Anesthesia Techniques in Symptomatic Mandibular Molars With Irreversible Pulpitis

NCT05839093 | Completed

• 1 other identifier: TDH-2020-12818
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia, Dental

Keywords

pain; irreversible pulpitis; intraligamentary injection; inferior alveolar nerve block

Outcome Measures

Primary Outcomes (1)

• 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.

  0-2 hours

Study Arms (2)

Inferior Alveolar Nerve Block Group

ACTIVE COMPARATOR

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

Intraligamentary Injection Group

EXPERIMENTAL

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

Interventions

Inferior Alveolar Nerve Block Group DEVICE

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.

Inferior Alveolar Nerve Block Group

Intraligamentary Injection Group DEVICE

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.

Intraligamentary Injection Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Cukurova University: lead

Study Sites (1)

Çukurova University, Faculty of Dentistry, Clinic of Endodontics

Adana, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 22794202 BACKGROUND

• 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.

  PMID: 35947082 BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Şehnaz Yılmaz, DDS,PhD

  Çukurova University, Faculty of Dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Professor

Study Record Dates

• First Submitted: April 20, 2023
• First Posted: May 3, 2023
• Study Start: December 21, 2021
• Primary Completion: March 3, 2022
• Study Completion: March 14, 2022
• Last Updated: May 6, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Six months after publication
• Access Criteria: Data will be shared only if requested by the editor or referees of the journal that submitted for publication.

Locations

TU (1)