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Anesthesia Techniques in Symptomatic Mandibular Molars With Irreversible Pulpitis

Primary Purpose

Anesthesia, Dental

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Inferior Alveolar Nerve Block Group
Intraligamentary Injection Group
Sponsored by
Cukurova University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anesthesia, Dental focused on measuring pain, irreversible pulpitis, intraligamentary injection, inferior alveolar nerve block

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Systemically healthy patients The absence of periapical pathology Not sensitive to articaine or epinephrine No facial paresthesia Not taking any analgesic drug 6 hours before treatment Not taking any medication that interferes with anesthesia, such as tricyclic antidepressants and beta-blockers The absence of pathosis in areas planned for injection Not pregnant The absence of pathologic periodontal pockets during probing Patients with a mandibular first molar tooth exhibiting symptomatic irreversible pulpitis Exclusion Criteria: -

Sites / Locations

  • Çukurova University, Faculty of Dentistry, Clinic of Endodontics

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Inferior Alveolar Nerve Block Group

Intraligamentary Injection Group

Arm Description

A standard Inferior Alveolar Nerve Block (IANB) injection with a conventional dental injector and a 27-G needle to achieve pulpal anesthesia in mandibular molar teeth.

An intraligamentary injection that performed with a special pressure injection syringe (Sopira Citoject, Kulzer, Hanau, Germany) and a 30-G needle.

Outcomes

Primary Outcome Measures

The success of anesthesia techniques
Heft-Parker visual analog scale (HPVAS) was used to evaluate the patient's subjective pain and convert it to quantitative values. The pain was classified as follows: 0, no pain as "1"; 1-54 mm, mild pain as "2"; 55-112 mm, moderate pain as "3"; and 114-170 mm, severe pain as "4". If the VAS value is 1 and 2, anesthesia is considered successful, if 3 and 4, anesthesia is considered unsuccessful. HPVAS-1 determines the VAS value of pain response to cold test. The VAS value of the pain response at the start of the treatment is HPVAS-2. The VAS value of the pain response on entering the pulp chamber HPVAS-3: The VAS value of the pain response during pulp extirpation was recorded as HPVAS-4.

Secondary Outcome Measures

Full Information

First Posted
April 20, 2023
Last Updated
May 3, 2023
Sponsor
Cukurova University
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1. Study Identification

Unique Protocol Identification Number
NCT05839093
Brief Title
Anesthesia Techniques in Symptomatic Mandibular Molars With Irreversible Pulpitis
Official Title
Evaluation of the Efficiency of Intraligamentary + Buccal Infiltration Anesthesia and Inferior Alveolar Nerve Block + Buccal Infiltration Anesthesia in Symptomatic Mandibular Molars With Irreversible Pulpitis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
December 21, 2021 (Actual)
Primary Completion Date
March 3, 2022 (Actual)
Study Completion Date
March 14, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cukurova 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 aim of this clinical study is to evaluate the success of buccal infiltration (BI) anesthesia + intraligamentary (ILI) anesthesia between inferior alveolar nerve block (IANB) anesthesia + buccal infiltration anesthesia in mandibular molar teeth with acute symptomatic irreversible pulpitis.The main questions it aims to answer are: Does the anesthesia techniques adequate to perform root canal treatment painlessly? Which technique achieved pulpal anesthesia? Participants were allocated in two groups according to the randomization blocks, with a total of 25 patients in each group. In IANB + BI anesthesia techniques, a total of approximately 2.8 ml of anesthetic solution, 1.8 ml + 1 ml, was applied, while for BI + ILI, a total of approximately 1.72 ml, 1 ml + 0.72 ml, was administered. Then, root canal treatment was performed. Researchers were compared the success of anesthesia techniques in different stages of root canal treatment.
Detailed Description
A total of 50 patients, aged between 18-65, who were diagnosed with symptomatic irreversible pulpitis of the mandibular molar tooth, were included in this study. The patients were allocated in two groups according to the randomization blocks, with a total of 25 patients in each group. In IANB + BI anesthesia techniques, a total of approximately 2.8 ml of anesthetic solution, 1.8 ml + 1 ml, was applied, while for BI + ILI, a total of approximately 1.72 ml, 1 ml + 0.72 ml, was administered. After the anesthesia, a rubber dam was placed on the associated tooth of the patient for root canal treatment, the endodontic access cavity was opened, and canal preparation procedures were started. The pain levels felt by the patients during the endodontic treatment stages (starting the treatment, opening the endodontic access cavity and pulp extirpation) were determined by Heft-Parker VAS (HP-VAS) scale. Anesthesia was considered successful in patients who felt no pain (HP-VAS ratio = 0) or mild pain (HP-VAS ratio ≤ 54) during the procedures.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia, Dental
Keywords
pain, irreversible pulpitis, intraligamentary injection, inferior alveolar nerve block

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
210 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Inferior Alveolar Nerve Block Group
Arm Type
Active Comparator
Arm Description
A standard Inferior Alveolar Nerve Block (IANB) injection with a conventional dental injector and a 27-G needle to achieve pulpal anesthesia in mandibular molar teeth.
Arm Title
Intraligamentary Injection Group
Arm Type
Experimental
Arm Description
An intraligamentary injection that performed with a special pressure injection syringe (Sopira Citoject, Kulzer, Hanau, Germany) and a 30-G needle.
Intervention Type
Device
Intervention Name(s)
Inferior Alveolar Nerve Block Group
Intervention Description
A standard IANB injection with a conventional dental injector and a 27-G needle. After determining the injection site and performing aspiration, 1.8 mL of solution was injected at a rate of 1 mL/min to block the inferior alveolar nerve. After achieving lip anesthesia, infiltration was performed at the buccal side of the affected tooth with 0.5 mL using a normal syringe and a 27-G needle. The needle insertion point was the middle of the mesiodistal distance of the crown. Five minutes later, the teeth were isolated and the endodontic procedure was started.
Intervention Type
Device
Intervention Name(s)
Intraligamentary Injection Group
Intervention Description
An infiltration was performed at the buccal side of the affected tooth with 0.5 mL using a normal syringe and a 27-G needle. Then, an intraligamentary injection was performed with a special pressure injection syringe (Sopira Citoject, Kulzer, Hanau, Germany) and a 30-G needle. The needle was placed alongside the tooth and inserted at a 30 angle relative to the longitudinal axis of the crown with the needle between the teeth and the bone. Then, in the mesiobuccal, distobuccal, mesiolingual and distolingual portions of teeth, 0.18 mL of the solution was injected. Five minutes later, the teeth were isolated and the endodontic procedure was started.
Primary Outcome Measure Information:
Title
The success of anesthesia techniques
Description
Heft-Parker visual analog scale (HPVAS) was used to evaluate the patient's subjective pain and convert it to quantitative values. The pain was classified as follows: 0, no pain as "1"; 1-54 mm, mild pain as "2"; 55-112 mm, moderate pain as "3"; and 114-170 mm, severe pain as "4". If the VAS value is 1 and 2, anesthesia is considered successful, if 3 and 4, anesthesia is considered unsuccessful. HPVAS-1 determines the VAS value of pain response to cold test. The VAS value of the pain response at the start of the treatment is HPVAS-2. The VAS value of the pain response on entering the pulp chamber HPVAS-3: The VAS value of the pain response during pulp extirpation was recorded as HPVAS-4.
Time Frame
0-2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Systemically healthy patients The absence of periapical pathology Not sensitive to articaine or epinephrine No facial paresthesia Not taking any analgesic drug 6 hours before treatment Not taking any medication that interferes with anesthesia, such as tricyclic antidepressants and beta-blockers The absence of pathosis in areas planned for injection Not pregnant The absence of pathologic periodontal pockets during probing Patients with a mandibular first molar tooth exhibiting symptomatic irreversible pulpitis Exclusion Criteria: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Şehnaz Yılmaz, DDS,PhD
Organizational Affiliation
Çukurova University, Faculty of Dentistry
Official's Role
Principal Investigator
Facility Information:
Facility Name
Çukurova University, Faculty of Dentistry, Clinic of Endodontics
City
Adana
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
It has been collected Visual Analog Scale (VAS) forms from the participants as data. Each participants was marked four times from the beginning to the end of the treatment.
IPD Sharing Time Frame
Six months after publication
IPD Sharing Access Criteria
Data will be shared only if requested by the editor or referees of the journal that submitted for publication.
Citations:
PubMed Identifier
22794202
Citation
Parirokh M, Yosefi MH, Nakhaee N, Manochehrifar H, Abbott PV, Reza Forghani F. Effect of bupivacaine on postoperative pain for inferior alveolar nerve block anesthesia after single-visit root canal treatment in teeth with irreversible pulpitis. J Endod. 2012 Aug;38(8):1035-9. doi: 10.1016/j.joen.2012.04.012. Epub 2012 May 30.
Results Reference
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PubMed Identifier
35947082
Citation
Habib MFOM, Tarek S, Teama SME, Ezzat K, El Boghdadi RM, Marzouk A, Fouda MY, Gawdat SI, Bedier MM, Amin SAW. Inferior alveolar nerve block success of 2% mepivacaine versus 4% articaine in patients with symptomatic irreversible pulpitis in mandibular molars: A randomized double-blind single-centre clinical trial. Int Endod J. 2022 Nov;55(11):1177-1189. doi: 10.1111/iej.13810. Epub 2022 Aug 20.
Results Reference
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Anesthesia Techniques in Symptomatic Mandibular Molars With Irreversible Pulpitis

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