Evaluation of Buffered Local Anesthesia in Dental Extraction.

NCT04773236 | Unknown Phase 4 FDA Device

• 1 other identifier: 206120
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Anesthesia, Local

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Buffered Local anesthesia

ACTIVE COMPARATOR

Sodium bicarbonate with 2% lidocaine and 1:80.000 epinphrine

Drug: sodium bicarbonate 8.4%; Device: Mixing pen (onset buffering system)

Non Buffered Local anesthesia

PLACEBO COMPARATOR

2%lidocaine with 1:80.000 epinphrine.

Drug: 2%lidocaine with 1:80.000 epinphrine

Interventions

sodium bicarbonate 8.4% DRUG

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

Buffered Local anesthesia

2%lidocaine with 1:80.000 epinphrine DRUG

injection

Non Buffered Local anesthesia

Mixing pen (onset buffering system) DEVICE

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

Buffered Local anesthesia

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Give written, informed consent (both the subject and the legal guardian).
• Be 18-65 years of age. 3.Be able to comprehend the visual analog scale (instructions given to ascertain this).
• Be able to comprehend the verbal rating scale (instructions given to ascertain this).
• upper premolars and molars extraction.

You may not qualify if:

• Patient under 18 years.
• pregnant women.
• 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 .

Sponsors & Collaborators

• University of Baghdad: lead

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 21, 2021
• First Posted: February 26, 2021
• Study Start: February 22, 2021
• Primary Completion: May 22, 2021
• Study Completion: August 22, 2021
• Last Updated: February 26, 2021

Record last verified: 2021-02