Comparative evaluation of inflammatory biomarkers in gingival crevicular fluid after Mineral Trioxide Aggregate and Biodentine pulpotomy in teeth with Symptomatic Irreversible Pulpitis: An Open label Randomized Controlled Trial.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- primary outcome : evaluate change in inflammatory marker before and after pulpotomy
研究概览
简要总结
SUMMARY
TITLE OF THE STUDY:
“Comparative evaluation of inflammatory biomarkers in gingival crevicular fluid after Mineral Trioxide Aggregate and Biodentine pulpotomy in teeth with Symptomatic Irreversible Pulpitis: A Randomized Controlled Trialâ€.
Traditionally , The clinical diagnosis of pulp status is based on clinical signs and symptoms, the extent of adjacent caries, responses to pulp testing and percussion, and the radiographic presentation of the periapical tissues at the root apex.
However various studies have concluded that there is insufficient evidence to determine whether the symptoms offer accurate information about the extent of pulp inflammation. Also the inflammatory changes in teeth exhibiting these symptoms are frequently limited to the pulp next to carious lesions, while the majority of the pulp tissue remains uninflamed and viable .
As a result its critical diagnosis becomes difficult.
Biological markers in pulp and surrounding tissue like gingival crevicular fluid serves as a diagnostic biomarker for inflammation.
Pulpotomy is being preferred as a minimally invasive treatment over traditional RCT. (sustaining vitality, neurosensory capacity and proprioception , less time consumable , less difficult & less expensive) as it incorporates the use of dental biomaterials ( MTA and Biodentine) that preserves pulpal vitality and encourages healing.
There is lack of evidence in assessment of inflammatory markers in pulpotomy treatment for teeth diagnosed with symptomatic irreversible pulpitis.
Therefore this randomized controlled trial is proposed to asses the changes in inflammatory markers in gingival crevicular fluid after pulpotomy in mature permanent teeth present with diagnosis of SIP.
AIMS AND OBJECTIVES:
AIM:
To compare the changes in the level of inflammatory biomarkers IL-8, TNF-a ,MMP-9 in gingival crevicular fluid (GCF) before & after MTA & BIODENTINE pulpotomy in teeth with symptomatic irreversible pulpitis.
OBJECTIVES:
Primary objective: To asses the changes in the inflammatory markers in gingival crevicular fluid (GCF) before and after MTA and Biodentine Pulpotomy.
Secondary objective:
Determine the 12 months clinical and radiographic outcome after MTA and BIODENTINE pulpotomy in teeth with symptomatic irreversible pulpitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient age 18 -60 years.Non contributory medical history (ASA1),Deep caries extending to pulp chamber.Vital mature first mandibular molar with symptoms of irreversible pulpitis.Tooth with positive response to pulp sensibility testing.
- •Clinical diagnosis of irreversible pulpitis with PAI score≤2.Tooth should be restorable.Tooth with probing pocket depth and mobility should be within normal limits.
排除标准
- •Teeth with immature roots.Teeth with clinical sign of pulp necrosis such as swelling or presence of sinus tract .Teeth with prominent radiolucency in the furcation area, presence of internal or external root resorption, any calcification.Teeth with no evidence of bleeding after communication with pulp chamber.
- •Absence of antagonist tooth.
- •Had taken analgesic in past 3 days or antibiotic in past one month.Tooth with periapical lesion visible on radiograph.
- •Teeth in which hemostasis was not achieved in 10 min.
结局指标
主要结局
primary outcome : evaluate change in inflammatory marker before and after pulpotomy
时间窗: 7 days
次要结局
- secondary Outcome assessment criteria to be performed every 3, 6 and 12 months :(Clinical criteria:)
研究者
Dr Ranjana Hanumant Deshmukh
All India Institute of Medical Sciences ,Nagpur