Evaluation of Buffered Local Anesthesia in Dental Extraction.

Anesthesia, Local Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04773236
• Other study ID #: 206120
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: February 22, 2021
• Est. completion date: August 22, 2021

Study information

• Verified date: February 2021
• Source: University of Baghdad
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: August 22, 2021
• Est. primary completion date: May 22, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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 .

Related Conditions & MeSH terms

• Anesthesia, Local

Intervention

Drug:
• sodium bicarbonate 8.4%
mixing the sodium bicarbonate with 2%lidocaine and 1:80.000 epinphrine using mixing pen (onset buffering system)
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Baghdad

Outcome

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