Comparison between a needle-free system (Comfort-In) and needle dental anaesthesia in adult volunteers
| ISRCTN | ISRCTN17400733 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17400733 |
| Secondary identifying numbers | 29/21.11.2018 |
- Submission date
- 22/11/2020
- Registration date
- 18/01/2021
- Last edited
- 30/04/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Anaesthesia is administered prior to a procedure to help dull pain or sedate a nervous or anxious patient. The most common form is local anaesthesia, meaning that it dulls pain in all or part of the mouth during dental work, but does not cause the patient to go to sleep.
The aim of the study is to compare dental anaesthesia injected with a needle to a needle-free device (Comfort-In) in adults.
Who can participate?
Healthy adult volunteers, aged 19-40 years, who had received dental anaesthesia in the past without dental phobia or other phobias.
What does the study involve?
One technique is applied on the right side and the other on the left side sequentially on the same day by the same dentist. Then several tests will be performed every few minutes in order to check which technique is more effective. During the procedure, participants will be asked several questions to make sure that the techniques are well tolerated. At the end of the session, at 24 hours and 7 days, all participants are asked to report any side-effects or complications and which of the two techniques they prefer.
What are the possible benefits and risks of participating?
There are no direct benefits for participants, but their contribution to research is valuable. There are no risks apart from those associated with dental anaesthesia.
Where is the study run from?
Dental School of the Aristotle University of Thessaloniki (Greece)
When is the study starting and how long is it excepted to run for?
September 2018 to July 2019
Who is funding the study?
The study received no funding. Comfort-In device and all the consumables were granted by Nordiga Medical Devices (http://www.nordiga.gr).
Who is the main contact?
Apostolina Theocharidou, koarap@dent.auth.gr
Contact information
Scientific
1 K. Alexandridi
Serres
62125
Greece
 ORCID ID |
0000-0002-0329-0520 |
|---|---|
| Phone | +302310999572 |
| koarap@dent.auth.gr |
Study information
| Study design | Interventional single-centre randomized controlled split-mouth study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Comparison of efficacy, acceptance and preference between Comfort-In local anaesthetic device and conventional infiltration technique in adult volunteers |
| Study acronym | JetorConv |
| Study objectives | Jet injection via Comfort-in device is superior to conventional local infiltration anaesthesia in terms of efficacy, acceptance and preference amongst adult volunteers. |
| Ethics approval(s) | Approved 28/11/2018, Ethics Committee of Dental School (Aristotle University of Thessaloniki School of Health Sciences School of Dentistry, Central Secretariat, A Lower ground, 54124, Thessaloniki, Greece; +302310999471; info@dent.auth.gr), ref: 29/21.11.2018 |
| Health condition(s) or problem(s) studied | Method of dental anaesthesia |
| Intervention | Upper premolars without any restorations or caries and with vital pulp tissue were chosen to be anaesthetized. One technique was applied on the right side whilst the other on the left side sequentially on the same day by the same operator. The anaesthetic solution comprised of 0.3ml of articaine 4% (1/200000 epinephrine) for both techniques. The quadrant and the order of administration were randomly assigned using an online randomization generator. Immediately after administration, at 3, 5, 10, 15, 20, 25 and 30 minutes, pulp vitality and soft tissue pain reaction tests were performed. At the end of the session, at 24 hours and 7 days, all participants were asked to report any adverse events and their preference. Blinding was not possible neither for the participants nor for the operator. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Comfort-in device |
| Primary outcome measure | Measured at 3, 5, 10, 15, 20, 25 and 30 minutes (unless otherwise noted): 1. Pulp vitality measured using electric pulp test (Pulppen DP2000 Digital, Dental Electronic) 2. Pulp sensitivity measured using the cold test (ethyl chloride spray) 3. Soft tissue pain measured using the reaction test (pinch via a pair of forceps) 4. Acceptance during the session and preference at the end of the session, at 24 hours and at 7 days were measured via questionnaires |
| Secondary outcome measures | 1. Length of subjective feeling of numbness was self-reported by volunteers at 24 hours 2. Adverse events were self-reported by volunteers at 24 hours and at 7 days |
| Overall study start date | 28/09/2018 |
| Completion date | 07/07/2019 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 63 |
| Total final enrolment | 63 |
| Key inclusion criteria | 1. Healthy adults, aged 19 - 40 years 2. History of previous dental anaesthesia 3. Present upper premolars with vital pulp tissue |
| Key exclusion criteria | 1. History of dental phobia or any other phobia 2. History of drug or substance abuse 3. Upper premolars with restorations/caries 4. Pregnant women |
| Date of first enrolment | 30/03/2019 |
| Date of final enrolment | 30/06/2019 |
Locations
Countries of recruitment
- Greece
Study participating centre
School of Dentistry
Thessaloniki
54124
Greece
Sponsor information
University/education
School of Health Sciences School of Dentistry
Central Secretariat
A Lower ground
Thessaloniki
54124
Greece
| Phone | +30 2310999471 |
|---|---|
| info@dent.auth.gr | |
| Website | https://www.auth.gr/en |
"ROR" |
https://ror.org/02j61yw88 |
Funders
Funder type
Other
No information available
No information available
Results and Publications
| Intention to publish date | 30/06/2021 |
|---|---|
| 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. Data will be provided in an excel file. They will be available for 10 years since the completion of the study. They will be shared with other researchers for systematics reviews and meta-analyses. Consent from participants was obtained. There is anonymisation of the data. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/04/2021 | 30/04/2021 | Yes | No |
Editorial Notes
30/04/2021: Publication reference added.
24/11/2020: Trial’s existence confirmed by Aristotle University of Thessaloniki School of Health Sciences School of Dentistry.
