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NCT Number: NCT07271511

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Madeeha murtaza

CONTACT

[email protected]

+923400178482

Sponsors and collaborators

Lead sponsor

College of Physicians and Surgeons Pakistan

Other

Registry information

Official study 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

Acronym: RCT-DM-Pain

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Dec 9, 2025
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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