Postoperative Pain After Single vs Multiple-Visit Root Canal Treatment in Diabetic Patients

NCT ID: NCT07271511

Last Updated: 2025-12-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-15
• Study Completion Date: 2026-06-15

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.

Conditions

Diabetes Mellitus; Postoperative Pain After Endodontic Treatment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single-Visit RCT

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

Group Type: EXPERIMENTAL

Single-Visit Root Canal Therapy

Intervention Type: PROCEDURE

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

Multiple-Visit RCT

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

Group Type: ACTIVE_COMPARATOR

Multiple-Visit Root Canal Therapy

Intervention Type: PROCEDURE

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.

Single-Visit Root Canal Therapy

Intervention Type: PROCEDURE

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

Interventions

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.

Intervention Type: 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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

College of Physicians and Surgeons Pakistan

OTHER

Sponsor Role: lead

Responsible Party

Faiz ur rahman

Postgraduate Resident, Department of Operative Dentistry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Madeeha murtaza

Role: CONTACT

madi.shahid14@gmail.com

+923400178482

Other Identifiers

KCD-Endo-DM-001

Identifier Type: -

Identifier Source: org_study_id