Skip to content

Evaluation of Buffered Local Anesthesia in Dental Extraction.

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04773236
Enrollment
100
Registered
2021-02-26
Start date
2021-02-22
Completion date
2021-08-22
Last updated
2021-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Local

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.

Interventions

DRUGsodium bicarbonate 8.4%

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

DRUG2%lidocaine with 1:80.000 epinphrine

injection

DEVICEMixing pen (onset buffering system)

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

Sponsors

University of Baghdad
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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 .

Design outcomes

Primary

MeasureTime frameDescription
Pain during InjectionImmediately after InjectionNumerical rating scale from 0-10 that (0) mean no pain and (10) worst pain
Onset of anesthesia30 seconds to 90 secondsprobing marginal gingiva
Effectiveness of anesthesiaduring procedurenumber of carpules used

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026