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
Study website
Contact information
Type
Scientific
Contact name
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/CTIS number
Nil known
IRAS number
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(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
Study design
Interventional randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study 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
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 study start date
09/10/2017
Overall study 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(s)
Patient
Age group
Child
Lower age limit
3 Years
Upper age limit
10 Years
Sex
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
Study 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
ROR
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
Intention to publish date
01/01/2021
Individual participant data (IPD) sharing plan
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.
IPD sharing plan summary
Available on request
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 08/01/2021 | No | Yes | ||
| Basic results | 02/08/2021 | 02/08/2021 | No | No | |
| Results article | 04/08/2021 | 28/02/2023 | Yes | No |
Additional files
- ISRCTN15046229_PIS.docx Uploaded 08/01/2021
- ISRCTN15046229_BasicResults_02Aug21.pdf