Dental Caries Clinical Trial
Official title:
Randomized Clinical Trial on the Effectiveness of the Intraligamentary Anesthesia and Inferior Alveolar Nerve Block on Pain During Dental Treatment
Verified date | September 2020 |
Source | University Medicine Greifswald |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Objective: To compare the effectiveness and complications of intraligamentary anesthesia
(ILA) with conventional inferior alveolar nerve block (IANB) during injection and dental
treatment of mandibular posterior teeth.
Materials and Methods: In this randomized, prospective clinical trial, 72 patients (39 males,
33 females) patients scheduled for dental treatment of mandibular posterior teeth, were
randomly allocated to ILA group (n=35) received ILA injection or IANB group (n=37) received
the conventional IANB. Our primary outcome was to assess pain during the injection as well as
pain and stress (discomfort) during dental treatment, using the Numeric Rating Scale (NRS)
from 0 to 10 (0 = no pain, 10= the worst pain imaginable). Whereas; recording 24 hours
postoperative complications were our Secondary outcomes.
Status | Completed |
Enrollment | 72 |
Est. completion date | June 15, 2019 |
Est. primary completion date | March 1, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility |
Inclusion Criteria: - patients requiring regular dental in permanent mandibular posterior teeth under local anesthesia Exclusion Criteria: - Patients with a clinical or radiographic sign of acute abscess, pus or peri-radicular pathology - Patients with a systemic disease requiring special considerations during their dental treatment - Patients with contra-indications for any of the components of the anesthetic solution (allergy to articaine, epinephrine, and sulfite) |
Country | Name | City | State |
---|---|---|---|
Germany | University Medicine of Greifswald | Greifswald |
Lead Sponsor | Collaborator |
---|---|
University Medicine Greifswald |
Germany,
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* Note: There are 19 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The intensity of pain during the injection | The intensity of pain during the injection of the LA to be assessed by the patient using Numeric Rating Scale. The Numeric Rating Scale, (NRS 0-10; 0 representing no pain at all and 10 representing the worst pain imaginable) is a valid instrument to measure pain. | immediately after the injection of LA | |
Primary | The intensity of pain during the dental treatment | The intensity of pain during the dental treatment to be assessed by the patient using Numeric Rating Scale. The Numeric Rating Scale, (NRS 0-10; 0 representing no pain at all and 10 representing the worst pain imaginable) is a valid instrument to measure pain. | immediately after the dental treatment | |
Primary | The intensity of stress (discomfort) | The intensity of stress during the dental treatment to be assessed by the patient using Numeric Rating Scale. The Numeric Rating Scale, (NRS 0-10; 0 representing no discomfortable at all and 10 representing the maximal discomfortable very imaginable) is a valid instrument to measure stress (discomfort) | immediately after the dental treatment | |
Secondary | Postoperative complications | Recording any postoperative complications which could be occurred (Nerve injury or any other temporary irritations like the pain at the site of injection, signs of intravascular injection, lip-bit injury) | 24 hours |
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