Outcome of Partial Pulpotomy in Moderate and Severe Pulpitis

Обзор

The aim of the study is to compare the outcome of Partial Pulpotomy in mature permanent teeth with moderate and severe pulpitis. OBJECTIVE: Primary objective- to compare the difference in clinical and radiographic outcome of partial pulpotomy in mature permanent teeth with moderate and severe Pulpitis. Secondary objective- To evaluate and compare OHRQoL and postoperative pain after Partial Pulpotomy in teeth with Moderate Pulpitis and Severe Pulpitis. Subjects of age group 15 to 40 years will be included and divided into two groups 1. Permanent mature molars with Moderate Pulpitis 2. Permanent mature molars with Severe Pulpitis

Подробное описание

TITLE- Outcome of Partial Pulpotomy in Moderate and Severe Pulpitis It aims to answer does outcome of partial pulpotomy differ in mature permanent teeth with moderate and severe pulpitis? P (Population) - Mature permanent mandibular molars with clinical signs of irreversible pulpitis. I (Intervention) -Partial Pulpotomy in teeth with Moderate Pulpitis. C (Comparison) -Partial Pulpotomy in teeth with Severe Pulpitis. O (Outcome) -Assessment of clinical \& radiographic success at 6 and 12 months follow up

-Assessment of OHRQoL \& pain experience at baseline, post-operatively every 24 hours for 1 week Various studies showed partial pulpotomy is successful in managing cases of irreversible pulpitis. The word irreversible presents a problem as at least part of the pulp can be saved. As a result, Wolter's proposed a classification system based on severity of symptoms. However, the treatment modalities proposed under the classification system need to validated by further research. To the best of our knowledge, Careddu \& Duncan remains the only study that has explored the success of partial pulpotomy in terms of Wolter's classification but had low numbers and uneven distribution of moderate and severe pulpitis cases. No other clinical trials were found that compared the outcomes of partial pulpotomy in cases of moderate and severe pulpitis, where ambiguity still exists regarding the best treatment modality. This study trial aims to compare the difference in clinical and radiographic outcome of partial pulpotomy in mature permanent teeth with moderate and severe pulpitis.

Вмешательства

• Процедура Partial Pulpotomy in Moderate Pulpitis
  Procedure/Surgery: Outcome of partial pulpotomy in teeth with clinical signs indicative of Moderate Pulpitis. After caries removal and pulp exposure pulp tissue is amputated and pulpal wound will be irrigated with 3% NaOCl, and bleeding will be controlled by placing a cotton pellet soaked with 3% NaOCl over the pulpal wound for 2 to 3 minutes and will be repeated if required. Root canal therapy will be initiated in cases in which haemostasis is not achieved even after 10 minutes. Followed by ca
• Процедура Partial Pulpotomy in Severe Pulpitis
  Description: Procedure/Surgery: Outcome of partial pulpotomy in teeth with clinical signs indicative of Severe Pulpitis. After caries removal and pulp exposure pulp tissue is amputated and pulpal wound will be irrigated with 3% NaOCl, and bleeding will be controlled by placing a cotton pellet soaked with 3% NaOCl over the pulpal wound for 2 to 3 minutes and will be repeated if required. Root canal therapy will be initiated in cases in which haemostasis is not achieved even after 10 minutes. Foll

Первичные конечные точки

• success rate at one year [Срок оценки: Baseline to 12 months]

Вторичные конечные точки (2)

• Postoperative Pain [Срок оценки: Baseline and at 24 hours, Day 2, Day 3, Day 4, Day 5, Day 6 and Day 7 after the treatment]
• OHRQoL assessment [Срок оценки: Baseline and at 24 hours, Day 2, Day 3, Day 4, Day 5, Day 6 and Day 7 after the treatment]

Критерии участия

Критерии включения

• Patients aged 15-40 years.
• Mature permanent mandibular molars with extremely deep caries on radiograph, giving positive response to pulp sensibility test.
• For Moderate Pulpitis- strong, heightened and prolonged reaction to cold, which can last for minutes, possibly percussion sensitive and spontaneous dull pain that can be more or less suppressed with pain medication.

For Severe Pulpitis- Severe spontaneous pain and clear pain reaction to warmth and cold stimuli, often, sharp to dull throbbing pain, patients have trouble sleeping because of the pain (gets worse when lying down). Tooth is very sensitive to touch and percussion.

• Pulpal bleeding can be controlled within 10 minutes
• Patients having normal periapical status with periapical index (PAI) score ≤ 2
• Periodontally healthy teeth
• Positive response to pulp sensibility test

Критерии исключения

• Non restorable teeth
• Negative response to vitality testing
• Presence of sinus tract or soft tissue swelling
• Absence of deep carious lesions radiographically
• Radiographic signs of internal or external root resorption
• Patient had moderate to severe pain, but preferred root canal treatment
• Presence of sound dentin over pulp and pulp not exposed intraoperatively
• Pulp haemorrhage could not be arrested within 10 minutes.
• Necrotic pulp evident upon exposure
• Pregnant women
• Absence of antagonist teeth

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Индия · 1 центр

• PGIDS Rohtak — Rohtak

Идентификаторы

NCT: NCT07123025 · Prerna Yadav

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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