Effectiveness of anesthesia in dental patients undergoing root canal treatment
| ISRCTN | ISRCTN60713096 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN60713096 |
- Submission date
- 02/02/2021
- Registration date
- 23/02/2021
- Last edited
- 23/02/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English Summary
Background and study aims
In mandibular back teeth when tissues are damaged it may result in a severely painful condition which is characterized by the presence of inflammation. Root canal treatment is a standard required procedure that is performed to eliminate the diseased condition in such teeth. Effective anesthesia is required to perform this procedure.
The aim of the study is to compare the effectiveness of two types of anesthesia to make the lower inflamed back teeth numb properly to complete the root canal treatment without pain.
Who can participate?
Adult patients presenting with pain because of irreversibly damaged pulpal tissues in their mandibular back teeth will participate in this study.
What does the study involve?
The study involves the injection of two types of anesthesia to compare their effectiveness.
What are the possible benefits and risks of participating?
None
Where is the study run from?
Qassim University (Saudi Arabia)
When is the study starting and how long is it expected to run for?
December 2019 to February 2023
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
1. Thonayan Abdullah Alodhaib, 361108742@qudent.org
2. Dr. Atif Agwan, m.abdulsaleem@qu.edu.sa
3. Dr. Muhammad Zubair Ahmad, m.muhammad@qu.edu.sa
Contact information
Public
Arras
Arras
52719
Saudi Arabia
 ORCID ID |
0000-0003-3018-7032 |
|---|---|
| Phone | +966 0559785542 |
| 361108742@qudent.org |
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 | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific title | Efficacy of 4% articaine versus 2% lidocaine as supplemental infiltration for mandibular molars with irreversible pulpitis |
| Study hypothesis | There is a difference between the efficacy of 4% articaine and 2% lidocaine for supplemental buccal infiltration in mandibular molars with Irreversible pulpitis after a failed inferior alveolar nerve block. |
| Ethics approval(s) | Approved 10/12/2019, Dental Ethics Committee of Alrass Dental College of Qassim University of Saudi Arabia (Alrass Dental College, 11 King Abdulaziz Street, Al Rass, Saudi Arabia; +966 163800050 Ext. 10685; rass.ethical@qudent.org), ref: DRC/13M/4-20 |
| Condition | Control of pain in symptomatic patients undergoing root canal treatment for mandibular molars with irreversible pulpitis |
| Intervention | We shall divide the patients into two groups after a standard inferior alveolar nerve block (IANB) anesthesia fails, one group will receive 2% Lidocaine buccal infiltration and the other group will receive 4% Articaine by a blinded operator. Masking will be done by covering the anesthesia cartridges using aluminium foils. The assignment will be done using computer generated numbers. At none of these levels, the principal investigator will be involved. This will eliminate operator related bias. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 4% articaine, 2% lidocaine with 1:100000 epinephrine |
| Primary outcome measure | Pain measured using a visual analogue scale (VAS) after 5 minutes of anesthesia |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 10/12/2019 |
| Overall study end date | 01/02/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 50 |
| Participant inclusion criteria | Symptomatic adult patients having mandibular first and/ or second molar tooth diagnosed with acute irreversible pulpitis. |
| Participant exclusion criteria | 1. Patients taking antibiotic 2. Medically compromised 3. Effective inferior alveolar nerve block 4. Patients with immature root apex 5. Non-restorable teeth 6. Patient refused to sign the inform consent 7. Pregnant patient 8. Patient with history of allergy from any of the contents of anesthesia |
| Recruitment start date | 17/01/2021 |
| Recruitment end date | 01/02/2023 |
Locations
Countries of recruitment
- Saudi Arabia
Study participating centre
Al Rass
52719
Saudi Arabia
Sponsor information
University/education
Al Rass Dental College
Secretary Dental Research Centre (DRC) and Ethical Approval Committee
11 King Abdulaziz Street
Al Rass
51921
Saudi Arabia
| Phone | +966 163800050 Ext. 10685 |
|---|---|
| rass.ethical@qudent.org | |
| Website | http://www.qu.edu.sa/Pages/Home.aspx |
"ROR" |
https://ror.org/01wsfe280 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/02/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | The results of this study will be disseminated by submitting in relevant dentistry journal and by presentations at local and international scientific conferences. |
| IPD sharing plan | All data generated or analysed during this study will be included in the subsequent results publication |
Editorial Notes
23/02/2021: Internal review.
08/02/2021: Trial’s existence confirmed by Dental Ethics Committee of Alrass Dental College of Qassim university of Saudi Arabia.
