Efficacy of intraligamentary anaesthetic injection in mandibular premolars/incisors extraction

ISRCTN	ISRCTN83272316
DOI	https://doi.org/10.1186/ISRCTN83272316
Secondary identifying numbers	EA/6015/2018

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

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

Mrs Suzan Salem
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
Email	dr.suzan.salem@qudent.org

Study information

Study design	Prospective randomized comparative clinical trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Dental clinic, University/medical school/dental school
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a 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 hypothesis	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
Condition	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
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	3% mepivacaine
Primary outcome measure	Pain experienced during injection measured using the Modified Dental Anxiety Scale (MDAS) questionnaire and visual analog scales (VAS)
Secondary outcome measures	Pain experienced during extraction measured using the Modified Dental Anxiety Scale (MDAS) questionnaire and visual analog scales (VAS)
Overall study start date	11/11/2018
Overall study end date	01/06/2019

Eligibility

Participant type(s)	Patient
Age group	Mixed
Sex	Both
Target number of participants	100
Total final enrolment	100
Participant 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
Participant 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
Recruitment start date	01/01/2019
Recruitment end date	01/06/2019

Locations

Countries of recruitment

Saudi Arabia

Study participating centre

Qassim University

College of Dentistry
King AbdulAziz Road Mulaida
Buraidah
51452
Saudi Arabia

Sponsor information

Qassim University
University/education

College of Dentistry
King Abdulaziz Street
Mullaydah
P.O. 6700
Buraydah
51452
Saudi Arabia

Phone	+966 163011111
Email	info@qu.edu.sa
Website	http://www.qu.edu.sa/Pages/Home.aspx
"ROR"	https://ror.org/01wsfe280

Funders

Funder type

Other

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date	01/03/2023
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Published as a supplement to the results publication
Publication and dissemination plan	Planned for publication in highly impacted peer-reviewed journal "BMC Oral Health"
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

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.