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 |
| Secondary identifying numbers | B076201734515 |
- 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
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
Contact information
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 |
| Tania.Vanhee@ulb.be |
Study information
| Study design | Interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 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 |
| 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 |
Eligibility
| 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 inclusion criteria | Patients aged 3 - 10 years, needing operative treatment on at least one primary molar |
| 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
Stomatology service
César de Paepe site
11, Alexiensstreet
Brussels
1000
Belgium
Sponsor information
University/education
Faculté de Médecine
808 Route de Lennik
Brussels
1070
Belgium
| Phone | +32 (0)25556799 |
|---|---|
| admin.medecine@ulb.be | |
| Website | http://www.ulb.ac.be/ |
"ROR" |
https://ror.org/01r9htc13 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/01/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| 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? |
|---|---|---|---|---|---|
| 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
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.
