A Phase 2 interventional study of Ketorolac Tromethamine and Placebo in Failed Mechanical Induction, sponsored by Nahid Mohammadzadeh Akhlaghi. Completed at 1 site in Iran, Islamic Republic of. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-09-02.
Sponsored by Nahid Mohammadzadeh Akhlaghi · Phase 2, Interventional, and Treatment
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. Forty adult volunteers with including criteria has been randomly divided into two groups (n=20). All patients received standard inferior alveolar nerve block injection. After achieving the lip numbness, one group received a buccal infiltration of Ketorolac and the other one received a buccal infiltration of Normal Saline as placebo. Any pain during root canal treatment has been recorded using analog visual scale. The success was considered as none or mild pain during treatment. The data have been analyzed using Mann-U-Whitney and chi-squared tests.
Objectives:
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.
Nahid Mohammadzadeh Akhlaghi is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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A buccal infiltration of 30 mg/mL of Ketorolac Tromethamine was applied for the patients in case group.
Drug: Ketorolac Tromethamine
A buccal infiltration of Normal Saline was applied for the patients in control group.
Drug: Placebo
One group received a buccal infiltration of Ketorolac Tromethamine
Also known as: Toradol
buccal infiltration of Normal Saline.
Also known as: Normal Saline
Efficacy of Ketorolac infiltration on success rate of inferior alveolar nerve block
Time frame: One week
This study is completed, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.
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Nahid Mohammadzadeh Akhlaghi