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

NCT ID: NCT03410212

Last Updated: 2019-01-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-15
• Study Completion Date: 2018-11-15

Brief Summary

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.

Detailed 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.

Conditions

Symptomatic Irreversible Pulpitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Ketorolac Tromethanine

In the experimental group, 30mg/mL, ketorolac tromethamine will be injected as same as the first IANB and 5 minutes following it.

Group Type: ACTIVE_COMPARATOR

Ketorolac Tromethamine

Intervention Type: DRUG

The 30mg/mL vial of Ketorolac will be injected as second inferior alveolar nerve block and the success of anesthesia will be evaluated using visual analog scale.

No injection

In the control group, 5 minutes following the IANB, the sham injection will be provided at the same place of the first injection.

Group Type: SHAM_COMPARATOR

Sham injection

Intervention Type: BEHAVIORAL

In the control group, the sham injection will be provided at the same place of the first inferior alveolar nerve block but any injection would be done.

Interventions

Ketorolac Tromethamine

The 30mg/mL vial of Ketorolac will be injected as second inferior alveolar nerve block and the success of anesthesia will be evaluated using visual analog scale.

Intervention Type: DRUG

Sham injection

In the control group, the sham injection will be provided at the same place of the first inferior alveolar nerve block but any injection would be done.

Intervention Type: BEHAVIORAL

Other Intervention Names

Toradol, Acular, Sprix

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Azad University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Nahid Mohammadzadeh Akhlaghi

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Dental Branch, AZad UMS

Tehran, , Iran

Countries

Iran

Other Identifiers

IR.IAU.DENTAL.REC.1396,31

Identifier Type: -

Identifier Source: org_study_id