Back to resultsTwo Approaches in Enhancing the Efficacy of Inferior Alveolar Nerve Block During Treatment of Mandibular First Permanent Molars With Symptomatic Irreversible Pulpitis
Primary Purpose
Pain, Procedural
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Cryotherapy
Buccal local anesthetic infiltration using articaine 4% 1:100000 epinephrine
Sponsored by
About this trial
This is an interventional supportive care trial for Pain, Procedural
Eligibility Criteria
Inclusion Criteria:
- Patients aged above 18 years
- Presence of at least one mandibular first permanent molar, with signs and symptoms of irreversible pulpititis
Exclusion Criteria:
- Participants with a history of taking medications that could interfere with the action of the anaesthetic solutions
- Presence of paresthesia
- Presence of psychological problems
- Taking analgesics or other medications that would alter the inflammatory response of the pulp or provide analgesia 12 h pre-operatively
Sites / Locations
- Minia UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Cryotherapy
IANB plus buccal infiltration local anesthesia
IANB
Arm Description
Outcomes
Primary Outcome Measures
Pain assessment
verbal rating scale (VRS) withh the following scores: Score 0: no pain, Score 1: mild pain, Score 2: moderate pain, and Score 3: severe pain.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05427903
Brief Title
Two Approaches in Enhancing the Efficacy of Inferior Alveolar Nerve Block During Treatment of Mandibular First Permanent Molars With Symptomatic Irreversible Pulpitis
Official Title
Evaluation of Two Approaches in Enhancing the Efficacy of Inferior Alveolar Nerve Block During Treatment of Mandibular First Permanent Molars With Symptomatic Irreversible Pulpitis: A Randomized Parallel Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 4, 2022 (Actual)
Primary Completion Date
June 18, 2022 (Anticipated)
Study Completion Date
July 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Minia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The study is designed as a randomized parallel controlled trial with three groups. Participants aged above 18 years with the first permanent molars with symptomatic signs of irreversible pulpitis will be randomly assigned into 3 groups. The first group (experimental group) will be injected with 4% articaine 1:100.000 epinephrine (inferior alveolar nerve block) will be anesthetized using 4% articaine 1:100.000 plus cryotherapy application, and the second group (experimental group) will be anaesthetised with IANB plus buccal infiltration. For the third group (control group), the mandibular molars will be anaesthetized using epinephrine using the inferior alveolar nerve block.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Procedural
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cryotherapy
Arm Type
Experimental
Arm Title
IANB plus buccal infiltration local anesthesia
Arm Type
Experimental
Arm Title
IANB
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Cryotherapy
Intervention Description
Ice packs application for 5 minutes after IANB injection
Intervention Type
Procedure
Intervention Name(s)
Buccal local anesthetic infiltration using articaine 4% 1:100000 epinephrine
Intervention Description
Buccal infiltration after IANB
Primary Outcome Measure Information:
Title
Pain assessment
Description
verbal rating scale (VRS) withh the following scores: Score 0: no pain, Score 1: mild pain, Score 2: moderate pain, and Score 3: severe pain.
Time Frame
up to 24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients aged above 18 years
Presence of at least one mandibular first permanent molar, with signs and symptoms of irreversible pulpititis
Exclusion Criteria:
Participants with a history of taking medications that could interfere with the action of the anaesthetic solutions
Presence of paresthesia
Presence of psychological problems
Taking analgesics or other medications that would alter the inflammatory response of the pulp or provide analgesia 12 h pre-operatively
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmad Elheeny, PhD
Phone
00201064257135
Email
ahmedelheeny@mu.edu.eg
Facility Information:
Facility Name
Minia University
City
Minya
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Omar Ahmed
Email
EG135.30708112400351@nies-edu.org
12. IPD Sharing Statement
Learn more about this trial
Two Approaches in Enhancing the Efficacy of Inferior Alveolar Nerve Block During Treatment of Mandibular First Permanent Molars With Symptomatic Irreversible Pulpitis
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