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

Not Applicable

Completed

• Conditions: Tooth Extraction; Tooth Extraction Site Healing

• Registration Number: NCT06611865
• Lead Sponsor: Hamza Zia Ahmed

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.

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 Timeline

• Study Start: 2024-03-15
• Primary Completion: 2024-06-02
• Study Completion: 2024-06-17
• Status Verified: 2024-09
• Study First Submitted: 2024-09-15
• Study First Submitted QC: 2024-09-20
• Last Update Submitted: 2024-09-20
• Study First Posted: 2024-09-25
• Last Update Posted: 2024-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 535

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain during extraction procedure	For the duration of treatment (estimated within 1 hour)	Pain during extraction procedure on a scale of 0-10.
Unpleasantness of treatment	For the duration of treatment (estimated within 1 hour)	A rating of 0-10 for overall discomfort felt by the patient during the treatment.
Latency time of anesthesia (minutes)	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.	The onset of anesthesia after injection
Anesthetic effect	For the duration of treatment (estimated within 2 hours)	4 categories: Complete, sufficient, insufficient or no effect.
Amount of anesthetic solution (mL)	For the duration of treatment (estimated within 1 hour)	The average amount of anaesthetic solution injected per procedure.
Duration of treatment (minutes)	For the duration of treatment (estimated up to 1 to 2 hours)	Time in minutes taken from the injection to the complete extraction of tooth.
Duration of local numbness (minutes)	For the duration of treatment (estimated up to 1 to 2 hours)	Total duration of local numbness reported by the patient
Injection pain	Through the duration of injection (within a few seconds to 1 minute)	Rating of injection administration pain from 0-10.

Secondary Outcome Measures

Name	Time	Method
Incidence of Dry socket	From the complete extraction of tooth to 14 days after the extraction of tooth	Dry socket incidence reported by the patient int he recovery period of 14 days

Trial Locations

Locations (1)

Nishtar Institute of Dentistry; 🇵🇰 Multan, Punjab, Pakistan