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

NCT06611865 | Completed

• 1 other identifier: 642/NID
• Study Type: interventional
• Target: 535
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Tooth Extraction; Tooth Extraction Site Healing

Keywords

Intraligamentary Anaesthesia; Inferior Alveolar Nerve Block; Tooth Extraction; Dry Socket

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (1)

• Incidence of Dry socket

  From the complete extraction of tooth to 14 days after the extraction of tooth

Study Arms (3)

Split-mouth group

ACTIVE COMPARATOR

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; Procedure: Inferior alveolar nerve block

Group 2 ILA

ACTIVE COMPARATOR

The patients in group 2, with unilateral extractions, that were only administered Intraligamentary anaesthesia.

Procedure: Intraligamentary anaesthesia

Group 2 IANB

ACTIVE COMPARATOR

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

Interventions

Intraligamentary anaesthesia PROCEDURE

Injection of anesthetic solution into the intraligamentary space along the long axis of a tooth root using a pressure syringe.

Group 2 ILA; Split-mouth group

Inferior alveolar nerve block PROCEDURE

Anaesthetic injection into the pterygomandibular space to block the Inferior alveolar nerve at the mandibular foramen point.

Group 2 IANB; Split-mouth group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• For patients: pregnancy, immunological compromise, systemic conditions requiring special considerations and non-compliance.

Sponsors & Collaborators

• Hamza Zia Ahmed: lead

Study Sites (1)

Nishtar Institute of Dentistry

Multan, Punjab Province, 60000, Pakistan

Location

MeSH Terms

Conditions

Dry Socket

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Officials

• Amjad Bari, MDS

  Nishtar Medical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A split-mouth group was included with 70 teeth extracted from 35 patients. In such cases, involving bilaterally indicated teeth, ILA and IANB were used on opposite sides, but the second tooth was anesthetized only after the first extraction had completed and had been recorded. The second group had 500 patients with unilateral extractions. ILA was compared with IANB in each group separately, and the results in group I were then compared descriptively with those in group II.

Study Record Dates

• First Submitted: September 15, 2024
• First Posted: September 25, 2024
• Study Start: March 15, 2024
• Primary Completion: June 2, 2024
• Study Completion: June 17, 2024
• Last Updated: September 25, 2024

Record last verified: 2024-09

Locations

PA (1)