Efficacy of intraligamentary anaesthetic injection in mandibular premolars/incisors extraction

• Register: ISRCTN
• Last refreshed on: 10 February 2025
• Main ID: ISRCTN83272316
• Date of registration: 27/01/2023
• Prospective Registration: No
• Primary sponsor: Qassim University
• Public title: Efficacy of intraligamentary anaesthetic injection in mandibular premolars/incisors extraction
• Scientific title: Anesthetic efficacy of intraligamentary injection compared to incisive nerve block using 3% mepivacaine in mandibular premolars/incisors extraction: a randomized clinical trial
• Date of first enrolment: 01/01/2019
• Target sample size: 100
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN83272316
• Study type: Interventional
• Study design: Prospective randomized comparative clinical trial (Treatment)
• Phase: Not Applicable

Countries of recruitment

Saudi Arabia

Contacts

• Name: Suzan Salem

Key inclusion & exclusion criteria

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
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

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Pain during mandibular exodontia
Oral Health

Intervention(s)

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.

Primary Outcome(s)

Pain experienced during injection measured using the Modified Dental Anxiety Scale (MDAS) questionnaire and visual analog scales (VAS)

Secondary Outcome(s)

Pain experienced during extraction measured using the Modified Dental Anxiety Scale (MDAS) questionnaire and visual analog scales (VAS)

Secondary ID(s)

EA/6015/2018

Nil known

Source(s) of Monetary Support

Investigator initiated and funded

Ethics review

Status:
Approval date:
Contact:

Old ethics approval format; 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; [phone]; [e-mail]), ref: EA/6015/2018

Results

• Results available: Yes
• Date Completed: 01/06/2019