NCT04773236

Evaluation of Buffered Local Anesthesia in Dental Extraction.

Evaluation of Buffered Local Anesthesia in Dental Extraction: A Randomized Clinical Study.

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University of Baghdad · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

To compare pain during injection, onset of anesthesia and effectiveness of anesthesia using buffered versus non- buffered 2% lidocaine with 1:80,000 adrenaline in dental extraction.

Detailed description

The investigators will conduct a prospective, randomized, single-blinded study, the sample will include 100 patients (extraction) who need dental extraction of upper teeth (premolar and molar teeth). The predictor variable is the use of buffered 2% lidocaine with 1:80,000 adrenaline and non-buffered 2% lidocaine with 1:80,000 adrenaline. The patients will be randomly assigned into two groups of 50 patients each using Microsoft Excel 2016; the first group (study group) will undergo dental extraction after receiving buffered 2% lidocaine with 1:80,000 adrenaline, the second group (control group) will undergo dental extraction after receiving non-buffered 2% lidocaine with 1:80,000 adrenaline. The outcome variables include pain during injection, onset of anesthesia and effectiveness of anesthesia on buffered and non-buffered group.

Conditions

• Anesthesia, Local

Interventions

Type	Name	Description
DRUG	sodium bicarbonate 8.4%	mixing the sodium bicarbonate with 2%lidocaine and 1:80.000 epinphrine using mixing pen (onset buffering system)
DRUG	2%lidocaine with 1:80.000 epinphrine	injection
DEVICE	Mixing pen (onset buffering system)	Premixing of the two solutions sodium bicarbonate and lidocaine with epinphrine before the local anesthesia adminstration to the patient

Timeline

• Start date: 2021-02-22
• Primary completion: 2021-05-22
• Completion: 2021-08-22
• First posted: 2021-02-26
• Last updated: 2021-02-26

Regulatory

• FDA-regulated device study