Evaluation of Buffered Local Anesthesia in Dental Extraction.

University of Baghdad100 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

100

Conditions

Anesthesia, Local

Interventions

sodium bicarbonate 8.4%DRUG

mixing the sodium bicarbonate with 2%lidocaine and 1:80.000 epinphrine using mixing pen (onset buffering system)

2%lidocaine with 1:80.000 epinphrineDRUG

injection

Mixing pen (onset buffering system)DEVICE

Premixing of the two solutions sodium bicarbonate and lidocaine with epinphrine before the local anesthesia adminstration to the patient

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Give written, informed consent (both the subject and the legal guardian). 2. Be 18-65 years of age. 3.Be able to comprehend the visual analog scale (instructions given to ascertain this). 4.Be able to comprehend the verbal rating scale (instructions given to ascertain this). 5.upper premolars and molars extraction. Exclusion Criteria: 1. Patient under 18 years. 2. pregnant women. 3. patient with uncontrolled systemic disease that are contraindicated for dental extraction. 4- patient taking medication that interfere with the assessment of local anesthetic such as narcotics and antidepressants .

Outcomes

Primary Outcomes

Pain during Injection

Numerical rating scale from 0-10 that (0) mean no pain and (10) worst pain

Time frame: Immediately after Injection

Onset of anesthesia

probing marginal gingiva

Time frame: 30 seconds to 90 seconds

Effectiveness of anesthesia

number of carpules used

Time frame: during procedure

Data from ClinicalTrials.gov

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