Clinical and Radiographic Assessment of Pulpotomy in Diabetic and Non Diabetic individuals with Symptomatic Pulpitis A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- CLINICAL OUTCOMES:
研究概览
简要总结
This randomized clinical trial aims to evaluate and compare the clinical and radiographic outcomes of pulpotomy procedures in controlled diabetic and nondiabetic individuals diagnosed with symptomatic irreversible pulpitis. Participants will be allocated into two parallel groups (diabetic and nondiabetic) and will undergo a standardized pulpotomy treatment using biocompatible materials. Clinical parameters such as pain tenderness mobility along with radiographic findings ( periapical status,internal or extrnal resorption,hard tissue barrier formation), will be assessed at baseline 1month 3 months 6 months and 12 months post-treatment. The study seeks to determine whether systemic diabetic status influences the healing outcome and success of pulpotomy treatment in mature permanent teeth.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- None
入排标准
- 年龄范围
- 20.00 Year(s) 至 45.00 Year(s)(—)
- 性别
- All
入选标准
- •Healthy and controlled diabetics with HbA1c value (5.7 to 7) Premolars and molars diagnosed with symptomatic pulpitis Presence of large carious lesions radiographically Moderate to severe pain with positive pulp sensibility tests Vital pulp tissue visible upon accessing the pulp chamber Hemostasis achieved within 10 minutes after pulpotomy.
排除标准
- •Patients with ASA III,IV,V,VI 2) Pregnant women 3) Necrotic pulp or non-vital teeth 4)Teeth with periapical lesions 5)Presence of internal or external tooth resorption Failure to control bleeding within 10 minutes of the procedure.
结局指标
主要结局
CLINICAL OUTCOMES:
时间窗: 24hours 1week 12weeks 24weeks 48weeks
1 Absence of signs and symptoms of symptomatic pulpitis
时间窗: 24hours 1week 12weeks 24weeks 48weeks
2 absence of swelling or sinus tract
时间窗: 24hours 1week 12weeks 24weeks 48weeks
3 Absence of abnormal tooth mobility
时间窗: 24hours 1week 12weeks 24weeks 48weeks
RADIOGRAPHIC OUTCOMES
时间窗: 24hours 1week 12weeks 24weeks 48weeks
1 No sign of internal or external root resorption
时间窗: 24hours 1week 12weeks 24weeks 48weeks
2 No new periapical pathosis
时间窗: 24hours 1week 12weeks 24weeks 48weeks
3 Formation of hard tissue barrier
时间窗: 24hours 1week 12weeks 24weeks 48weeks
次要结局
未报告次要终点
研究者
Kodipyaka Sushmitha
MNR Dental College and Hospital
