Clinical trial NCT05839093: 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
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia, Dental
Keywords: pain
irreversible pulpitis
intraligamentary injection
inferior alveolar nerve block
Lead sponsor: Cukurova University
Sponsor class: OTHER
First posted: 2023-05-03
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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:

-

Primary outcomes:
measure: The success of anesthesia techniques
timeFrame: 0-2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Çukurova University, Faculty of Dentistry, Clinic of Endodontics
Study officials:
affiliation: Çukurova University, Faculty of Dentistry
name: Şehnaz Yılmaz, DDS,PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.