Anesthesia Techniques in Symptomatic Mandibular Molars With Irreversible Pulpitis

Sponsor

Cukurova University (Other)

Overall Status

Completed

CT.gov ID

NCT05839093

Collaborator

(none)

210

Enrollment

Location

Arms

2.7

Actual Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Anesthesia, Dental	Device: Inferior Alveolar Nerve Block Group Device: Intraligamentary Injection Group	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

210 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Dec 21, 2021

Actual Primary Completion Date :

Mar 3, 2022

Actual Study Completion Date :

Mar 14, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Inferior Alveolar Nerve Block Group 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.	Device: Inferior Alveolar Nerve Block Group 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.
Experimental: Intraligamentary Injection Group An intraligamentary injection that performed with a special pressure injection syringe (Sopira Citoject, Kulzer, Hanau, Germany) and a 30-G needle.	Device: Intraligamentary Injection Group 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.

Arm

Intervention/Treatment

Active Comparator: Inferior Alveolar Nerve Block Group

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.

Device: Inferior Alveolar Nerve Block Group

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.

Experimental: Intraligamentary Injection Group

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

Device: Intraligamentary Injection Group

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.

Outcome Measures

Primary Outcome Measures

The success of anesthesia techniques [0-2 hours]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Çukurova University, Faculty of Dentistry, Clinic of Endodontics	Adana		Turkey

Sponsors and Collaborators

Cukurova University

Investigators

Principal Investigator: Şehnaz Yılmaz, DDS,PhD, Çukurova University, Faculty of Dentistry

Study Documents (Full-Text)

Study Protocol and Statistical Analysis Plan - May 1, 2023

More Information

Publications

Responsible Party:

Şehnaz Yilmaz, DDS, PhD, Associated Professor, Cukurova University

ClinicalTrials.gov Identifier:

NCT05839093

Other Study ID Numbers:

TDH-2020-12818

First Posted:

May 3, 2023

Last Update Posted:

May 6, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Şehnaz Yilmaz, DDS, PhD, Associated Professor, Cukurova University

pain

irreversible pulpitis

intraligamentary injection

inferior alveolar nerve block

Additional relevant MeSH terms:

Pulpitis

Study Results

No Results Posted as of May 6, 2023