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Evaluation of Buffered Local Anesthesia in Dental Extraction.

NCT ID: NCT04773236

Last Updated: 2021-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-22

Study Completion Date

2021-08-22

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.

Conditions

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Anesthesia, Local

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Buffered Local anesthesia

Sodium bicarbonate with 2% lidocaine and 1:80.000 epinphrine

Group Type ACTIVE_COMPARATOR

sodium bicarbonate 8.4%

Intervention Type DRUG

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

Mixing pen (onset buffering system)

Intervention Type DEVICE

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

Non Buffered Local anesthesia

2%lidocaine with 1:80.000 epinphrine.

Group Type PLACEBO_COMPARATOR

2%lidocaine with 1:80.000 epinphrine

Intervention Type DRUG

injection

Interventions

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sodium bicarbonate 8.4%

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

Intervention Type DRUG

2%lidocaine with 1:80.000 epinphrine

injection

Intervention Type DRUG

Mixing pen (onset buffering system)

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

Intervention Type DEVICE

Eligibility Criteria

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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 .
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Baghdad

OTHER

Sponsor Role lead

Responsible Party

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Danny Benjamin

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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206120

Identifier Type: -

Identifier Source: org_study_id