Efficacy of Ketorolac Buccal Infiltration on Success Rate of Inferior Alveolar Nerve Block
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|ClinicalTrials.gov Identifier: NCT02536430|
Recruitment Status : Completed
First Posted : August 31, 2015
Last Update Posted : September 2, 2015
|Condition or disease||Intervention/treatment||Phase|
|Failed Mechanical Induction||Drug: Ketorolac Tromethamine Drug: Placebo||Phase 2|
The aim of this study was to determine whether combining an intraoral injection of a non steroidal anti-inflammatory drug (Ketorolac), in association with conventional inferior alveolar nerve block, would improve the success rate in teeth with irreversible pulpitis.
Design: Randomized double blind clinical trial
Setting and conduct: Forty adult volunteers will randomly divide into two groups (n=20). All patients will receive standard inferior alveolar nerve block injection of 4% Articaine with 1:100000 epinephrine and supplemental buccal infiltration of 0.9 mL 4% Articaine with 1:100000 epinephrine. After five minutes when the lip numbness was achieved, one group received supplemental buccal infiltration of 30 mg/mL of Ketorolac Tromethamine and other group received buccal infiltration of normal saline. Endodontic access preparation initiated after 15 minutes of initial IANB with two negative responses to the electric pulp test. Pain during caries and dentin removal, access cavity preparation and canal length measurements has been recorded using visual analog scale (VAS). The success was considered as none or mild pain during the treatment. The data have been analyzed using Mann-U-Whitney and chi-squared tests.
Participants including major eligibility criteria: all patients with symptomatic irreversible pulpitis (Heft Parker VAS ≥54) of a mandibular molar tooth without systemic diseases; non smoking; without any medicine consumption or analgesic and sedation Intervention: Ketorolac infiltration
Main outcome measures : Pain during caries and dentin removal , access cavity preparation and canals length measurements using VAS.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Efficacy of Ketorolac Buccal Infiltration on Success Rate of Inferior Alveolar Nerve Block in Patients With Irreversible Pulpitis: A Prospective, Randomized, Double-blind Clinical Trial|
|Study Start Date :||March 2015|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||August 2015|
Active Comparator: Buccal infiltration of Ketorolac
A buccal infiltration of 30 mg/mL of Ketorolac Tromethamine was applied for the patients in case group.
Drug: Ketorolac Tromethamine
One group received a buccal infiltration of Ketorolac Tromethamine
Other Name: Toradol
Placebo Comparator: buccal infiltration of Normal Saline
A buccal infiltration of Normal Saline was applied for the patients in control group.
buccal infiltration of Normal Saline.
Other Name: Normal Saline
- Efficacy of Ketorolac infiltration on success rate of inferior alveolar nerve block [ Time Frame: One week ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02536430
|Iran, Islamic Republic of|
|Dental Branch, AZad UMS|
|Tehran, Iran, Islamic Republic of|
|Principal Investigator:||Nahid Mohammadzadeh Akhlaghi, DDS,MDS||Associate Professor|