Buccal Infiltration of Different Volumes of Articaine for Extraction.

NCT06630819 | Recruiting DMC

• 1 other identifier: 608/45/14624
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 2

Brief Summary

This study compares the effectiveness of two different volumes of buccal infiltration of Articaine for the extraction of mandibular posterior teeth. One group receives buccal infiltration of 1.8 ml of 4% Articaine and the other group receives buccal infiltration of 3.6 ml of 4% Articaine.

Conditions

Buccal Infiltration; Articaine; Anesthesia

Keywords

Buccal infiltration; Articaine

Outcome Measures

Primary Outcomes (3)

• Intensity of pain

  VAS scale is a validated scale measuring pain with possible score range from 0 (no pain) to 100 (severe pain).

  From reflection of mucoperiosteum till delivery of tooth out of socket.

• Time of onset of anesthesia

  It will be assessed by probing buccal and lingual soft tissue using a dental explorer every 2 minutes after infiltration using a standard digital stop clock.

  upto 10 minutes

• Presence or absence of pain

  A 100 mm Numerical rating scale assessing intraoperative pain. Possible score ranges from 0 (no pain) to 100 (worst possible pain).

  From reflection of mucoperiosteum till delivery of tooth out of socket.

Study Arms (2)

Group A

EXPERIMENTAL

Buccal infiltration of 3.6 ml of 4% Articaine

Other: 3.6 ml of 4% Articaine

Group B

ACTIVE COMPARATOR

Buccal infiltration of 1.8 ml of 4% Articaine

Other: 1.8 ml of 4% Articaine

Interventions

1.8 ml of 4% Articaine OTHER

Buccal infiltration of 1.8 ml of 4% Articaine

Group B

3.6 ml of 4% Articaine OTHER

Buccal infiltration of 3.6 ml of 4% Articaine.

Group A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All healthy patients (ASA I) or patients with mild systemic disease with no functional limitations (ASA II)
• Patients aged ≥ 18 years of age.
• Patients requiring extraction of mandibular posterior teeth including grossly decayed tooth, grade I mobile tooth, root stumps and indicated for therapeutic reasons.
• Patients not allergic to the drugs or anesthetic agents used in the surgery.

You may not qualify if:

• Acute infection at the extraction site.
• Patients indicated for surgical extraction of teeth.
• Patients already taking medications affecting pain assessment.
• Pregnant patients.

Sponsors & Collaborators

• Qassim University: lead

Study Sites (2)

Qassim University

Buraidah, Al Qassim, 52719, Saudi Arabia

NOT YET RECRUITING

College of Dentistry, Qassim University

Buraidah, 52385, Saudi Arabia

RECRUITING

MeSH Terms

Interventions

Carticaine

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Muhammad Atif S Agwan

CONTACT

966541651713; m.abdulsaleem@qu.edu.sa

Abdul K Azad

CONTACT

00966594914343; a.azad@qu.edu.sa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 24, 2024
• First Posted: October 8, 2024
• Study Start: November 24, 2024
• Primary Completion: May 2, 2026
• Study Completion: May 2, 2026
• Last Updated: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 1 year
• Access Criteria: Study protocol will be provided only if requested through proper channel with proper justification.

Locations

SA (2)