Evaluation of Buffered Local Anesthesia in Dental Extraction.

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Anesthesia, Local

Intervention / Treatment
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* Drug: sodium bicarbonate 8.4%
* Drug: 2%lidocaine with 1:80.000 epinphrine
* Device: Mixing pen (onset buffering system)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Give written, informed consent (both the subject and the legal guardian). 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: Patient under 18 years. pregnant women. 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 .

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Buffered Local anesthesia<br>Sodium bicarbonate with 2% lidocaine and 1:80.000 epinphrine | Drug: sodium bicarbonate 8.4%<br>* mixing the sodium bicarbonate with 2%lidocaine and 1:80.000 epinphrine using mixing pen (onset buffering system)<br>Device: Mixing pen (onset buffering system)<br>* Premixing of the two solutions sodium bicarbonate and lidocaine with epinphrine before the local anesthesia adminstration to the patient<br>|
| Placebo Comparator: Non Buffered Local anesthesia<br>2%lidocaine with 1:80.000 epinphrine. | Drug: 2%lidocaine with 1:80.000 epinphrine<br>* injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain during Injection | Numerical rating scale from 0-10 that (0) mean no pain and (10) worst pain | Immediately after Injection | 
| Onset of anesthesia | probing marginal gingiva | 30 seconds to 90 seconds | 
| Effectiveness of anesthesia | number of carpules used | during procedure |