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

March 16, 2026 updated by: Faiz ur rahman, College of Physicians and Surgeons Pakistan

Comparative Analysis of Postoperative Pain Following Single vs Multiple-Visit Root Canal Therapy in Single-Rooted Teeth of Diabetic Patients: A Randomized Controlled Trial

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
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
Active Comparator: 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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Moderate-to-Severe Pain at 24 Hours Post-Operation
Time Frame: 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.
24 Hours after the procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Resting Pain Intensity at 24 Hours Post-Operation
Time Frame: 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.
24 hours after the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

College of Physicians and Surgeons Pakistan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 15, 2026

Primary Completion (Estimated)

June 15, 2026

Study Completion (Estimated)

June 15, 2026

Study Registration Dates

First Submitted

November 22, 2025

First Submitted That Met QC Criteria

December 5, 2025

First Posted (Actual)

December 9, 2025

Study Record Updates

Last Update Posted (Actual)

March 18, 2026

Last Update Submitted That Met QC Criteria

March 16, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KCD-Endo-DM-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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