Efficacy of intraligamentary anaesthetic injection in mandibular premolars/incisors extraction
| ISRCTN | ISRCTN83272316 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN83272316 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | EA/6015/2018 |
| Sponsor | Qassim University |
| Funder | Investigator initiated and funded |
- Submission date
- 27/01/2023
- Registration date
- 27/01/2023
- Last edited
- 28/01/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Pain control is the foundation of successful dental patient management. A good injection technique is essential for consistent anesthesia. There are different techniques for anesthesia. For the mandibular incisors and premolars (lower teeth), we can use the inferior alveolar nerve block (IANB) technique, but a number of disadvantages have been shown to be associated with this technique it is also the most frustrating with the highest percentage of failure even when properly administered. One of the alternative anesthetic techniques that can be used is the periodontal ligament (PDL) anesthetic technique (also referred to as the intraligamentary injection technique) and the incisive nerve block technique. The aim of this study is to determine which anesthetic technique is more effective at reducing pain during mandibular exodontia (removal of teeth).
Who can participate?
Patients aged from 20 to 60 years attending an outpatient dental clinic at Qassim University Saudi Arabia undergoing tooth extractions (mandibular premolars and incisors)
What does the study involve?
Participants were divided randomly into two groups. The first group is given an incisive block before extraction and the other group is given an intraligmentary injection. The pain during injection and extraction will be assessed in both groups.
What are the possible benefits and risks of participating?
The benefit is to reduce the need to give nerve blocks to reduce the pain experienced by the patient during local anesthesia injection and extraction. There is no risk in participating in this study
Where is the study run from?
College of Dentistry, Qassim University (Saudi Arabia)
When is the study starting and how long is it expected to run for?
November 2018 to June 2019
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Suzan Salem, dr.suzan.salem@qudent.org
Contact information
Principal investigator
College of Dentistry
Qassim University
King Abdulaziz Street
Mullaydah
P.O. 6700
Buraydah
51452
Saudi Arabia
 ORCID ID |
0000-0003-4393-6338 |
|---|---|
| Phone | +966 531017409 |
| dr.suzan.salem@qudent.org |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective randomized comparative clinical trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Anesthetic efficacy of intraligamentary injection compared to incisive nerve block using 3% mepivacaine in mandibular premolars/incisors extraction: a randomized clinical trial |
| Study objectives | The aim of the study is to compare the pain experienced during injection and extraction of mandibular premolars and incisors using the intraligamentary injection technique (ILI) and the incisive nerve block technique (INB) |
| Ethics approval(s) | Approved 10/12/2018, Qassim University College of Dentistry Dental Ethics Committee (Research Ethics Committee, Dental Research Center, Qassim University, 51452, P.O. 6700, Saudi Arabia; +966 (0)163801761; ethical.committee@qudent.org), ref: EA/6015/2018 |
| Health condition(s) or problem(s) studied | Pain during mandibular exodontia |
| Intervention | The randomisation process was two sealed envelopes with the two interventions and one of the dental auxiliaries was requested to deliver them to the participant and requested to choose one of them. Two local anesthetic techniques were used for the extraction of mandibular incisor/premolars For each technique, a standard 27-gauge short needle was used which was loaded with 3% mepivacaine. A topical anesthetic was applied at the site of injection. For patients receiving the ILT, the needle was directed parallel to the long axis of the tooth and inserted till the depth of the gingival sulcus on the mesial and distal aspects of the root, buccal and lingual side. A dose of 0.2 mL of LA was given over 30 seconds. For patients receiving INBT, the needle was directed on the mucobuccal fold just anterior to the mental foramen. The depth of penetration is 5 to 6 mm. A dose of 0.6 mL of LA (approximately one-third of a cartridge) solution was given over 30 seconds, and 0.3 ml LA solution was given as lingual infiltration. The patients were asked to assess the degree of pain during needle insertion using the pain assessment form while waiting for the anesthesia to take effect. The extraction was performed after the symptoms were evaluated. After the extraction, the patients were asked to assess the pain of the extraction using the same form. |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 3% mepivacaine |
| Primary outcome measure(s) |
Pain experienced during injection measured using the Modified Dental Anxiety Scale (MDAS) questionnaire and visual analog scales (VAS) |
| Key secondary outcome measure(s) |
Pain experienced during extraction measured using the Modified Dental Anxiety Scale (MDAS) questionnaire and visual analog scales (VAS) |
| Completion date | 01/06/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | All |
| Target sample size at registration | 100 |
| Total final enrolment | 100 |
| Key inclusion criteria | 1. Healthy patients 2. Exhibiting a full understanding of the given oral instructions 3. Caries or fractures in relation to mandibular premolars and incisors that were not restorable |
| Key exclusion criteria | 1. Patients with a malignant neoplasm, cardiac pacemaker, diabetes or epilepsy 2. Pregnancy 3. Presence of acute dentoalveolar infection, periodontally compromised teeth 4. Unwilling to participate in the study |
| Date of first enrolment | 01/01/2019 |
| Date of final enrolment | 01/06/2019 |
Locations
Countries of recruitment
- Saudi Arabia
Study participating centre
King AbdulAziz Road Mulaida
Buraidah
51452
Saudi Arabia
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Published as a supplement to the results publication |
| IPD sharing plan | The datasets generated during and/or analyzed during the current study will be published as a supplement to the results publication |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 17/01/2025 | 28/01/2025 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
28/01/2025: Publication reference added.
10/02/2023: The intention to publish date was changed from 01/02/2023 to 01/03/2023.
27/01/2023: Trial's existence confirmed by the Qassim University College of Dentistry Dental Ethics Committee.
