The Effect of Buccal Infiltration Administration of Clonidine on the Success Rate of Inferior Alveolar Nerve Block
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|ClinicalTrials.gov Identifier: NCT04186299|
Recruitment Status : Not yet recruiting
First Posted : December 4, 2019
Last Update Posted : December 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|Symptomatic Irreversible Pulpitis||Drug: Clonidine Drug: Articaine Hydrochloride + Epinephrine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||The Effect of Buccal Infiltration Administration of Clonidine on the Success Rate of Inferior Alveolar Nerve Block on Mandibular Molars With Symptomatic Irreversible Pulpitis: a Randomized Double-blind Clinical Trial|
|Estimated Study Start Date :||January 2020|
|Estimated Primary Completion Date :||January 2021|
|Estimated Study Completion Date :||January 2021|
1.7mL of 1:100,000 clonidine
Each patient will receive a buccal infiltration of 1.7mL of 1:100,000 clonidine.
Active Comparator: articaine/epinephrine
1.7mL of 4% articaine with 1:100,000 epinephrine
Drug: Articaine Hydrochloride + Epinephrine
Each patient will receive a buccal infiltration of 1.7mL of 4% articaine with 1:100,000 epinephrine.
- Evaluation of success of IANB [ Time Frame: The pain level is recorded as the extent of access is achieved within dentin and while entering the pulp chamber or during initial file placement. Data of each patient will be recorded through study completion, an average of 4 hours. ]The patients will be instructed to rate any pain felt during the procedure. If they feel pain, the treatment will be stopped immediately and they rate their pain using the Heft-Parker Visual Analogue Scale (VAS). The success of the IANB is defined as the ability to penetrate dentin, enter the pulp and advance instruments into the coronal part of the canal pulp without pain or with mild pain. The VAS consists of four categories of scales on a 170mm VAS line. No pain corresponds to 0mm. Mild pain is defined as greater than 0mm and less than or equal to 54mm. Moderate pain is defined as greater 54mm and less than or equal to 114mm. Severe pain is defined as greater than 114mm. At each step, when patients report moderate to severe pain, the IANB is considered to have failed.
- Evaluation of dental anxiety [ Time Frame: The initial measurement is obtained before treatment, and 5 and 30 minutes after administration of anesthesia. Data of each patient are recorded by the end of the visit, which takes an average of 4 hours. ]Patients are instructed to rate their dental anxiety level on a VAS-Anxiety. The VAS consists of four categories of scales on a 10cm VAS line. No anxiety corresponds to 0cm. Mild anxiety is defined as greater than 0cm and less than 5.1cm. Moderate anxiety is defined as greater than or equal to 5.1cm and less than 7.0cm. Severe anxiety is defined as greater than or equal to 7.0cm.
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): NCT04186299
|Contact: Daphne Chungfirstname.lastname@example.org|
|Contact: Elham Shadmehr, DDS, MS||415-514-3546||Elham.Shadmehr@ucsf.edu|
|Principal Investigator:||Elham Shadmehr, DDS, MS||University of California, San Francisco|