Clinical and Radiographic Success of MTA Full Pulpotomy VS MTA Partial Pulpotomy; a Split-mouth Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Clinical success
研究概览
简要总结
Background: Full pulpotomy has been the treatment of choice for normal or reversibly inflamed exposed pulps in primary molars. However, this approach has its own disadvantages and may be simplified down to a more conservative type of pulpotomies which is the "partial pulpotomy".
Though the literature is still lacking high quality studies on partial pulpotomy in primary molars.
Since MTA has demonstrated the highest success in the literature in comparison to other pulpotomy agents, it is going to be the choice in this trial. Aims: This study aims to investigate the success of partial vs full pulpotomies using MTA in vital primary molars without irreversible pulpitis. Methods: This is an RCT with a split-mouth design, comparing the radiographic and clinical changes of full vs partial MTA-pulpotomies over a one-year period in primary molars. The study will involve 25 healthy children, aged 4-8 years, who are attending JUST postgraduate clinics for dental treatment. Children with pair-matched primary molars that are present with advanced caries exposing the pulp or requiring pulpotomy will be enrolled. Teeth will be randomly assigned to either full or partial pulpotomy. Both procedures will be conducted under LA and rubber dam isolation.
The whole coronal pulp is going to be removed in full pulpotomy compared to 1-3 mm of the coronal pulp in partial pulpotomy. For both procedures, MTA will be placed, then the tooth will be restored with IRM, with the SSC as the final restoration. Afterwards, participants are going to be followed up clinically every 3 months, and radiographically every 6 months over the study period.
Expected results: partial pulpotomy is expected to be a viable alternative to the full pulpotomy, Partial pulpotomy might be recommended as a treatment option since it is more conservative to the pulp and involves less damage to the hard tissues rendering the tooth easier to restore. More importantly, the procedure is assumed to be less painful and more acceptable to young children with limited cooperation
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children aged 4-8 years
- •Medically fit or with mild systemic disease (ASA I or II),
- •Able to attend all follow-up appointments
- •Children with deeply carious pair-matched primary molars with normal or reversibly inflamed pulp that are indicated for pulpotomy (with almost radiographic caries exposure of the pulp).
- •Children who are willing to take part in the study
- •Children with valid parental consent
排除标准
- •History of lingering or nocturnal pain, any clinical sign of pulp degeneration such as pathological mobility, tenderness to percussion/palpation, presence of fistulae or odontogenic facial swelling.
- •The presence of radiologic signs of pulp infection/necrosis such as pathological external root resorption, internal resorption, bifurcation of apical radiolucency.
- •Teeth with developmental dental anomalies, unrestorable crown or with advanced physiologic root resorption (> 1/3).
- •Children with known allergy to any of the materials or medicaments used in the study.
结局指标
主要结局
Clinical success
时间窗: 12 months
Clinical evaluation will include the following parameters: pain, mobility, tenderness to percussion, periodontal pocket formation, gingival inflammation, and sinus tract formation. Each tooth was scored from 1 to 4 according to the criteria by Zurn and Seale 2008
Radiographic Success
时间窗: 12 months
Radiographic evaluation will include the following parameters: periapical or furcal radiolucency, internal resorption, and external resorption. Each tooth was scored from 1 to 4 according to the criteria by Zurn and Seale 2008
次要结局
未报告次要终点