Evaluation of Buffered Local Anesthesia in Dental Extraction.

University of Baghdad

Status and phase: Unknown; Phase 4

Conditions: Anesthesia, Local

Treatments: Drug: sodium bicarbonate 8.4%; Drug: 2%lidocaine with 1:80.000 epinphrine; Device: Mixing pen (onset buffering system)

Study type: Interventional

Funder types: Other

Identifiers

NCT04773236

206120

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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 .

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

100 participants in 2 patient groups, including a placebo group

Buffered Local anesthesia

Active Comparator group

Description:

Sodium bicarbonate with 2% lidocaine and 1:80.000 epinphrine

Treatment:

Drug: sodium bicarbonate 8.4%

Device: Mixing pen (onset buffering system)

Non Buffered Local anesthesia

Placebo Comparator group

Description:

2%lidocaine with 1:80.000 epinphrine.

Treatment:

Drug: 2%lidocaine with 1:80.000 epinphrine