Comparison of Intraligamentary Anesthesia With the Inferior Alveolar Nerve Block for the Extraction of Mandibular Molars.

Cross-sectional Study Documenting the Relative Efficacy of Intraligamentary Anesthesia and the Inferior Alveolar Nerve Block for the Extraction of Posterior Mandibular Teeth.

Local anaesthesia or numbing is done before tooth extraction. This study compares two different methods of numbing molar teeth before extraction. It compares them on the basis of pain during the procedure and on discomfort after the procedure as well. It will help dentists better understand the benefits of the two techniques, and their usage case to case.

Study Overview

• Status: Completed
• Conditions: Tooth Extraction; Tooth Extraction Site Healing
• Intervention / Treatment: Procedure: Intraligamentary anaesthesia; Procedure: Inferior alveolar nerve block

Detailed Description

The study was designed as a randomized controlled trial. The purpose of this study was to examine the differences in efficacy of the intraligamentary anaesthetic technique and the inferior alveolar nerve block for mandibular posterior tooth extraction cases. Pain intensity, duration of anaesthesia, incidence of post-operative dry socket, success rates, onset of anaesthesia were examined. It was done in a split-mouth method so that two different techniques were used in the same patient, thus minimizing individual variations.

• Study Type: Interventional
• Enrollment (Actual): 535
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Multan, Punjab, Pakistan, 60000
      • Nishtar Institute of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients of both sexes who were more than 18 years of age; they had indications of non-surgical extraction of one or multiple mandibular posterior teeth.

Exclusion Criteria:

• For patients: pregnancy, immunological compromise, systemic conditions requiring special considerations and non-compliance.
• The exclusion criteria for individual teeth were: acutely infected teeth or any teeth with the instances of expression of pus through sinus tracts or the gingival sulcus were excluded. In case of multiple unilaterally indicated teeth that were to be extracted under IANB, only the tooth best fitting all criteria was considered for the study.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Split-mouth group; It includes bilaterally indicated teeth. ILA and IANB were used on opposite sides in the same person; the second tooth was anesthetized only after the first extraction had completed and had been recorded.	Procedure: Intraligamentary anaesthesia; Injection of anesthetic solution into the intraligamentary space along the long axis of a tooth root using a pressure syringe.; Procedure: Inferior alveolar nerve block; Anaesthetic injection into the pterygomandibular space to block the Inferior alveolar nerve at the mandibular foramen point.
Active Comparator: Group 2 ILA; The patients in group 2, with unilateral extractions, that were only administered Intraligamentary anaesthesia.	Procedure: Intraligamentary anaesthesia; Injection of anesthetic solution into the intraligamentary space along the long axis of a tooth root using a pressure syringe.
Active Comparator: Group 2 IANB; The patients in group 2, with unilateral extractions, that were only administered the Inferior Alveolar Nerve Block. In case of multiple unilaterally indicated teeth that were to be extracted under IANB, only the tooth best fitting all criteria was considered for the study.	Procedure: Inferior alveolar nerve block; Anaesthetic injection into the pterygomandibular space to block the Inferior alveolar nerve at the mandibular foramen point.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Injection pain	Rating of injection administration pain from 0-10.	Through the duration of injection (within a few seconds to 1 minute)
Pain during extraction procedure	Pain during extraction procedure on a scale of 0-10.	For the duration of treatment (estimated within 1 hour)
Unpleasantness of treatment	A rating of 0-10 for overall discomfort felt by the patient during the treatment.	For the duration of treatment (estimated within 1 hour)
Latency time of anesthesia (minutes)	The onset of anesthesia after injection	Anesthesia was tested with a dental probe on the marginal gingiva at: 1) immediately after the injection and 2) every 10 seconds (ILA) / every 30 seconds (IANB) until complete painlessness was achieved.
Anesthetic effect	4 categories: Complete, sufficient, insufficient or no effect.	For the duration of treatment (estimated within 2 hours)
Amount of anesthetic solution (mL)	The average amount of anaesthetic solution injected per procedure.	For the duration of treatment (estimated within 1 hour)
Duration of treatment (minutes)	Time in minutes taken from the injection to the complete extraction of tooth.	For the duration of treatment (estimated up to 1 to 2 hours)
Duration of local numbness (minutes)	Total duration of local numbness reported by the patient	For the duration of treatment (estimated up to 1 to 2 hours)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Dry socket	Dry socket incidence reported by the patient int he recovery period of 14 days	From the complete extraction of tooth to 14 days after the extraction of tooth

Collaborators and Investigators

• Sponsor: Hamza Zia Ahmed
• Investigators: Study Chair: Amjad Bari, MDS, Nishtar Institute of Dentistry

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2024
• Primary Completion (Actual): June 2, 2024
• Study Completion (Actual): June 17, 2024

Study Registration Dates

• First Submitted: September 15, 2024
• First Submitted That Met QC Criteria: September 20, 2024
• First Posted (Actual): September 25, 2024

Study Record Updates

• Last Update Posted (Actual): September 25, 2024
• Last Update Submitted That Met QC Criteria: September 20, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Dry Socket; Tooth Extraction; Inferior Alveolar Nerve Block; Intraligamentary Anaesthesia
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: 642/NID

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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