Evaluation of Efficacy of Intraligamentary Anesthesia for Mandibular Molar Extractions

Evaluation of Efficacy of Intraligamentary Anesthesia by Two Different Techniques for Extraction of Mandibular Molars: A Randomized Controlled Trial

Dental extraction is the most common procedure undertaken in the department of Oral Surgery, inferior alveolar nerve block (IANB), till today, is the most commonly used local anaesthesia technique for extraction of lower posterior teeth. The anatomical complexity of this technique carries the risk of anaesthetic failures necessitating repeated needle penetrations and hence a painful experience for the patient. In addition, IANB technique, many times, becomes impossible to perform in fearful adult and paediatric patients, those with restricted mouth opening or intellectual disability. Certain coagulation defects are a contraindication to administration of IANB due to its depth of penetration into the tissues that may lead to fatal consequences in case of uncontrolled bleeding. Because of these shortcomings of IANB, there is always a need for alternative anaesthesia techniques that are less painful and carry lesser risks.

Anaesthetic injection into the Periodontal ligament space (space between tooth root surface and the bone forming the socket wall) as an alternative to IANB have been tested by many researchers with varying results. The expected advantages of this technique are reduced pain on injection, shorter duration of anaesthesia that prevents inadvertent lips and cheek biting after completion of the procedure. It is expected to be easier to perform in cases of restricted mouth opening and uncooperative patients due to any reason and carry lesser risk of bleeding within tissues.

The objective of our study is to evaluate the efficacy of Intra-ligamentary injection for posterior mandibular molar extraction as an alternative to inferior alveolar nerve block (IANB) so that it can be used in cases where IANB is either difficult to perform or not indicated.

Study Overview

• Status: Recruiting
• Conditions: Anesthesia, Local
• Intervention / Treatment: Procedure: Mandibular Molar Extraction Under Local Anesthesia

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Sind
    • Karachi, Sind, Pakistan
      • Recruiting
      • Hamdard University Dental Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 18 years and above
• Both genders.
• Teeth selection: Mandibular first and second molars needing extraction under local anaesthesia.
• Healthy patients or those with well controlled systemic disease.
• Patients consenting to participate in the study.

Exclusion criteria:

• Patients younger than 18 years.
• Mandibular third molars, acutely inflamed or infected first and second molars.
• Pregnant patients and those with poorly controlled systemic disease.
• Mentally handicapped patients.
• Patients not consenting to participate in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; Intraligamentary Injection by Jet Injector	Procedure: Mandibular Molar Extraction Under Local Anesthesia; Local Anaesthetic to be used: 2% Lidocaine in 1.8 ml cartridge (regularly used for dental anaesthesia regardless of the technique). Pain on injection and local anaesthesia success will be checked by using numeric pain rating scale (NPRS).
Experimental: Group B; Intraligamentary Injection by regular Dental Anesthesia Syringe	Procedure: Mandibular Molar Extraction Under Local Anesthesia; Local Anaesthetic to be used: 2% Lidocaine in 1.8 ml cartridge (regularly used for dental anaesthesia regardless of the technique). Pain on injection and local anaesthesia success will be checked by using numeric pain rating scale (NPRS).
Active Comparator: Group C; Inferior Alveolar Nerve Block	Procedure: Mandibular Molar Extraction Under Local Anesthesia; Local Anaesthetic to be used: 2% Lidocaine in 1.8 ml cartridge (regularly used for dental anaesthesia regardless of the technique). Pain on injection and local anaesthesia success will be checked by using numeric pain rating scale (NPRS).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain on injection	Pain on injection will be checked by using Numeric Pain Rating Scale (NPRS). NPRS is an 11 point scale in which 0: no pain, 1-3: mild pain, 4-7: moderate pain, 8-10: worst possible pain.	Immediately after local anesthesia administration regardless of the technique.
Local anesthesia success	Local anesthesia success will be checked by using Numeric Pain Rating Scale (NPRS). NPRS is an 11 point scale in which 0: no pain, 1-3: mild pain, 4-7: moderate pain, 8-10: worst possible pain.	1 minute after local anesthesia administration by intraligamentary injection regardless of the syringe used. 6 minutes after administration of Inferior Alveolar Nerve Block (IANB).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful completion of Extraction	Completion of extraction within 45 minutes, without changing the intervention. It will be measured on the following parameters: Local anesthesia success by NPRS after first administration of Intraligamentary injection (first primary outcome measure mentioned above).; Local anesthesia success by NPRS after second administration of intraligamentary injection (need to repeat the same technique).; Local anesthesia failure by Intraligamentary injection administered twice (as mentioned above) and need to change the technique to conventional Inferior Alveolar Nerve Block (IANB).	45 minutes from the first administration of local anesthesia injection.

Collaborators and Investigators

• Sponsor: Hamdard University

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2022
• Primary Completion (Anticipated): October 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: October 14, 2021
• First Submitted That Met QC Criteria: November 4, 2021
• First Posted (Actual): November 17, 2021

Study Record Updates

• Last Update Posted (Actual): March 1, 2023
• Last Update Submitted That Met QC Criteria: February 28, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: (21)3-4161310

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No