Partial Pulpotomy Usung CGF Versus Endodontic Treatment in Treating Irreversibly Inflamed Mature Peramnent Molars
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The primary outcome was to compare the cumulative pain responses using modified VAS scores.
研究概览
简要总结
partial pulpotomy of mature molars with irrevesible pulptits using CGF in adolescents
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 11 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
CGF partial pulpotomy
partial pulpotomy using CGF in mature molars diagnosed with irreversible pulpitis
干预措施: Other treatment (Procedure)
Endodontic treatment
Endodontic treatment of mature molars with irreversible pulpitits
干预措施: Other treatment (Procedure)
结局指标
主要结局
The primary outcome was to compare the cumulative pain responses using modified VAS scores.
时间窗: one week
The primary outcome was to compare the cumulative pain responses using modified VAS scores which has a scale from 0 -10 after partial pulpotomy using CGF versus Endodontic treatment throughout one week of follow-up period.
Pulpal blood biomarkers
时间窗: one week
Measuring Biomarker levels via quantifying NKA, SP, IL-8, and MMP-8 in pg/ml blood after partial pulpotomy using CGF versus Endodontic treatment throughout one week of follow-up period
次要结局
- clinical follow up(one week)
- Radiographic follow up(2 years)
研究者
Mostafa Kamel Mohamed abdallah
Dr
Minia University