Comparative evaluation of non-instrumentation pulp therapy using calcium silicate-based cements versus conventional method for irreversible pulpitis in deciduous molars: a randomized clinical study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 1. To assess the clinical success of the treatment at the follow up visit on 1, 3, 6 months
研究概览
简要总结
American Association of Endodontists (AAE) Consensus Conference Recommended Diagnostic Terminology defines irreversible pulpitis as a clinical diagnosis based on subjective and objective findings indicating that the vital inflamed pulp is incapable of healing. Pulpitis can be managed with different treatment options such as direct pulp capping, pulpotomy, or root canal treatment.
The primary goal of pulp therapy is to maintain the integrity and health of the teeth and their supporting tissues while maintaining the vitality of the pulp of a tooth affected by caries, traumatic injury, or other causes. A pulpectomy is indicated in a primary tooth with irreversible pulpitis or necrosis or a tooth treatment planned for pulpotomy in which the radicular pulp exhibits clinical signs of irreversible pulpitis (eg, excessive hemorrhage that is not controlled with a damp cotton pellet applied for several minutes) or pulp necrosis (eg, suppration, purulence). The roots should exhibit minimal or no resorption.Pulpectomy continues to be the standard treatment recommendation for management of vital primary molars diagnosed with symptomatic irreversible pulpitis.
A pulpotomy is performed in a primary tooth with extensive caries but without evidence of radicular pathology when caries removal results in a carious or mechanical pulp exposure.The coronal pulp is amputed whereas the remaining vital radicular pulp tissue surface is treated with a long-term clinically successful medicament such as Buckley’s Solution of formocresol or ferric sulfate.
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. The ribbon-like torturous root canal anatomy in primary molars makes pulpectomy a difficult procedure for general dentists to perform, often requires a child in pain to be referred to a specialist paediatric dentist for definitive treatment. Pulpotomy has gained popularity as an alternative treatment option to pulpectomy due to its advantages, such as reduced chair time, lower cost, and better preservation of tooth structure.
Due to the limited number of studies and clinical trials evaluating pulpotomy for irreversible pulpitis in primary molars, this study will be undertaken to explore its potential as a viable treatment option.
The null hypothesis is that there will be no significant difference in treatment outcomes of the non-instrumentation intervention pulp therapy and conventional pulpectomy treatment for deciduous molar diagnosed with irreversible pulpitis
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 5.00 Year(s) 至 9.00 Year(s)(—)
- 性别
- All
入选标准
- •Children belonging to age group 5-9 years.
- •Frankl’s scale positive and definitely positive
- •Symptoms typical of irreversible pulpitis i.e., spontaneous unprovoked pain lasting few seconds to several hours in the days before the dental visit or pain that is exacerbated by hot and/or cold stimuli with the pain lingering even after removal of stimuli
- •No clinical symptom or evidence of periapical or furcal radiolucency
- •Restorable teeth
- •Children who agreed to participate and also obtained written consent from their parents/guardians.
排除标准
- •Children suffering from any mental or systemic illness
- •Children with frankl’s scale negative and definitely negative
- •Children with dental emergencies, such as trauma.
- •Clinical examination reveals signs of pulpal infection i.e., pathologic tooth mobility, parulis/fistula, or soft tissue swelling
- •Preoperative periapical radiograph suggests presence of furcal radiolucency more than half the furcation to periapical area
- •Patients/ parents/ legal guardians who refuse to give consent.
结局指标
主要结局
1. To assess the clinical success of the treatment at the follow up visit on 1, 3, 6 months
时间窗: 0-pre treatment | 1-immediate post treatment | 2-after 1 month of treatment | 3-after 3 months of treatment | 4-after 6 months of treatment
2. To assess radiographical success of the treatment at the follow up visit on 1, 3, 6 months
时间窗: 0-pre treatment | 1-immediate post treatment | 2-after 1 month of treatment | 3-after 3 months of treatment | 4-after 6 months of treatment
3. To assess the efficacy of calcium silicate based cement and standard pulpectomy obturating material in deciduous molars diagnosed with irreversible pulpitis
时间窗: 0-pre treatment | 1-immediate post treatment | 2-after 1 month of treatment | 3-after 3 months of treatment | 4-after 6 months of treatment
次要结局
- • To evaluate pain post operatively after 3 days and 7 days of intervention by Wong Baker Faces pain scale(0-pre treatment wong baker scale)
研究者
Dr swasti joshi
Karnavati School of Dentistry
