Anesthesia Techniques in Symptomatic Mandibular Molars With Irreversible Pulpitis

Not Applicable

Completed

• Conditions: Anesthesia, Dental
• Interventions: Device: Intraligamentary Injection Group; Device: Inferior Alveolar Nerve Block Group

• Registration Number: NCT05839093
• Lead Sponsor: Cukurova University

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.

Study Timeline

• Study Start: 2021-12-21
• Primary Completion: 2022-03-03
• Study Completion: 2022-03-14
• Study First Submitted: 2023-04-20
• Study First Submitted QC: 2023-04-20
• Status Verified: 2023-05
• Study First Posted: 2023-05-03
• Last Update Submitted: 2023-05-03
• Last Update Posted: 2023-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

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

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intraligamentary Injection Group	Intraligamentary Injection Group	An intraligamentary injection that performed with a special pressure injection syringe (Sopira Citoject, Kulzer, Hanau, Germany) and a 30-G needle.
Inferior Alveolar Nerve Block Group	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Çukurova University, Faculty of Dentistry, Clinic of Endodontics; 🇹🇷 Adana, Turkey