participant level data
Available on request
Basic results (scientific)
- ISRCTN15046229_PIS.docx Uploaded 08/01/2021