Diabetes Mellitus, Postoperative Pain After Endodontic Treatment
Conditions
Keywords
Single-Visit Endodontics, Multiple-Visit Endodontic, Root canal therapy
Brief summary
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.
Detailed description
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.
Interventions
PROCEDURESingle-Visit Root Canal Therapy
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
PROCEDUREMultiple-Visit Root Canal Therapy
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.
Sponsors
College of Physicians and Surgeons Pakistan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a two-arm, parallel-group randomized controlled trial. Participants are assigned to receive either the single-visit or multiple-visit root canal therapy and are followed identically over the same time period.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Patients aged between 12 and 60 years. Diagnosed with Type 1 or Type 2 Diabetes Mellitus. In need of root canal treatment on a single-rooted tooth. A clinical diagnosis of either irreversible pulpitis or necrotic pulp in the indicated tooth. Willingness and ability to understand and provide written informed consent (and assent with parental consent for minors). \-
Exclusion criteria
* Pregnancy. Known history of allergy to local anesthetics. Presence of large periapical radiolucent lesions (typically defined as \>5mm in diameter). Current use of long-term analgesic or anti-inflammatory medication (which could alter pain perception). Teeth with complex root canal anatomy (e.g., calcified canals, C-shaped canals) that would complicate standard treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Moderate-to-Severe Pain at 24 Hours Post-Operation | 24 Hours after the procedure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Resting Pain Intensity at 24 Hours Post-Operation | 24 hours after the procedure | 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. |
Contacts
CONTACTMadeeha murtaza
Outcome results
None listed