NCT07597408

Brief Summary

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:

  • 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
10mo left

Started Jul 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress53%
Jul 2025Feb 2027

Study Start

First participant enrolled

July 15, 2025

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 27, 2026

Completed
22 days until next milestone

First Posted

Study publicly available on registry

May 19, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2027

Expected
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2027

Last Updated

May 19, 2026

Status Verified

April 1, 2026

Enrollment Period

1.6 years

First QC Date

April 27, 2026

Last Update Submit

May 15, 2026

Conditions

Keywords

Articaine Hydrochloride, Lidocaine Hydrochloride, Buccal Infiltration ,Extraction ,

Outcome Measures

Primary Outcomes (2)

  • The Visual Analogue Scale (VAS)

    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"

  • The Visual Analogue Scale (VAS) was used as the main scale to express the degree of pain.

    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)

    The follow-up begins from the start of anesthesia until its effect wears off after extraction. immediately after the intervention/procedure/surgery"

Study Arms (1)

A Comparsion Between Articaine Hydrochloride and Buffered Lidocaine Hydrochloride in the Context of

EXPERIMENTAL
Procedure: A Comparsion Between Articaine Hydrochloride and Buffered Lidocaine Hydrochloride in the Context of Maxillary Permanent Teeth Extraction Using the Buccal Infiltration Technique

Interventions

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. Systemically healthy patients 2. Patiens age between 18-60 years 3. Patients with no allergy to amide local anesthetics 4. 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% chlo

A Comparsion Between Articaine Hydrochloride and Buffered Lidocaine Hydrochloride in the Context of

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Systemically healthy patients
  • Patiens age between 18-60 years
  • Patients with no allergy to amide local anesthetics

You may not qualify if:

  • <!-- -->
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Latakia university

Latakia, Syria

Location

Study Officials

  • Ahmad Ahmad, Professor

    lattakia university

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2026

First Posted

May 19, 2026

Study Start

July 15, 2025

Primary Completion (Estimated)

February 15, 2027

Study Completion (Estimated)

February 20, 2027

Last Updated

May 19, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations