Evaluation of Buffered Local Anesthesia in Dental Extraction.

Phase 4

• Conditions: Anesthesia, Local
• Interventions: Drug: sodium bicarbonate 8.4%; Device: Mixing pen (onset buffering system)

• Registration Number: NCT04773236
• Lead Sponsor: University of Baghdad

Brief 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.

Study Timeline

• Status Verified: 2021-02
• Study First Submitted: 2021-02-21
• Study Start: 2021-02-22
• Study First Submitted QC: 2021-02-25
• Last Update Submitted: 2021-02-25
• Study First Posted: 2021-02-26
• Last Update Posted: 2021-02-26
• Primary Completion: 2021-05-22
• Study Completion: 2021-08-22

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 .

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Buffered Local anesthesia	Mixing pen (onset buffering system)	Sodium bicarbonate with 2% lidocaine and 1:80.000 epinphrine
Buffered Local anesthesia	sodium bicarbonate 8.4%	Sodium bicarbonate with 2% lidocaine and 1:80.000 epinphrine

Primary Outcome Measures

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