Postoperative Pain After Single vs Multiple-Visit Root Canal Treatment in Diabetic Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Single-Visit Root Canal Therapy, Multiple-Visit Root Canal Therapy.
- Who it may be relevant to
- Registry conditions: Diabetes Mellitus, Postoperative Pain After Endodontic Treatment. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparative Analysis of Postoperative Pain Following Single vs Multiple-Visit Root Canal Therapy in Single-Rooted Teeth of Diabetic Patients: A Randomized Controlled Trial
Overview
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
- Procedure Single-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 - Procedure Multiple-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.
Primary outcome measures
- Incidence of Moderate-to-Severe Pain at 24 Hours Post-Operation [Time frame: 24 Hours after the procedure]
Secondary outcome measures (1)
- Mean Resting Pain Intensity at 24 Hours Post-Operation [Time frame: 24 hours after the procedure]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07271511 · KCD-Endo-DM-001