- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07296926
Distolingual Infiltration Verses Conventional Nerve Block in Mandibular Third Molar Extraction
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
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: dr aimen zafar Aimen zafar, bds
- Phone Number: +923361056720
- Email: aimenali216@gmail.com
Study Locations
-
-
-
Islamabad, Pakistan
- Recruiting
- Dr Aimen Zafar
-
Contact:
- aimen zafar zafar masood, bds
- Phone Number: 00923361056720
- Email: aimenali216@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: conventional nerve block injection
Inferior alveolar and buccal nerve block using 2% lignocaine with adrenaline (1:80,000) without distolingual infiltration.
|
Standard inferior alveolar and long buccal nerve block for mandibular third molar extraction.
|
|
Experimental: conventional inferior alveolar with distolingual infilterate injection
Inferior alveolar supplemented with distolingual infiltration using 2% lignocaine with adrenaline (1:80,000).
|
Distolingual infiltration (0.2 ml) administered in addition to conventional inferior alveolar during mandibular third molar extraction.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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:
|
During mucoperiosteal flap elevation on the day of surgery
|
|
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:
|
During bone guttering on the day of surgery.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DSG-2023-335-4631-A
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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