- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07610057
R. Officinalis as Pulpotomy Agent in Permanent Teeth With Irreversible Pulpitis
Comparative Clinical and Radiographic Evaluation of Rosmarinus Officinalis Versus Mineral Trioxide Aggregate as Pulpotomy Medicament in Vital Mature Permanent Teeth With Irreversible Pulpitis
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
Traditionally, teeth with irreversible pulpitis have been treated either by root canal therapy or extraction, yet root canal treatment, although considered the gold standard, still presents limitations because it is technique-sensitive, invasive, time-consuming, and costly. To address these issues, more affordable and minimally invasive alternatives are being explored. With better understanding of the regenerative and healing abilities of inflamed pulp, along with the development of biologically active materials, vital pulp therapy is now increasingly viewed as a suitable alternative for managing irreversible pulpitis. Mineral trioxide aggregate is widely accepted as the current gold standard, but its drawbacks-including high cost, extended setting time and potential tooth discoloration-remain significant concerns. As a result, newer materials are being evaluated that are more cost-effective while avoiding these disadvantages.
One such material, Rosmarinus officinalis, has been used in vital pulp therapy of primary molars and has shown promising results. Despite the documented antimicrobial and anti-inflammatory properties of R. officinalis, its use as a pulpotomy agent in permanent teeth with irreversible pulpitis has not yet been investigated. This study aims to compare the outcomes of pulpotomy treatment using R. officinalis extract both clinically and radiographically versus MTA. This may help provide an alternative to RCT and a more economical option than MTA, while aiming for comparable effectiveness and addressing the limitations associated with MTA. Healthy young adults exhibiting signs and symptoms of irreversible pulpitis in at least one permanent posterior tooth, showing no periapical radiolucency in a periapical x-ray, along with the absence of swelling or sinus tract formation will be selected. Only the teeth with hemostasis achieved following the removal of coronal pulp will be included.
A randomized control trail will be conducted, wherein participants will be randomly assigned, using lottery method, to two groups, each consisting of 50 individuals of age 18-40 years of both sexes. After administration of anesthesia and isolation using a rubber dam, a sterile diamond round bur in a high-speed handpiece with water spray will used to remove enamel caries and carbide round bur in slow speed handpiece is used to remove dentinal caries. After the access opening, the coronal pulp will be removed up to the level of the canal orifice using a spoon excavator. After rinsing with sterile saline, hemostasis will be achieved by placing damp cotton soaked in saline. For group A, cotton will be dipped in R-officinalis extract, and placed over radicular pulp for 5 minutes and the pulp chamber will be sealed with a thick paste of aqueous R. officinalis extract with zinc oxide powder and for group B, white MTA will be prepared according to the manufacturer's instructions and placed in the pulp chamber compacted with a damp cotton pellet. Both will be restored with glass ionomer followed by direct composite. An immediate post-op periapical x-ray will be exposed. For clinical and radiographical evaluation patients will be recalled for follow-up at 1 week, 3 month and 6 months. Statistical analysis will be performed at the significance level of p= 0.05.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Zoha Nasir, BDS
- Номер телефона: +923224056794
- Электронная почта: zohanasirsheikh@gmail.com
Места учебы
-
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Punjab Province
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Lahore, Punjab Province, Пакистан, 54000
- Punjab Dental Hospital, Lahore .
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria
- Healthy patients (ASA classification 1 and 2) of age range of 18-40 of both sexes would be included.
- Vital mature permanent posterior teeth with deep caries approaching the pulp as seen on periapical x-ray.
- Pain indicative of irreversible pulpitis (spontaneous pain or pain exacerbated by a cold stimulus which could last from a few seconds to hours), which a cold test could reproduce.
- Tooth will be selected on the basis of working diagnosis i.e. successful hemostasis within 5 minutes after removal of coronal pulp.
- Absence of clinical signs or symptoms suggesting a non-vital tooth such as tenderness to percussion or palpation, mobility, presence of abscess, soft tissue swelling or suppurating sinus.
- Absence of radiographic changes as; furcation or periapical pathology, internal or external root resorption or calcification in the canals.
- The tooth structure of selected teeth should be restorable after completion of the treatment
Exclusion Criteria:
- Patients with ASA classification 3, 4 ,5 and 6 would be
- Patients taking antibiotics within last 2 weeks.
- Teeth with pulp necrosis, cracked tooth, internal or external resorption, calcified canals, acute or chronic apical periodontitis with an associated sinus tract or periapical radiolucency.
- Periodontally compromised tooth.
- Uncooperative patients or failure to obtain authorization from patients.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Двойной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Активный компаратор: Control Group with MTA pulpotomy
Pulpotomy Medicaent in control group
|
MTA shall be mixed according to the manufacturer's instructions (PD SWISS).
After achieving a creamy mixture, MTA shall be delivered to the pulp chamber using an amalgam carrier to a 1-2mm thickness.
Using a moist pellet, it will be condensed gently over the exposed pulp stumps.
Once an initial set of MTA is achieved, the access cavity shall be restored with a glass ionomer cement and composite restoration.
|
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Экспериментальный: Intervention
R. officinalis as pulpotomy medicament
|
A sterile cotton pellet dipped and squeezed in 6.25% aqueous extract of R-officinalis will be placed over the radicular pulp for 5 minutes.
Then, the pulp chamber will be sealed with a thick paste aqueous extract of R. officinalis and zinc oxide powder.
The access cavity shall be restored with glass ionomer cement and a composite restoration.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Pain After Intervention, Tenderness to palpation, percussion , Swelling
Временное ограничение: Preop Post op after 1 week, 1month 3 month 6 month
|
The incidence and intensity of pain will be assessed postoperatively using the Visual Analogue scale. Pain intensity will be noted as no pain (0-4mm), mild pain (5-44), moderate pain (45-74mm) and severe pain (75-100mm) on a scale of 0-100mm |
Preop Post op after 1 week, 1month 3 month 6 month
|
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Periapical status after intervention
Временное ограничение: Preop Post op 3 month 6 month
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The periapical status will be assessed by using the periapical index [PAI] scoring system. Each tooth will be assigned to one of the PAI scores for the 5 categories within the scale. PAI less than or equal to 2 would be successful outcome.
|
Preop Post op 3 month 6 month
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Соавторы и исследователи
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Другие идентификационные номера исследования
- 60/24
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .