- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07597408
A Comparsion Between Articaine Hydrochloride and Buffered Lidocaine Hydrochloride in the Context of Maxillary Permanent Teeth Extraction Using the Buccal Infiltration Technique Only(Clinical Study).
palatal anesthesia remains one of the greatest fears of patients as well as being painful for the patient and bothersome for the dentist .Research is still ongoing to find the best anesthetic agent that achieves the highest success rate of anesthesia and pain control without the need for palatal injection.
2% Lidocaine with sodium bicarbonate the best agent that can achieve the highest success rate across all criteria when using the buccal infiltration technique without the need for palatal anesthesia? The importance of this research lies in finding the best agent that may eliminate the need for painful and annoying palatal injection, therapy alleviating many patient fears, achieving greater patient cooperation during dental procedures in the maxilla, and avoiding multiple palatal anesthesia failures.
This research aim to compare the anesthetic efficacy between 4% Articaine and 2% Lidocaine with sodium bicarbonate using the buccal infiltration technique without palatal anesthesia in the context of permanent maxillary first molar extraction, in terms of:
- Onset time of anesthesia
- Pain during injection
- Anesthetic efficacy
- Duration of anesthetic action The study will be conducted on a sample of patients attending the anesthesia and extraction clinics at the faculty of dentistry, University of Latakia, and the minor oral surgery and dental impaction clinic at Latakia University Hospital. The sample consists of 50 patients with symmetrical upper teeth that are worn down and require extraction.
Inclusion Criteria:
- Systemically healthy patients
- Patiens age between 18-60 years
- Patients with no allergy to amide local anesthetics
- Patients requiring extraction of fully erupted, permanent, single-root teeth Exclusion Criteria
1.Patients younger than 18 years 2.Patients who have taken any analgesic, sedative, antihistamine, anxiolytic, or beta-blocker medications (as the affect anesthetic efficacy assessment) 3.Patiens with sickle cell anemia 4.Patiens allergic to amid local anesthetics
The material and devices used in the study include:
Examination instruments: Forceps, mirror, probe. Local antiseptics: Sterile gauze- 0.12% chlorhexidine mouthwash.
Anesthesia instruments and materials:
- Topical anesthetic : Lidocaine 2% with vasoconstrictor epinephrine 1:80,000-cartridge volume 1.8 ml
- Local anesthetic: Articaine 4% with vasoconstrictor epinephrine 1:100,000-cartridge volume 1.8 ml
- Vial of sodium bicarbonate 8.4%- volume 10 ml , 1 ml insulin syringe, and 3 ml syringe
- Dental anesthetic syringe (Rowe type)-shoort needle, length 25 mm, diameter 27 gauge.
Technique
- Symmetrical anxiety in patients will be divided into two sessions, preferably at least one week apart.
- Before anesthesia, the heft-parker visual analog scale will be presented, and the patient will be taught how to choose the independent value according to degree of pain or discomfort they experience.
.In the first session, one of the two teeth will be selected using examples of intracanal reamers with internal engagement. The actual times corresponding to the internal statements of the slowly managed staff should be recorded without changing the lack of search. Then, time is calculated from the completion of the anesthetic solution deposition until the depth of anesthesia is confirmed using a sharp instrument with slight pressure at the tooth junction from the palatal side. The depth of anesthesia is assessed using the VAS project then the extraction is done.
If sufficient anesthetic depth is not achieved for each tooth, a palatal approach is added, and the case is considered excessive.
In the second session, 0.2 ml of mepivacaine is emptied and replace with 0.2ml of sodium bicarbonate. The dose is selected according to the depth of internal statements corresponding to the tooth to be treated. In the case of a normal plan, anesthesia is performed with a lack of search, and then time is calculated from the completion of the anesthetic solution deposition until the depth of anesthesia is confirmed using a sharp instrument with slight pressure at the tooth junction from the palatal side.
The depth of anesthesia is assessed using the VAS project then the extraction is done.
If sufficient anesthetic depth is not achieved for each tooth, a palatal approach is added, and the case considered excessive.
Study Overview
Status
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Latakia, Syria
- Latakia university
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Inclusion Criteria:
- Systemically healthy patients
- Patiens age between 18-60 years
- Patients with no allergy to amide local anesthetics
- Patients requiring extraction of fully erupted, permanent, single-root teeth Exclusion Criteria
- Patients younger than 18 years
- Patients who have taken any analgesic, sedative, antihistamine, anxiolytic, or beta-blocker medications (as the affect anesthetic efficacy assessment)
- Patients with sickle cell anemia
Patiens allergic to amid local anesthetics
Exclusion Criteria:
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: A Comparsion Between Articaine Hydrochloride and Buffered Lidocaine Hydrochloride in the Context of
|
The study will be conducted on a sample of patients attending the anesthesia and extraction clinics at the faculty of dentistry, University of Latakia, and the minor oral surgery and dental impaction clinic at Latakia University Hospital. The sample consists of 50 patients with symmetrical upper teeth that are worn down and require extraction. Inclusion Criteria:
1.Patients younger than 18 years 2.Patients who have taken any analgesic, sedative, antihistamine, anxiolytic, or beta-blocker medications (as the affect anesthetic efficacy assessment) 3.Patiens with sickle cell anemia 4.Patiens allergic to amid local anesthetics The material and devices used in the study include: Examination instruments: Forceps, mirror, probe. Local antiseptics: Sterile gauze- 0.12% chlo |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Visual Analogue Scale (VAS)
Time Frame: Time Frame: The follow-up begins from the start of anesthesia until its effect wears off after extraction. immediately after the intervention/procedure/surgery"
|
The Visual Analogue Scale (VAS) was used as the main scale to express the degree of pain. Description: Studied Variables 1.Pain at two surgical sites(the two fields) 2.Onset time of anesthetic effect 3.Anesthetic efficacy (by using a sharp needle inserted into the palatal gingiva to a certain depth) 4.Duration of anesthetic action(source: E-kholey 2016) |
Time Frame: The follow-up begins from the start of anesthesia until its effect wears off after extraction. immediately after the intervention/procedure/surgery"
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The Visual Analogue Scale (VAS) was used as the main scale to express the degree of pain.
Time Frame: The follow-up begins from the start of anesthesia until its effect wears off after extraction. immediately after the intervention/procedure/surgery"
|
Studied Variables
|
The follow-up begins from the start of anesthesia until its effect wears off after extraction. immediately after the intervention/procedure/surgery"
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Ahmad Ahmad, Professor, lattakia university
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Tishreen-U O,M Facial surgery
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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