Postoperative Pain After Single vs Multiple-Visit Root Canal Treatment in Diabetic Patients (RCT-DM-Pain)

College of Physicians and Surgeons Pakistan

Status: Not yet enrolling

Conditions: Diabetes Mellitus; Postoperative Pain After Endodontic Treatment

Treatments: Procedure: Single-Visit Root Canal Therapy; Procedure: Multiple-Visit Root Canal Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07271511

KCD-Endo-DM-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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).

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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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Single-Visit RCT

Experimental group

Description:

Participants in this arm receive the complete root canal therapy procedure in a single clinical appointment. This includes local anesthesia, rubber dam isolation, access cavity preparation, biomechanical cleaning and shaping of the root canal system, and final obturation (filling) of the canal

Treatment:

Procedure: Single-Visit Root Canal Therapy

Multiple-Visit RCT

Active Comparator group

Description:

Participants in this arm receive root canal therapy over two separate appointments. The first visit includes local anesthesia, rubber dam isolation, access cavity preparation, and biomechanical cleaning and shaping of the root canal system, followed by the placement of an intracanal medication and a temporary restoration. The second visit involves the removal of the temporary material and the final obturation (filling) of the canal

Treatment:

Procedure: Multiple-Visit Root Canal Therapy

Procedure: Single-Visit Root Canal Therapy