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

NCT07271511 | Not Yet Recruiting

• 1 other identifier: KCD-Endo-DM-001
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetes Mellitus; Postoperative Pain After Endodontic Treatment

Keywords

Single-Visit Endodontics; Multiple-Visit Endodontic; Root canal therapy

Outcome Measures

Primary Outcomes (1)

• Incidence of Moderate-to-Severe Pain at 24 Hours Post-Operation

  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 Outcomes (1)

• Mean Resting Pain Intensity at 24 Hours Post-Operation

  24 hours after the procedure

Study Arms (2)

Single-Visit RCT

EXPERIMENTAL

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

Multiple-Visit RCT

ACTIVE COMPARATOR

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; Procedure: Multiple-Visit Root Canal Therapy

Interventions

Single-Visit Root Canal Therapy 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; Single-Visit RCT

Multiple-Visit Root Canal Therapy 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.

Multiple-Visit RCT

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• College of Physicians and Surgeons Pakistan: lead

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Madeeha murtaza

CONTACT

+923400178482; madi.shahid14@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postgraduate Resident, Department of Operative Dentistry

Model Details: 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.

Study Record Dates

• First Submitted: November 22, 2025
• First Posted: December 9, 2025
• Study Start (Estimated): May 15, 2026
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): June 15, 2026
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share