The use of computerized anesthesia 'QuickSleeper 5' in children undergoing dental treatment
| ISRCTN | ISRCTN60155644 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN60155644 |
| Secondary identifying numbers | 3079 |
- Submission date
- 10/01/2022
- Registration date
- 12/01/2022
- Last edited
- 01/02/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English Summary
Background and study aims
Dental local anesthesia is one of the most challenging concepts in pediatric dentistry for many reasons
1. Anatomical considerations of children make it somewhat difficult to achieve a high success rate with block anesthesia,
2. Pain caused by the injection itself can be one of the most common causes of cooperation lost in children and
3. Local complications caused by the local anesthesia are unpleasant for both child and parents, especially lip biting.
For these reasons, computerized intraosseous anesthetic devices like QuickSleeper 5 started to become more widespread recently in order to counteract all of the shortcomings associated with block anesthesia. However, clinical studies that touch on computerized intraosseous anesthesia devices are almost poor.
This was the reason behind conducting this study. The present study will compare between QuickSleeper 5 anesthesia and inferior alveolar nerve block (IANB) in children. The aim of this study is to evaluate the effectiveness, pain caused and complications associated with QuickSleeper 5 and compare it with block anesthesia as there is uncertainty about which is better or if they may be equivalent.
Who can participate?
cooperative children aged between 6-9 years who need bilateral pulpotomy treatment of mandibular second primary molars.
What does the study involve?
Children who participate in this trial will be exposed to both types of anesthesia (QuickSleeper 5 and IANB). The primary outcome of the study will be the effectiveness of anesthesia, pain caused by the injection, and local complications caused. The secondary outcome will be parental satisfaction.
What are the possible benefits and risks of participating?
Benefits: children who will participate in this trial will be anesthetized by two types of anesthesia with the least possible pain. in addition, their lower second primary molars will be treated.
Risks: as all contraindicated children to both lidocaine and epinephrine will be excluded, there will be no risk of participating in this trial.
Where is the study run from?
Damascus University (Syria)
When is the study starting and how long is it expected to run from?
August 2021 to August 2022
Who is funding the study?
Damascus University (Syria)
Who is the main contact?
Dr. Muaaz Alkhouli
muaaz.alkhouli@outlook.com
Contact information
Principal Investigator
Faculty of Dental Medicine, 2nd floor, Pediatric Dentistry department
Mazzeh street
Damascus
-
Syria
 ORCID ID |
0000-0003-0220-3859 |
|---|---|
| Phone | +963 966133383 |
| muaaz.alkhouli@outlook.com |
Scientific
Faculty of Dental Medicine, 2nd floor, Pediatric Dentistry department
Mazzeh street
Damascus
-
Syria
| Phone | +963 966956853 |
|---|---|
| mdashash@yahoo.com |
Study information
| Study design | Interventional double-blinded split mouth randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific title | Evaluation of the effectiveness, pain, and complications of computerized intraosseous anesthesia in comparison to block anesthesia in children |
| Study hypothesis | 1. QuickSleeper 5 is more effective than block anesthesia in anesthetizing mandibular second primary molars. 2. QuickSleeper 5 causes less pain than block anesthesia while anesthetizing mandibular second primary molars. 3. QuickSleeper 5 causes fewer complications than block anesthesia after anesthetizing mandibular second primary molars. |
| Ethics approval(s) | Approved 13/09/2021, Ethics scientific committee at Damascus University (Mazzeh Street, Damascus, Syria; +963 9933490577; drsalloum74@hotmail.com ), ref: 3079 |
| Condition | Anesthetizing primary molars in children |
| Intervention | This study will compare two types of dental anesthesia in children; the intervention type will QuickSleeper 5 (QS) and the control one will be an active control with an inferior alveolar nerve block (IANB). The study will include 52 participants aged between 7-9 years and all of them need bilateral pulpotomy for primary mandibular second molars in order to perform the study in a split mouth design. All participants will be allocated equally into two groups; Group 1: starts the first session with QS and the second session with IANB and Group 2: starts the first session with IANB and the second session with QS. A random allocation list will be carried out by using the website: www.randomalist.com, all of the participants will be numbered from 1 - 52 in order to allocate them randomly into the two study groups. After that, each child will pull a closed envelope to determine with which side they will start (right or left). Half of the ampule (0.9 ml) of Lidocaine 2% with epinephrine 1:100,000 will be administered for each child in both types of anesthesia used (IANB and QS) in the QuickSleeper injection, the insertion point will be between the first and second primary molars under the periodontal papilla. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | QuickSleeper 5 (Dental hi tech, France) |
| Primary outcome measure | 1. The effectiveness of both techniques of anesthesia will be studied during the pulp treatment procedure 2. Pain caused by the anesthesia will be studied using both subjective method (Simplified Faces Pain Scale S-FPS) immediately after the injection and objective method ( Face – Legs – Activity – Cry – Consolability scale FLACC) during the injection 3. Local complications of anesthesia will be studied at baseline, 24h, 48h and 1 week |
| Secondary outcome measures | Parental satisfaction will be studied after 1 week measured using a bespoke questionnaire |
| Overall study start date | 13/08/2021 |
| Overall study end date | 13/08/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Years |
| Upper age limit | 9 Years |
| Sex | Both |
| Target number of participants | 52 children with two injections for each child |
| Participant inclusion criteria | 1. Healthy children who don't suffer from any systemic disease 2. Children aged between 6 - 9 years 3. Children who need bilateral pulpotomy for mandibular second primary molars 4. Cooperative children who are classified as definitely positive according to Frankel |
| Participant exclusion criteria | 1. The existence of any chronic or acute infection in the area of injection 2. Children who have taken any analgesics in the last two days before the anesthesia 3. Children who have allergy to amide type of anesthetic solutions. 4. Children who are contraindicated to lidocaine injection (who suffer from liver cirrhosis, hepatitis) 5. Children who are contraindicated to vasoconstrictors injection (who suffer from hypertension, myocardial infarction, angina pectoris) 6. Children who do not show cooperation during the procedure |
| Recruitment start date | 02/03/2022 |
| Recruitment end date | 07/07/2022 |
Locations
Countries of recruitment
- Syria
Study participating centre
Damascus
30621
Syria
Sponsor information
University/education
Mazzeh street
Damascus
30621
Syria
| Phone | +963 (11) 339 23223 |
|---|---|
| ap.srd@damascusuniversity.edu.sy | |
| Website | http://damasuniv.edu.sy/ |
"ROR" |
https://ror.org/03m098d13 |
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- University of Damascus, جَامِعَةُ دِمَشْقَ, DU
- Location
- Syria
Results and Publications
| Intention to publish date | 01/08/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository, Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The original data, along with the codebook and analysis scripts, will be stored in a non-publicly available repository. The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request (muaaz.alkhouli@outlook.com) |
Editorial Notes
01/02/2022: Internal review.
13/01/2022: Internal review.
12/01/2022: Trial's existence confirmed by Ethics scientific committee at Damascus University.
