NCT07296926

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 15, 2024

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 26, 2025

Completed
26 days until next milestone

First Posted

Study publicly available on registry

December 22, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2026

Completed
Last Updated

January 6, 2026

Status Verified

December 1, 2025

Enrollment Period

1.5 years

First QC Date

November 26, 2025

Last Update Submit

December 30, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Pain during mucoperiosteal flap elevation

    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

    During mucoperiosteal flap elevation on the day of surgery

  • Pain During Bone Guttering

    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

    During bone guttering on the day of surgery.

Study Arms (2)

conventional nerve block injection

ACTIVE COMPARATOR

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

Procedure: Conventional Inferior Alveolar and Buccal Nerve Block

conventional inferior alveolar with distolingual infilterate injection

EXPERIMENTAL

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

Procedure: Distolingual Infiltration plus Conventional Nerve Block

Interventions

Standard inferior alveolar and long buccal nerve block for mandibular third molar extraction.

conventional nerve block injection

Distolingual infiltration (0.2 ml) administered in addition to conventional inferior alveolar during mandibular third molar extraction.

conventional inferior alveolar with distolingual infilterate injection

Eligibility Criteria

Age18 Years - 45 Years
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr Aimen Zafar

Islamabad, Pakistan

RECRUITING

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

dr aimen zafar Aimen zafar, bds

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
prinicpal investigator

Study Record Dates

First Submitted

November 26, 2025

First Posted

December 22, 2025

Study Start

August 15, 2024

Primary Completion

February 15, 2026

Study Completion

April 15, 2026

Last Updated

January 6, 2026

Record last verified: 2025-12

Locations