CGF Partial Pulpotomy Versus Endodontic Treatment

Официальное название

Partial Pulpotomy Usung CGF Versus Endodontic Treatment in Treating Irreversibly Inflamed Mature Peramnent Molars

Обзор

partial pulpotomy of mature molars with irrevesible pulptits using CGF in adolescents

Подробное описание

partial pulpotomy of mature molars with irrevesible pulptits using CGF in adolescents form 12-17 years old versus endodontic treatment with a 2 years follow up

Вмешательства

• Процедура Other treatment
  partial pulpotomy using CGF in irreversibly inflamed mature molars in adolescents
• Процедура Other treatment
  endodontic treatment using guttapercha in irreversibly inflamed molars in adolescents

Первичные конечные точки

• The primary outcome was to compare the cumulative pain responses using modified VAS scores. [Срок оценки: one week]
• Pulpal blood biomarkers [Срок оценки: one week]

Вторичные конечные точки (3)

• clinical follow up [Срок оценки: one week]
• clinical follow up [Срок оценки: one week]
• Radiographic follow up [Срок оценки: 2 years]

Критерии участия

Критерии включения

• Patient-based criteria: Class ASA I or II cooperative adolescents of 11 - 17 years. Based on a 10 cm modified visual analog scale (VAS), only patients who reported a preoperative pain intensity score of ≥ 7, indicative of severe pain were included.

Tooth-based criteria: Presence of occlusal extremely deep carious lesion with pulp exposure of mandibular first permanent molars with closed apices (i.e. class V according to Cvek's stages of root development) with sound contralateral molars to provide a reference for biomarker quantification and pulp sensibility tests. Only teeth diagnosed with symptomatic irreversible pulpitis (SIP) were included. To validate the diagnosis of SIP, the teeth with the teeth diagnosed with symptomatic irreversible pulpitis (SIP) were included. To validate the diagnosis of SIP, the teeth with the following criteria were exclusively included:

• History of sharp, spontaneous, and lingering pain that was precipitated by thermal provocation and lasted mostly for ≥ 30 seconds.
• Early prolonged, intense, and lingering response to cold thermal stimulus and positive response electric pulp test (EPT) at low thresholds.
• Normal color and appearance of the tooth surrounding gingival tissues with no evidence of gingival inflammation, swelling, abnormal tooth mobility, or sinus tract or fistula formation upon visual and palpation inspections.
• Preoperative periapical radiograph with evidence of caries penetrating the entire thickness of the dentin with no isolating radiopaque zone separating the lesion from the pulp indicating extremely deep caries.
• Normal radiographic findings in terms of intact periodontal membrane space

Критерии исключения

Patient-based criteria: Patients with a positive history of the following conditions were excluded:

• Emotional or behavioral problems and those receiving antidepressant drugs.
• Under treatment with antibacterial or anti-inflammatory medicaments for the last four weeks (Akbal Dincer et al., 2020).
• Localized or generalized gingivitis and/or periodontitis with loss of epithelial attachment ≥ 3mm upon probing.
• Poor oral hygiene with dense accumulation of calculus or dental plaque.
• Systemic conditions such as diabetes, bleeding, immunological disorders.

Tooth-based criteria:

• Teeth with abnormal structure or developmental anomalies.
• Persistent hemorrhage from the root canal orifices lasting longer than 10 minutes.
• Loss of coronal structure beyond restorability

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

Египет · 1 центр

• Pediatric and Community Dentistry Department , Faculty of Dentistry , Minia University — Minya

Публикации

• Nawal RR, Yadav S, Duncan HF, Talwar S, Kaushik A, Singh VK, Koner BC. Discriminatory performance of the pulpal inflammatory biomarkers; Interleukin-8 and TNF-alpha in patients with symptoms indicative of reversible and irreversible pulpitis: A diagnostic accuracy study. Int Endod J. 2024 Sep;57(9):1200-1211. doi: 10.1111/iej.14078. Epub 2024 May 4. PMID 38703070
• Sabeti MA, Nikghalb K, Pakzad R, Fouad AF. The Relationship Between Pulpal Diagnostic Conditions and Potential Inflammatory Biomarkers. Int Endod J. 2026 Jan;59(1):23-37. doi: 10.1111/iej.70030. Epub 2025 Sep 9. PMID 40923157
• Karrar RN, Cushley S, Duncan HF, Lundy FT, Abushouk SA, Clarke M, El-Karim IA. Molecular biomarkers for objective assessment of symptomatic pulpitis: A systematic review and meta-analysis. Int Endod J. 2023 Oct;56(10):1160-1177. doi: 10.1111/iej.13950. Epub 2023 Jul 17. PMID 37392154
• Uesrichai N, Nirunsittirat A, Chuveera P, Srisuwan T, Sastraruji T, Chompu-Inwai P. Partial pulpotomy with two bioactive cements in permanent teeth of 6- to 18-year-old patients with signs and symptoms indicative of irreversible pulpitis: a noninferiority randomized controlled trial. Int Endod J. 2019 Jun;52(6):749-759. doi: 10.1111/iej.13071. Epub 2019 Jan 30. PMID 30638262

Идентификаторы

NCT: NCT07417098 · MiniaU pedo dept

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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