Clinical and Radiographic Evaluation of Partial Pulpotomy Versus Complete Pulpotomy in Vital Pulp Therapy in Primary Molars Using NeoPUTTY™ (MTA): Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Mobility
研究概览
简要总结
Evaluating the clinical and radiographic success of partial pulpotomy compared to complete pulpotomy in vital primary second molars with reversible pulpitis using NeoPUTTY™ (MTA).
详细描述
Children with symptoms of reversible pulpitis in their second primary molar will be chosen to be enrolled in the study, and then randomly allocated into two groups. One group will undergo partial pulpotomy and the other group complete pulpotomy and followed up for 12 months. The blinding of the operator is not possible due to the nature of the technique used. Trial participants, outcome assessors and statistician will be blinded.
- Informed consent from participating children's parents.
- Baseline records photographs, percussion test, periapical radiograph and personal data collection.
- Diagnostic chart with personal, medical and dental history will be filled.
- Allocation (concealed by withdrawing a sealed opaque envelope containing Four-folded numbered papers containing the type of vital pulp therapy technique that will be used then writing the patient's name and I.D. on it and will be opened after removing the carious lesion).
- Clinical examination will be performed to assess the clinical inclusion criteria. (Pulpal and periapical diagnoses are established after clinical examination).
- Preoperative and Postoperative photographs will be taken.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients:
- •Aged 4-7 years, in good general health and medically within normal.
- •Restorable mandibular second primary molars.
- •History of reversible pulpitis.
- •Preoperative radiograph:
- •Absence of periapical or inter-radicular radiolucency.
- •Absence of widening of periodontal ligaments (PDL) space.
- •Absence of internal or external root resorption.
排除标准
- •Patients:
- •With systemic disorders.
- •Physical or mental disabilities.
- •Unable to attend follow-up visits.
- •Refusal of Participation.
- •Refusal to sign the informed consent.
- •Previously accessed teeth.
- •Mobile mandibular second primary molar.
- •Swelling in the vestibule or on palpation.
- •Pain on percussion.
结局指标
主要结局
Mobility
时间窗: 3, 6, 9, 12 months
Assesment of pathological mobility using mobility test.
Swelling/ Fistula
时间窗: 3, 6, 9, 12 months
Assessment of swelling and fistula through visual examination.
Postoperative pain
时间窗: one week postoperative
Postoperative pain assessment through Visual Analog Scale (the lower the value the better).
次要结局
- Radiographic success(0, 6, 12 months)
研究者
Yara Ayman
Internal resident of Pediatric Dentistry and Public Health, Cairo University
Cairo University