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Clinical Trials/NCT07296926
NCT07296926RecruitingNot Applicable

Comparison of Efficacy of Distolingual Infiltration in Conjugation With Conventional Inferior Alveolar Nerve Block to Conventional Inferior Alveolar Nerve Block Alone for Extraction of Mandibular Third Molar

Watim Medical & Dental College1 site in 1 country120 target enrollmentStarted: August 15, 2024Last updated:
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
120
Locations
1
Primary Endpoint
Pain during mucoperiosteal flap elevation

Study Overview

Brief Summary

This randomized controlled trial will compare the effectiveness of adding distolingual infiltration to conventional inferior alveolar and buccal nerve blocks for mandibular third molar extraction. A total of 120 patients will be allocated into two groups. Pain during flap elevation and bone guttering will be assessed using the Visual Analogue Scale.

Detailed Description

Mandibular third molar extraction is a common oral and maxillofacial surgery procedure that requires profound local anesthesia. Despite conventional inferior alveolar, lingual and buccal nerve blocks, the distolingual gingiva may remain non-anesthetized due to accessory innervation via the mylohyoid and other nerves. Distolingual infiltration may improve anesthesia in this area.

This randomized controlled trial will enroll 120 patients requiring mandibular third molar extraction. Participants will be randomized into two groups: conventional inferior alveolar and buccal nerve block (Group A) and the same technique with additional distolingual infiltration (Group B). Pain during mucoperiosteal flap elevation and bone guttering will be recorded on a 0-10 Visual Analogue Scale. The primary objective is to determine whether distolingual infiltration improves pain control compared to the conventional technique.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 45 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Healthy individuals
  • Male and female
  • Age 18-45 years
  • Mandibular third molar impaction - all positions
  • Mandibular third molar impaction - all classes

Exclusion Criteria

  • ASA status III and above
  • Patients requiring multiple extractions in the same appointment
  • Allergy to lignocaine
  • Patients in whom adrenaline is contraindicated
  • Medically compromised individuals e.g. poorly controlled diabetes, hypertension

Arms & Interventions

conventional nerve block injection

Active Comparator

Inferior alveolar and buccal nerve block using 2% lignocaine with adrenaline (1:80,000) without distolingual infiltration.

Intervention: Conventional Inferior Alveolar and Buccal Nerve Block (Procedure)

conventional inferior alveolar with distolingual infilterate injection

Experimental

Inferior alveolar supplemented with distolingual infiltration using 2% lignocaine with adrenaline (1:80,000).

Intervention: Distolingual Infiltration plus Conventional Nerve Block (Procedure)

Outcomes

Primary Outcomes

Pain during mucoperiosteal flap elevation

Time Frame: During mucoperiosteal flap elevation on the day of surgery

Pain intensity experienced during flap elevation will be assessed using the Visual Analogue Scale (VAS). This is a 0-10 point numerical scale where participants indicate the pain level experienced at the time of flap elevation. Measurement Tool: Visual Analogue Scale (VAS) Scale: * Minimum score: 0 (no pain) * Maximum score: 10 (worst possible pain) * Directionality: Higher scores indicate worse pain

Pain During Bone Guttering

Time Frame: During bone guttering on the day of surgery.

Pain intensity during bone guttering will be recorded using the Visual Analogue Scale (VAS). Measurement Tool: Visual Analogue Scale (VAS) Scale: * Minimum: 0 (no pain) * Maximum: 10 (worst pain) * Higher scores = worse pain

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Watim Medical & Dental College
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

aimen zafar

prinicpal investigator

Watim Medical & Dental College

Study Sites (1)

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