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Clinical Trials/CTRI/2021/05/033659
CTRI/2021/05/033659Not yet recruitingNot Applicable

Comparison in the anesthetic efficacy of buccal, buccal plus palatal infiltration of 2% lidocaine and 4% articaine buccal infiltration in vital symptomatic maxillary molars: a prospective double blind randomized clinical trial.

Department of Oral Health Science Centre1 site in 1 country60 target enrollmentStarted: May 25, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
Buccal infiltration injection alone effective in the maxillary molars pulpal anesthesia

Study Overview

Brief Summary

The purpose of present study will plane the role of supplemental palatal infiltration or 4% articaine on the success rate of pulpal anesthesia of maxillary molars with symptomatic irreversible pulpitis. Sixty six adult volunteer subjects will be selected from dental OPD. The subjects should be actively experiencing pain and in good health, and none will be taking any medication that would alter pain perception. The patients were randomly divided into three groups (GROUP I, II, III) twenty each. Patients will mark their pretreatment pain on a 170-mm HP VAS (12).  Patients will receive in  GROUP I:  buccal infiltration1 of 1.8 mL lidocaine plus dummy palatal injection (BL),  GROUP II) buccal plus palatal  infiltrations of 2 mL lidocaine (BLL) and GROUP III buccal infiltration of 1.8 mL articaine plus dummy lingual injection (BA). The patients will be asked to rate their pain on HP VAS after 20 minutes of the infiltration during the conventional access opening procedure after rubber dam application. Success will be defined as no pain or weak/mild pain during endodontic access preparation and instrumentation (Heft-Parker VAS score<55mm). Age with initial and post injection pain of the subjects will be evaluated using multiple comparison analyses of variance (Kruskal-Wallis) and t tests at P < .05. Anesthetic success of all groups will be compared by using nonparametric chi-square χ2 test.

Study Design

Study Type
Interventional
Allocation
Computer generated randomization
Masking
Participant, Investigator and Outcome Assessor Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 50.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •The inclusion criteria for the study were as follows: moderate to severe pain in the maxillary first molar, a prolonged response to cold testing with an ice stick and an electric pulp tester (Kerr Pulp Tester; Analytic Technology Corp, Redmond, WA), the absence of any periapical radiolucency on radiographs except for a widened periodontal ligament, a vital coronal pulp on access opening, and the ability of the subject to understand the use of pain scales.
  • •The subjects were in good health, and none were taking any medication that would alter pain perception, as determined by oral questioning and a written questionnaire.

Exclusion Criteria

  • •The exclusion criteria for the study were as follows: subjects younger than 18 years of age or older than 50 years of age, any known sensitivity to either 2% lidocaine or 4% articaine or epinephrine, patients having active pain in more than 1 maxillary molar, subject taking any pain-relieving medication including over-the-counter analgesics at least 12 hours before enrollment in the study, and swelling near the tooth in question and having a tooth not suitable for simple restorative treatment because of extensive caries or periodontal problems.

Outcomes

Primary Outcomes

Buccal infiltration injection alone effective in the maxillary molars pulpal anesthesia

Time Frame: 2 hours

Secondary Outcomes

  • 3.4% articaine with adrenaline is more effective than 2% lidocaine with adrenaline as an infiltration anaesthetic(2 hours)

Investigators

Sponsor
Department of Oral Health Science Centre
Sponsor Class
Research institution and hospital

Study Sites (1)

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