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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура 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
• Процедура 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.

Первичные конечные точки

• Incidence of Moderate-to-Severe Pain at 24 Hours Post-Operation [Срок оценки: 24 Hours after the procedure]

Вторичные конечные точки (1)

• Mean Resting Pain Intensity at 24 Hours Post-Operation [Срок оценки: 24 hours after the procedure]

Критерии участия

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).

\-

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07271511 · KCD-Endo-DM-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗