Feasibility and advantages of using more comfortable combined injection technology in the treatment of deciduous molars
| ISRCTN | ISRCTN30082181 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN30082181 |
- Submission date
- 09/05/2025
- Registration date
- 12/05/2025
- Last edited
- 16/07/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
To find a local anesthesia has both comfortable and effective advantage in treatment of deep caries in mandibular deciduous molars in children.
Who can participate?
Children aged 4-6 years old (below 7) have deep caries in mandibular deciduous molars.
What does the study involve?
Two types of local anesthesia before the treatment of deep caries in mandibular deciduous molars: regular periodontal ligament injection and intraseptal injection combined with periodontal ligament injection.
What are the possible benefits and risks of participating?
Possible benefits: children received intraseptal injection combined with periodontal ligament injection have lower pain sensation during anesthesia; possible risks: children received intraseptal injection combined with periodontal ligament injection might still have pain sensation during treatment and need supplementary local anesthesia.
Where is the study run from?
Shenzhen Maternity and Child Healthcare Hospital (China)
When is the study starting and how long is it expected to run for?
May 2022 to June 2023
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Jin Sun, 631589163@qq.com
Contact information
Public, Scientific, Principal Investigator
Shenzhen Maternity and Child Healthcare Hospital
Shenzhen
518000
China
 ORCID ID |
0000-0002-5919-0406 |
|---|---|
| Phone | +86 15989022970 |
| 631589163@qq.com |
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 | No participant information sheet available |
| Scientific title | Feasibility and advantages of using intraseptal injection combined with periodontal ligament injection in the treatment of mandibular deciduous molars |
| Study objectives | The anesthetic effect of intraseptal injection combined with periodontal ligament injection and periodontal ligament injection alone were similar, moreover, intraseptal injection combined with periodontal ligament injection had lower pain sensation during the anesthesia. |
| Ethics approval(s) |
Approved 19/05/2022, The Research Ethics Committee of Shenzhen Maternity and Child Healthcare Hospital (Hongli Road, Futian District, Shenzhen, 518000, China; -; szfygcpll@163.com), ref: SFYLS[2022]025 |
| Health condition(s) or problem(s) studied | Deep caries in mandibular deciduous molars |
| Intervention | Control group: group PL: periodontal ligament injection Intervention group: group IS+PL: intraseptal injection combined with periodontal ligament injection The total duration of treatment for deep caries is approximately 0.5-1 hour. Randomization process: we toss a coin before meeting each child. The front of the coin represents the control group, and the back of the coin represents the intervention group. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Pain measured using the Wong-Baker FACE® Pain Rating Scale immediately after the anesthesia and immediately after the treatment |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 01/05/2022 |
| Completion date | 01/06/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 4 Years |
| Upper age limit | 6 Years |
| Sex | Both |
| Target number of participants | 60 |
| Total final enrolment | 60 |
| Key inclusion criteria | 1. Parents agreed to the experiment. 2. Children aged 4-6 years old (below 7). 3. Can communicate with pediatric dentist or nurse normally. 4. Had eaten food within 2 hours before treatment. 5. Mandibular deciduous molars erupted completely. 6. Had deep caries. 7. No obvious spontaneous, night, or occlusal pain or periapical periodontitis symptoms. 8. X-ray showed low density shadow close to pulp. 9. No obvious low density shadow at root tip. |
| Key exclusion criteria | 1. Parents refused the experiment. 2. Children were unable to cooperate. 3. Did not eat within 2 hours before treatment. 4. Had temporary or long-term systemic disease. 5. Allergic to anesthetics. 6. Oral mucosal diseases. 7. Wearing orthodontic appliances. 8. Mandibular deciduous molar did not erupt completely. 9. No deep caries. 10. Had obvious spontaneous, night, or occlusal pain or periapical periodontitis symptoms. 11. X-ray showed low density shadow at root tip or already had root canal therapy. |
| Date of first enrolment | 01/06/2022 |
| Date of final enrolment | 01/05/2023 |
Locations
Countries of recruitment
- China
Study participating centre
Shenzhen
518000
China
Sponsor information
Hospital/treatment centre
Hongli Road, Futian District
Shenzhen
518000
China
| szfygcpll@163.com | |
| Website | http://www.szmch.net.cn/ |
"ROR" |
https://ror.org/01me2d674 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/01/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Jin Sun 631589163@qq.com |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 03/07/2025 | 16/07/2025 | Yes | No |
Editorial Notes
16/07/2025: Publication reference added.
09/05/2025: Trial's existence confirmed by the Research Ethics Committee of Shenzhen Maternity and Child Healthcare Hospital.
