Intraligamental Local Anesthesia Versus Infiltration Technique for Extraction of Grade II Mobility Maxillary Molars

• Sponsor: Minia University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05875350
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Actual Duration (Months): 1.5
• Patients Per Site Per Month: 40.6

Study Details

Study Description

Brief Summary

The study aims to assess the use of intraligamental local anesthetic injection compared to buccal infiltration for extraction of maxillary molars suffering grade II mobility in terms of pain control and extraction duration.

Condition or Disease	Intervention/Treatment	Phase
Anesthesia, Local	Procedure: Intraligamental local anesthetic injection	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Efficacy of Low Dose Intraligamental Local Anesthesia as an Alternative for Infiltration Technique for Extraction of Grade II Mobility Maxillary Molars: Double Blind Randomized Clinical Trial
• Actual Study Start Date: Mar 1, 2023
• Actual Primary Completion Date: Mar 30, 2023
• Actual Study Completion Date: Apr 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intraligamental local anesthetic injection	Procedure: Intraligamental local anesthetic injection; The intraligamental technique was administered using ligajet intraligamentary jet injector (Micro Mega Company) containing Articaine hydrochloride 4% with adrenaline 1:200000 (ArtPharma Dent, inc, Egypt)
No Intervention: Buccal infiltration local anesthetic injection

Outcome Measures

Primary Outcome Measures

1. Pain using visual analogue scale [immediately after injection]

   visual analogue scale (VAS) was used in which a pain score was recorded for each patient just after local anesthetic adminstration. The VAS score ranges from 0 (no pain) to 10 (extreme unbearable pain)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• healthy patients (class I category according to American society of anesthesiologists )

• Age range: 20 - 60 years of age,

• Either genders who are seeking dental extraction of maxillary molar teeth diagnosed with grade II mobility.

Exclusion Criteria:

• Patients with tooth that require trans osseous extraction

• Badly broken down coronal structure of the tooth to be extracted

• Patients with significant medical conditions

• Alcoh intake

• Patients on drugs that affect the central nervous systems

• Patients who reported the use of drugs that might interfere with pain sensitivity

• Pregnant or lactating women

• Patients who suffer from hypersensitivity to local anesthetics or non-steroidal anti-inflammatory drugs (NSAIDs).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Dentistry, Minia University	Minya		Egypt	2431412

Sponsors and Collaborators

• Minia University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Tarek Abdelbarry, Lecturer of Oral and Maxillofacial Surgery, Minia University
• ClinicalTrials.gov Identifier: NCT05875350
• Other Study ID Numbers: 716
• First Posted: May 25, 2023
• Last Update Posted: May 31, 2023
• Last Verified: May 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Anesthetics; Anesthetics, Local

Study Results

No Results Posted as of May 31, 2023