Treatment Outcomes of Pulpotomy Versus Pulpectomy in Vital Primary Molars Diagnosed With Symptomatic Irreversible Pulpitis: A Non-inferiority Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Post-treatment clinical outcomes based on presence/absence of pain, tenderness, or signs of infection/pathologic mobility
研究概览
简要总结
This randomised controlled trial aims to compare treatment outcomes between pulpotomy and pulpectomy when used to treat vital primary molars diagnosed with symptomatic irreversible pulpitis. Compared to the standard pulpectomy treatment, pulpotomy is a technically simpler procedure, less time consuming, easier for young patients to tolerate, while retaining the proprioceptive sensation of the tooth - all important advantages when treating young children.
详细描述
Background: Pulpectomy continues to be the standard treatment recommendation for management of vital primary molars diagnosed with symptomatic irreversible pulpitis. The recent decade has seen a paradigm shift in the treatment concepts of how vital mature permanent molars diagnosed with irreversible pulpitis can be more conservatively managed using vital pulp therapy techniques like pulpotomy. However, despite emerging evidence indicating similarities between primary and permanent tooth pulp response to dental caries, there is limited research on whether pulpotomy can be similarly used as a definitive treatment modality for vital primary teeth with irreversible pulpitis. This randomised controlled trial (RCT) aims to compare the treatment effectiveness of pulpotomy versus pulpectomy in management of vital primary molars diagnosed with symptomatic irreversible pulpitis over a two-year period.
Methods/Design: This clinical study is a parallel, two-armed, open label, non-inferiority RCT with a 1:1 allocation ratio between the experimental intervention arm (pulpotomy) and the active comparator arm (pulpectomy). Healthy cooperative children, between 4-9 years of age, who have painful primary molars with clinical symptoms typical of irreversible pulpitis will be recruited after obtaining informed consent from their parents/legal guardians. 80 vital primary molars clinically diagnosed with symptomatic irreversible pulpitis will be randomly distributed between the two treatment arms. The primary outcomes that will be assessed are clinical success after one-year and two-years of the trial interventions. The influence of baseline pre-operative variables (age; gender; tooth type; site of caries; pre-operative furcal radiolucency; pre-operative pain intensity) and intra-operative factors (time taken to achieve haemostasis) on treatment outcomes will also be assessed. The secondary outcomes evaluated will be the immediate (24 h and 7 d) post-operative pain relief afforded by the two treatment interventions, and the radiographic success after one-year and two-years of the trial interventions.
Discussion: This trial seeks to provide evidence on whether pulpotomy treatment can be no worse than the standard pulpectomy treatment for the management of symptomatic irreversible pulpitis in vital primary molars.
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
- None
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
- •Healthy (ASA I and II) co-operative children (Frankl Scale + and ++) between the ages of four and nine years.
- •Participants have symptoms typical of irreversible pulpitis in one of the primary molars.
- •The pulp of the affected primary molar is vital.
- •Radicular pulp health is confirmed by attainment of radicular pulp haemostasis within 6 minutes of coronal pulp amputation.
- •The affected primary molars can be restored with full coverage stainless steel crowns.
- •Any physiologic root resorption, if present, is less than ⅓ the root length.
排除标准
- •Clinical examination of affected primary molar reveals signs of pulpal infection (e.g. pathologic tooth mobility, parulis/fistula, or soft tissue swelling).
- •Pre-operative periapical radiograph suggests presence of periapical radiolucency or pathologic root resorption.
- •Visual examination of pulp tissue after deroofing reveals signs of necrosis (e.g. avascular/minimally bleeding pulp tissue or yellowish necrotic areas/purulent exudate).
- •Signs of extensive radicular pulp inflammation i.e., root pulp bleeding continues even after 6-min.
- •Parents not willing to place full coverage crowns post-treatment.
- •Clinical diagnosis of irreversible pulpitis between two adjacent primary molars is not sharply defined.
- •Unable to perform clinical procedure under rubber dam
研究组 & 干预措施
Pulpotomy
Participants diagnosed with symptomatic irreversible pulpitis in vital primary molars will receive the pulpotomy treatment intervention
干预措施: Pulpotomy (Procedure)
Pulpectomy
Participants diagnosed with symptomatic irreversible pulpitis in vital primary molars will receive the pulpectomy treatment intervention.
干预措施: Pulpectomy (Procedure)
结局指标
主要结局
Post-treatment clinical outcomes based on presence/absence of pain, tenderness, or signs of infection/pathologic mobility
时间窗: 6 months; 12 months; 24 months
Clinical outcome success will be determined at 6-, 12-, and 24-months based on the treated tooth meeting all the below criteria: (i) Treated tooth is not associated with any pain or discomfort; (ii) Treated tooth is not associated with tenderness on percussion or palpation; (iii) Treated tooth is not associated with any swelling, parulis, or fistula; (iv) Treated tooth is not associated with any pathological mobility
次要结局
- Post-treatment radiographic outcomes based on presence/absence of pathologic root resorption, new furcal or periapical lesions, or size change of any pre-treatment furcal rarefaction(6 months; 12 months; 24 months)
- Immediate post-treatment pain relief(24 hours; 7 day)
研究者
Nebu Philip
Assistant Professor
Qatar University