Comparative Evaluation of Direct Pulp Capping Between Deep and Extremely Deep Caries in Mature Permanent Mandibular Molars .

Официальное название

Comparative Evaluation of Direct Pulp Capping Between Deep and Extremely Deep Caries in Mature Permanent Mandibular Molars With Reversible Pulpitis: A Prospective Study

Обзор

The aim of the study is to compare the clinical and radiographic outcomes of direct pulp capping for deep and extremely deep caries in mature permanent mandibular molars with reversible pulpitis. Primary objective of the study is to evaluate the clinical and radiographic success of direct pulp capping for deep and extremely deep caries in mature permanent mandibular molars with reversible pulpitis. Secondary objective of the study is to evaluate and compare postoperative pain following direct pulp capping for deep and extremely deep caries in mature permanent mandibular molars with reversible pulpitis. Subjects of age group 18 - 40 yrs will be included and divided into two groups 1) Permanent mature molars with deep carious lesion 2) Permanent mature molars with extremely deep carious lesion.

Подробное описание

TITLE-Comparative evaluation of direct pulp capping between deep and extremely deep caries in mature permanent mandibular molars with reversible pulpitis. PICO P (Population) -Mature permanent mandibular molars with clinical signs of reversible pulpitis. I (Intervention) - Direct pulp capping in teeth with extremely deep carious lesion. C (Comparison) - Direct pulp capping in teeth with deep carious lesion. O (Outcome) - 1. Assessment of clinical success at 7 days, 6 months, 12 months and radiographic success at 6 and 12 months of follow up. To assess pain experience at preoperative and post operatively at 24 hours intervals for one week. Direct pulp capping is considered as the most conservative procedure to treat mechanically or traumatically exposed pulp. In this procedure, biomaterial is directly applied on the exposed pulp. According to depth of caries, carious lesion has been classified as deep caries (reaching inner quarter of dentine) and extremely deep caries (extending through entire dentine thickness). Various studies on direct pulp capping in deep carious lesions with reversible pulpitis have reported success rates ranging from 77.3% to 100%. A prospective study by demonstrated a 95.2% success rate for direct pulp capping with extremely deep carious lesions and reversible pulpitis in young individuals. A randomized clinical trial , which included both deep and extremely deep carious lesions, reported a direct pulp capping success rate of 81.3%. A recent systematic review and meta-analysis highlighted that the depth of caries penetration is a critical factor that need to be considered when evaluating the outcomes of direct pulp capping in cariously exposed pulps. Currently, there is a lack of clinical trials comparing the effectiveness of direct pulp capping in cases of deep and extremely deep caries presenting with reversible pulpitis. Hence, the present trial is designed to assess differences in clinical and radiographic outcomes of direct pulp capping between deep and extremely deep carious lesions in mature permanent teeth diagnosed with reversible pulpitis.

Вмешательства

• Процедура Direct pulp capping in extremely deep carious lesion.
  After pulp exposure, pulp 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 every 2 minutes till. Hemostasis will be achieved with 3% NaOCl .The time used to control bleeding will be recorded for each tooth. Teeth with excessive uncontrollable bleeding even after 8 mins will be excluded from the study; however, definite treatment will be provided to the patient. Size of exposure will be measured. After t
• Процедура Direct pulp capping in deep carious lesion.
  After pulp exposure, pulp 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 every 2 minutes. Hemostasis will be achieved with 3% NaOCl . The time used to control bleeding will be recorded for each tooth. Teeth with excessive uncontrollable bleeding even after 8 mins will be excluded from the study; however, definite treatment will be provided to the patient. Size of exposure will be measured. After that,

Первичные конечные точки

• Success rate at 12 months [Срок оценки: 12 months]

Вторичные конечные точки (1)

• Postoperative pain [Срок оценки: Baseline and at 24 hours, Day 1, Day 2, Day 3, Day 4, Day 5, Day 6 and Day 7 after the treatment]

Критерии участия

Критерии включения

• The patient should be 18-40 years of age.
• Patients with deep and extremely deep caries in permanent mandibular molars.
• Deep caries lesion -Reaching the inner quarter of dentine on radiograph
• Extremely deep caries lesion - Caries penetrating the entire thickness of dentin on radiograph.
• Reversible pulpitis will be diagnosed clinically based on discomfort experienced by the participant when a stimulus such as cold or sweet is applied and goes away within a couple of seconds following removal of stimulus, with no significant radiographic changes in the periapical region of the suspect tooth and pain experienced is not spontaneous.
• Tooth should give positive response to pulp sensibility testing.
• Bleeding can be controlled with in 8 minutes.
• Radiographic finding of periapical index (PAI) score ≤2.
• Healthy periodontium (probing pocket depth ≤3 mm and mobility within normal limit).

Критерии исключения

• Teeth with immature roots.
• Internal/external resorption.
• Patient experience spontaneous pain.
• Negative response to vitality testing
• No pulp exposure after complete caries excavation.
• Signs of pulpal necrosis, insufficient bleeding after pulp exposure, sinus tract, swelling.
• Bleeding could not be controlled in 8 minutes.
• Pregnant women
• Contributory medical history (alcoholism, smokers, diabetic, hypertension, drug dependency, Heart or valve disease, hepatitis, herpes, immunodeficiency diseases , infectious diseases, kidney or liver, migraine)

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Индия · 1 центр

• PGIDS , Rohtak — Rohtak

Идентификаторы

NCT: NCT07696702 · Vineeta

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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