Effectiveness of Pulpotomy vs. Root Canal Treatment in Extremely Deep Caries

Официальное название

Effectiveness of Pulpotomy vs. Root Canal Treatment in Extremely Deep Caries: A Randomized Controlled Trial Conducted in Supervised Undergraduate Clinics

Обзор

Recent clinical trials comparing pulpotomy versus root canal treatment (RCT) have shown promising outcomes; however, the current evidence lacks generalisability to general practitioners. It remains to be elucidated whether these favourable results can be replicated in a primary care setting. This study aims to address that gap by involving senior dental students undergoing supervised university education and training, with the potential to inform future best practice guidelines and promote the adoption of vital pulp therapy (VPT) as a predictable treatment alternative in the general dental population. The clinical procedure involves complete caries-free excavation carried out under rubber dam isolation. After confirming vital pulp status-demonstrated by bleeding upon entry, participants will be randomised to receive one of two treatments: RCT or full pulpotomy. Outcomes will include clinical and radiographic success or failure of the intervention at 12 months. Additionally, patient-reported outcomes will be collected, specifically pain experienced and the use of analgesia during the immediate post-operative period (days 3 and 7).

Вмешательства

• Процедура Full Pulpotomy
  Preservation of vital pulp tissue for tooth survival.
• Процедура root canal treatment and intracanal medicament
  Root canal treatment as a comparator to pulpotomy.

Первичные конечные точки

• Primary Outcome [Срок оценки: 12 months]

Вторичные конечные точки (1)

• Secondary Outcome [Срок оценки: 12 months]

Критерии участия

Критерии включения

• Aged 12 years or older
• Mature maxillary or mandibular permanent tooth with extremely deep restorations/caries penetrating the entire thickness of dentine on the radiograph without a radiopaque zone separating the lesion from the pulp (Bjorndal et al., 2019)
• Tooth may or may not be symptomatic at the time of recruitment but must be responsive to cold and EPT sensibility testing
• Tooth is restorable and can be adequately isolated during treatment
• One tooth per patient

Критерии исключения

• Teeth with difficult access and unpredictable isolation using a rubber dam
• Teeth aberrant root canal morphology, extreme root curvatures (>30 degrees), calcified canals/sclerosed pulp
• Teeth indicated for elective root canal treatment for restorative purposes
• Teeth with apical periodontitis
• Presence of apical radiolucency
• Any evidence of purulence or excessive bleeding that cannot be controlled with a cotton pellet with 1.25% hypochlorite for 10 minutes
• History of trauma to the tooth
• Teeth with active periodontal disease (pocket depth >5mm)
• Patients with complex medical histories that may affect their caries experience and healing ability (immunocompromised, radiotherapy etc.)
• Patients who are pregnant or breast-feeding
• Patients who are unable to consent

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

Простое слепое

Основная цель

Лечение

Центры проведения

Сингапур · 1 центр

• National University Centre For Oral Health Singapore (NUCOHS) — Singapore

Идентификаторы

NCT: NCT07242742 · 2024-4505

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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