Evaluation of Buffered Local Anesthesia in Dental Extraction.

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Anesthesia, Local
• Intervention / Treatment: Drug: sodium bicarbonate 8.4%; Device: Mixing pen (onset buffering system); Drug: 2%lidocaine with 1:80.000 epinphrine

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Buffered Local anesthesia; Sodium bicarbonate with 2% lidocaine and 1:80.000 epinphrine	Drug: sodium bicarbonate 8.4%; mixing the sodium bicarbonate with 2%lidocaine and 1:80.000 epinphrine using mixing pen (onset buffering system); 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
Placebo Comparator: Non Buffered Local anesthesia; 2%lidocaine with 1:80.000 epinphrine.	Drug: 2%lidocaine with 1:80.000 epinphrine; injection

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Baghdad

Study record dates

Study Major Dates

• Study Start (Anticipated): February 22, 2021
• Primary Completion (Anticipated): May 22, 2021
• Study Completion (Anticipated): August 22, 2021

Study Registration Dates

• First Submitted: February 21, 2021
• First Submitted That Met QC Criteria: February 25, 2021
• First Posted (Actual): February 26, 2021

Study Record Updates

• Last Update Posted (Actual): February 26, 2021
• Last Update Submitted That Met QC Criteria: February 25, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: 206120

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes