Efficacy of Block Injection of an Anti Inflammatory Medicine in Patients With Mandibular Dental Pain (IANB)

Azad University of Medical Sciences

Status and phase

Completed

Phase 2

Conditions

Symptomatic Irreversible Pulpitis

Treatments

Drug: Ketorolac Tromethamine

Behavioral: Sham injection

Study type

Interventional

Funder types

Other

Identifiers

NCT03410212

IR.IAU.DENTAL.REC.1396,31

Details and patient eligibility

About

The aim of this study is to determine whether inferior alveolar nerve block of ketorolac and lidocaine would improve the success rate in teeth with symptomatic irreversible Pulpitis.

Design: In this randomized double-blind clinical trial, sixty healthy adult volunteers with including criteria have been randomly divided into two groups (n=30). Following the 5 minutes of the first IANB using 1.8 ml 2% lidocaine 2% containing 1:100000, the patients of case group have received a standard inferior alveolar nerve block injection that used 1 ml ketorolac tromethamine 30 mg/ml. The patients of the control group received a sham injection. After achieving the lip numbness, access preparation initiated after 15 minutes of initial IANB with two negative responses to the electric pulp test. Any pain during caries and dentin removal, access cavity preparation, and root canal preparation have been recorded using analog visual scale (HP-VAS). The success was considered as none or mild pain during treatment. The data have been analyzed using Mann-U-Whitney test.

Intervention main outcome measures: Pain during caries and dentin removal access cavity preparation, and root canal preparation using VAS.

Full description

The aim of this study is to determine whether inferior alveolar nerve block of ketorolac and lidocaine would improve the success rate in teeth with symptomatic irreversible Pulpitis. Design: In this randomized double-blind clinical trial, sixty healthy adult volunteers with including criteria have been randomly divided into two groups (n=30). All patients have been received standard inferior alveolar nerve block injection that used 1.8 ml 2% lidocaine 2% containing 1:100000 after negative aspiration. After 5 minutes 30 patients have received a standard inferior alveolar nerve block injection that used 1 ml ketorolac tromethamine 30 mg/ml. the other 30 patients received a sham injection. After achieving the lip numbness, the pulp anesthesia has been evaluated after 5 minutes by using electric pulp tester (Pakell Inc, Edgewood, NY). Endodontic access preparation initiated after 15 minutes of initial IANB with two negative responses to the electric pulp test. Any pain during caries and dentin removal, access cavity preparation, and root canal preparation have been recorded using analog visual scale (HP-VAS). The success was considered as none or mild pain during treatment. The data have been analyzed using Mann-U-Whitney test.Participants including major eligibility criteria: all patients with symptomatic irreversible pulpitis (HP VAS ≥54) of a mandibular molar tooth without systemic diseases; nonsmoking; without any medicine consumption or analgesic and sedation Intervention Main outcome measures: Pain during caries and dentin removal, access cavity preparation, and root canal preparation using VAS.

Enrollment

60 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

patients with age ranged 18-65
without systemic diseases;
without any medicine consumption;
nonsmoking;
nonpregnant;
non-breastfeeding;
with symptomatic irreversible pulpitis (Visual Analog Scale ≥ 54) in one mandibular
the molar that needs root canal treatment

Exclusion criteria

patients under 18 or above 65 years old
with systemic diseases;
with any medicine consumption;
smoking;
pregnant;
breastfeeding;
without symptomatic irreversible pulpitis (Visual Analog Scale ≥ 54) in one mandibular
the molar that needs root canal treatment