A short description of the clinical study, including a brief statement of the clinical study's hypothesis, written in language intended for the lay public.
This study compares post-treatment pain after root canal therapy done in one visit versus two visits for patients with diabetes. Root canal treatment can sometimes cause pain afterwards, and it is unclear if the number of visits makes a difference, especially for diabetic patients who may have different healing and pain responses. We will randomly assign 200 diabetic patients needing a root canal on a single-rooted tooth to either have the entire procedure completed in a single appointment or split over two appointments. Patients will record their pain levels on a standard scale at 24 hours, 72 hours, and one week after the procedure. We hypothesize that there will be no significant difference in pain levels between the two treatment approaches. The results will help dentists decide the best treatment plan for their diabetic patients without worrying about causing more pain.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
A standard non-surgical root canal treatment protocol where the entire procedure-from access opening and canal instrumentation to final obturation-is completed in one continuous session, without the use of inter-appointment intracanal medication
A standard non-surgical root canal treatment protocol performed over two clinical appointments. The first visit involves canal preparation and dressing with an intracanal medicament. The final visit, scheduled after an interim period, involves the removal of the medicament and the completion of the root canal filling.
Incidence of Moderate-to-Severe Pain at 24 Hours Post-Operation
Measurement Tool: Numeric Rating Scale (NRS), an 11-point scale from 0 (no pain) to 10 (worst imaginable pain). Unit of Measure: Percentage (%) of patients. Description: The proportion of patients reporting a pain intensity score of 4 or greater on the NRS during movement (e.g., coughing or ambulation) at the 24-hour post-operative time point.
Time frame: 24 Hours after the procedure
Mean Resting Pain Intensity at 24 Hours Post-Operation
Measurement Tool: Numeric Rating Scale (NRS), an 11-point scale from 0 (no pain) to 10 (worst imaginable pain). Unit of Measure: Percentage (%) of patients. Description: The proportion of patients reporting a pain intensity score of 4 or greater on the NRS during movement (e.g., coughing or ambulation) at the 24-hour post-operative time point.
Time frame: 24 hours after the procedure
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