Comparison of two anesthestic agents in irreversible pulpitis cases of upper first molar.

Phase 2

Completed

• Conditions: Irreversible Pulpitis

• Registration Number: CTRI/2016/12/007610
• Lead Sponsor: Syed Gufaran Ali

Brief Summary

**Aim-**

**To Compare and evaluate the anesthetic efficacy of4% Articaine and 2% Lidocaine for buccal infiltration in adult patients with irreversiblepulpitis of maxillary first molar.**

**Materials and methods:**

1.     200 adultsubjects with symptomatic irreversible pulpitis in maxillary first molar were  selected by simple sequential randomization procedure (Coin toss method).

2. They were randomly allocated to two groups Group 1 (n-100) and Group 2 (n-100). Eachgroup was further subdivided into two subgroups (n-50 each):

a.       **Group 1:**

**Group 1A:** Buccal infiltration anesthesia with 4% articaine inmales.

**Group 1B:** Buccal infiltration anesthesia with 4% articaine infemales.

b.      **Group 2:**

**Group2A:** Buccal infiltration anesthesia with 2% lidocaine inmales.

**Group 2B:** Buccal infiltration anesthesia with 2% lidocaine infemales.

3.  On random basis,50 male patients (Group 1A) were given submucosal buccal infiltration with4% articaine.  Same procedure was done for, 50 female patients (Group 1B).

4. The procedure was repeated for Group 2A and 2B by giving submucosal buccal infiltration with 2% lidocaine.

5.    After 7 min ofinjection, the patients were again asked to rate their pain on Heft-ParkerVAS.

6. The extent ofaccess preparation and/or instrumentation was recorded as within dentin,within pulpal space & the insertion of 1st instrument in thecanal till the working length using apex locator.

7.   The success was defined as “no pain (0 mm)†or “weak/mild pain (˃ 0 mm & ≤ 54 mm.)â€during endodontic access preparation & during first file insertion tillworking length, and the failure was defined as “Moderate pain (˃ 54 mm& Ë‚ 114 mm)†or “severe pain (≥ 114 mm)†during endodontic accesspreparation & during first file insertion till working length.

***Statistical analysis:***

*“U**npairedt test†and “chi-square test†was used to determine significant differenceswith 95% confidence level at P < 0.05 (SPSS software v. 20).*

***Result:***

On comparison of boththe groups, statistical analysis reveals that the anesthetic efficacy of buccalinfiltration using 4% articaine inpatients with irreversible pulpitis of maxillary 1st molar iscomparable with 2% Lidocaine. But 4% Articaine has been found to be better than2% Lidocaine because only 0.8 ml of 4% Articaine was injected as oppose to 1.6ml of 2% Lidocaine.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08-17
• Last Update Posted: 2016-12-22

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Patients having Moderate to severe pain in maxillary 1st molar tooth along with a positive response to cold testing with an ice stick & an electric pulp tester.
• The ability of the patient to understand the use of pain scales.
• The patient should be in good health & none should take any medication that would alter pain perception, as determined by oral & written questionnaire in last 24 hrs.
• Absence of any periapical radiolucency on radiographs except for a widened periodontal ligament.

Exclusion Criteria

• 1.Patients with systemic disorder like diabetes, hypertension, asthma etc.
• 2.Patient having active pain in more than one maxillary molar in same quadrant.
• 3.Subjects taking any pain relieving medication including analgesics within last 24 hrs.
• 5.Swelling associated with the tooth in question.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Both male and female patients experienced significantly less pain in Articaine group as compared to Lidocaine group.	Initial pain and pain after 7 minutes of injection
2. the anesthetic efficacy of 2% Lidocaine is less as compared to 4% Articaine.	Initial pain and pain after 7 minutes of injection
3. The anesthetic efficacy of buccal infiltration using 4% articaine is comparable with 2% Lidocaine but 4% Articaine has been found to be better than 2% Lidocaine because only 0.8 ml of 4% Articaine was injected as opposed to 1.6 ml of 2% Lidocaine.	Initial pain and pain after 7 minutes of injection

Secondary Outcome Measures

Name	Time	Method
1. In all the failed cases in both the groups, patients had moderate to severe pain while inserting the file in palatal canals only.	2. In failed cases of both the groups female patients experienced more pain as compared to the male patients, however, it is not statistically significant in Articaine group but it is significant in Lidocaine group.

Trial Locations

Locations (1)

Department Of Conservative And Endodontics And Private Clinics; 🇮🇳 Indore, MADHYA PRADESH, India

Department Of Conservative And Endodontics And Private Clinics

🇮🇳Indore, MADHYA PRADESH, India

Syed Gufaran Ali

Principal investigator

9826406933

drgufran81@gmail.com