search
Back to results

Different Volumes of Articaine for Inferior Alveolar Nerve Block in Irreversible Pulpitis (IANB)

Primary Purpose

Drug Effect, Pulpitis - Irreversible

Status
Recruiting
Phase
Phase 2
Locations
Pakistan
Study Type
Interventional
Intervention
Articaine HCl 4 % / EPINEPHrine 1:100,000 in 1.8 mL Dental Cartridge
Sponsored by
Armed Forces Institute of Dentistry, Pakistan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Drug Effect

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Healthy patients, including age group 18-55 years old Mandibular first molar tooth with symptomatic irreversible pulpitis Normal periapical radiographic appearance Moderate pain on Heft-Parker VAS ( > 54 mm and < 114 mm ) Lingering pain or prolonged response to the cold testing (more than 10 seconds) Positive response to electric pulp testing Exclusion Criteria: Patients who have taken analgesic or anti-inflammatory drugs within 6 hours before treatment visit History of allergy to 4% articaine or epinephrine Patients with systemic diseases Pregnant or lactating patients Teeth with severe periodontal disease Teeth with periapical radiolucency Any type of medication that could potentially interact with the anesthetic solution (antihypertensives)

Sites / Locations

  • Armed Forces Institue Of DentistryRecruiting
  • Armed Forces Institute of DentistryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1.8 ml group

3.6 ml group

Arm Description

Participants in this group will be given 1 cartridge of articaine solution pre-operatively to endodontic treatment

Participants in this group will be given 2 cartridges of articaine solution pre-operatively to endodontic treatment

Outcomes

Primary Outcome Measures

Pain Control
Pain recordings on a self-report questionnaire using Heft-Parker Visual Analogue Scale. The scores are divided into 4 categories: No pain 0 mm Mild pain > 0 mm and ≤ 54 mm Moderate pain > 54 mm and < 114 mm Severe Pain ≥ 114 mm The success will be defined as the ability to undertake pulp access and canal instrumentation with no or mild pain (Heft-Parker visual analog scale [HP VAS] score <55 mm) whereas moderate or severe pain will considered as failure of anesthesia.

Secondary Outcome Measures

Full Information

First Posted
April 9, 2023
Last Updated
May 2, 2023
Sponsor
Armed Forces Institute of Dentistry, Pakistan
search

1. Study Identification

Unique Protocol Identification Number
NCT05840913
Brief Title
Different Volumes of Articaine for Inferior Alveolar Nerve Block in Irreversible Pulpitis
Acronym
IANB
Official Title
Comparison of Anaesthetic Effectiveness of Different Volumes of Articaine for Inferior Alveolar Nerve Block in Molar Teeth With Symptomatic Irreversible Pulpitis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 30, 2023 (Anticipated)
Primary Completion Date
October 30, 2023 (Anticipated)
Study Completion Date
October 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Armed Forces Institute of Dentistry, Pakistan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a randomized clinical trial comparing the anaesthetic efficacy of 1.8 and 3.6 mL of Articaine for inferior alveolar nerve block when treating mandibular molars with Irreversible Pulpitis
Detailed Description
An informed written consent of the patients will be obtained. (Annex-A). Demographic details (including name, age, gender, contact) will be obtained on data collection forms. (Annex-B). The principal investigator will perform the local anesthetic injection and the participants will be assigned to one of the groups. Group 1: 1.8 mL articaine Group 2: 3.6 mL articaine Before starting the treatment i.e. before administration of the anesthetic solution, each participant will receive an explanation regarding the Heft-Parker visual analog pain scale (VAS) and asked to rate their pain on a self-report questionnaire. A topical anesthetic gel (20% Benzocaine; Premier, Philadelphia, PA) will passively placed at the injection site with a cotton tip applicator for 1 minute before injection. A conventional IANB will administered using an aspirating syringe with a side-loading cartridge system (Dena Instruments; Forgeman Instruments Co, Sialkot, Pakistan) and a 27-G 31-mm needle (C-K ject; CK Dental, Kor-Kyungji-do, Korea). All injections will be given by one clinician in both groups. Group 2 participants will receive 2 cartridges of the anesthetic solution and group 1 will receive a cartridge of the anesthetic solution followed by a mock injection. The rest of the procedure will be performed by a second investigator. Ten minutes after injection, the participants will be asked whether they have lip numbness. Any patient without lip numbness at this stage will excluded from study. Fifteen minutes after the administration of the IANB, the teeth will be re-evaluated with electric pulp testing. On positive response, participants will be again asked to rate their pain using the HP VAS on the questionnaire. If higher than mild pain is reported, supplemental anesthesia (intraperiodontal ligament or intrapulpal injection) will be used to provide patient comfort throughout the treatment. Then teeth under study will be isolated with a rubber dam, and caries removed followed by the preparation of an endodontic access cavity. The participants will be informed to stop the practitioner at any stage of treatment if they feel more than mild pain by raising their hand. At the end of each stage of treatment (access cavity preparation, pulp chamber opening, root canal instrumentation), the practitioner will stop work and ask the participants to rate their pain if they do not raise their hand during treatment. The success will be defined as the ability to undertake pulp access and canal instrumentation with no or mild pain (Heft-Parker visual analog scale [HP VAS] score <55 mm) whereas moderate or severe pain will considered as failure of anesthesia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug Effect, Pulpitis - Irreversible

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
78 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1.8 ml group
Arm Type
Experimental
Arm Description
Participants in this group will be given 1 cartridge of articaine solution pre-operatively to endodontic treatment
Arm Title
3.6 ml group
Arm Type
Experimental
Arm Description
Participants in this group will be given 2 cartridges of articaine solution pre-operatively to endodontic treatment
Intervention Type
Drug
Intervention Name(s)
Articaine HCl 4 % / EPINEPHrine 1:100,000 in 1.8 mL Dental Cartridge
Other Intervention Name(s)
Orabloc 4% Articaine 1:100,000 1.8 ml
Intervention Description
Local anesthetic injection for intra- operative pain control
Primary Outcome Measure Information:
Title
Pain Control
Description
Pain recordings on a self-report questionnaire using Heft-Parker Visual Analogue Scale. The scores are divided into 4 categories: No pain 0 mm Mild pain > 0 mm and ≤ 54 mm Moderate pain > 54 mm and < 114 mm Severe Pain ≥ 114 mm The success will be defined as the ability to undertake pulp access and canal instrumentation with no or mild pain (Heft-Parker visual analog scale [HP VAS] score <55 mm) whereas moderate or severe pain will considered as failure of anesthesia.
Time Frame
30 to 45 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy patients, including age group 18-55 years old Mandibular first molar tooth with symptomatic irreversible pulpitis Normal periapical radiographic appearance Moderate pain on Heft-Parker VAS ( > 54 mm and < 114 mm ) Lingering pain or prolonged response to the cold testing (more than 10 seconds) Positive response to electric pulp testing Exclusion Criteria: Patients who have taken analgesic or anti-inflammatory drugs within 6 hours before treatment visit History of allergy to 4% articaine or epinephrine Patients with systemic diseases Pregnant or lactating patients Teeth with severe periodontal disease Teeth with periapical radiolucency Any type of medication that could potentially interact with the anesthetic solution (antihypertensives)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kanza Zafar, BDS
Phone
00923337808809
Email
kanzazafar6@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Abdullah, BDS
Phone
00923365747574
Email
ahmedcmh6@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kanza Zafar, BDS
Organizational Affiliation
AFID
Official's Role
Principal Investigator
Facility Information:
Facility Name
Armed Forces Institue Of Dentistry
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
46000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kanza Zafar, BDS
Phone
00923337808809
Email
kanzazafar6@gmail.com
Facility Name
Armed Forces Institute of Dentistry
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
46000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kanza Zafar, BDS
Phone
00923337808809
Email
kanzazafar6@gmail.com
First Name & Middle Initial & Last Name & Degree
Ahmed Abdullah, BDS
Phone
00923365747574
Email
ahmedcmh6@gmail.com
First Name & Middle Initial & Last Name & Degree
Kanza Zafar, BDS

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Different Volumes of Articaine for Inferior Alveolar Nerve Block in Irreversible Pulpitis

We'll reach out to this number within 24 hrs