Comparing the efficacy of two anesthetic solutions namely lignocaine and Ropivacaine during endodontic procedures such as root canal treatment

Phase 1

Completed

• Conditions: Pain, unspecified,

• Registration Number: CTRI/2020/05/025110
• Lead Sponsor: SThendral

Brief Summary

**COMPARISON OF THE ANESTHETIC EFFICACY OF ROPIVACAINE AND LIGNOCAINE IN PATIENTS WITH IRREVERSIBLE PULPITIS:**

**A DOUBLE BLIND RANDOMIZED CLINICAL TRIAL.**

**Introduction**

Mandibular molars with irreversibly inflamed pulps are difficult to anesthetize. A single Inferior Alveolar Nerve Block with a volume of 1.8cc is unsuccessful in      30-80 % of the patients diagnosed with irreversible pulpitis. The gold standard anesthetic solution used for Inferior Alveolar Nerve Block injection is Lignocaine Hydrochloride, which is the most commonly used formulation. Besides Lignocaine, the recently being studied anesthetic formulation Ropivacaine has been shown to have some inherent advantages so that it could be studied in conditions of irreversible pulpitis.

**Aim**

To compare the Anesthetic efficacy of 0.5% Ropivacaine and 2% Lignocaine with 1:80,000 concentration of Epinephrine for Inferior Alveolar Nerve Block injections in patients with Irreversible Pulpitis.

**Materials and Methods**

Patients with irreversible pulpitis who reported to the Department of Conservative Dentistry and Endodontics will take part in this study and will be randomized to receive conventional Inferior Alveolar Nerve Block injections containing 2ml of either 2% lignocaine with 1:80,000 epinephrine or 0.5% of Ropivacaine.  Patient’s subjective assessment of lip anesthesia, absence/presence of pulpal anesthesia will  tested by electric pulp stimulation, and absence/presence of pain during the subsequent pulpectomy procedure by using a Visual Analogue Scale.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-07
• Study Completion: 2020-10-12
• Last Update Posted: 2022-08-18

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Subjects with age range between 18 to 50 years.
• Subjects who were currently experiencing active pain in mandibular molars.
• Subjects without any systemic conditions.
• Participants should not be under any medications that would alter pain perception and 5.The subjects should be clinically diagnosed with irreversible pulpitis, determined by spontaneous pain and prolonged response to cold testing with Endofrost (Coltene-Roeko) and a positive response to electric pulp testing, with absence of any periapical radiolucency on radiographs except for a mild widening of periodontal ligament space and a vital coronal pulp on access opening.
• Every subject had atleast one opposing or contralateral molar without any deep coronal restoration, extensive caries, periodontal disease, which was used as a control while pulp testing.

Exclusion Criteria

• Patients with systemic conditions, 2.
• Pregnant and Lactating women, 3.
• Mandibular molars with periapical radiolucency, 4.
• Mandibular molars without vital pulp tissue were later excluded during endodontic procedures.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain analysed using visual analogue scale	15 mins post - injection.
45-74mm – Moderate pain	15 mins post - injection.
75-100mm – Severe pain.	15 mins post - injection.
These pain ratings were marked by the subjects	15 mins post - injection.
0-4mm – No pain	15 mins post - injection.
5-44mm – Mild pain	15 mins post - injection.

Secondary Outcome Measures

Name	Time	Method
Requirement of supplementary injection	20 minutes post-injection

Trial Locations

Locations (1)

Rajas Dental College and Hospital; 🇮🇳 Tirunelveli, TAMIL NADU, India

Rajas Dental College and Hospital

🇮🇳Tirunelveli, TAMIL NADU, India

SThendral Dr

Principal investigator

9487768379

thendralswaminathan@yahoo.com