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临床试验/CTRI/2024/10/075830
CTRI/2024/10/075830尚未招募Phase 3 4

Comparative evaluation of coronal pulpotomy and partial radicular pulpotomy in vital mature permanent molars with irreversible pulpitis and/or apical periodontitis using chitosan and prf(platelet rich fibrin)-A Randomized controlled trial

Faculty of Dental Sciences IMS BHU1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2024年11月4日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
48
试验地点
1
主要终点
Decrease in visual analogue scale of pain.

研究概览

简要总结

Permanent teeth diagnosed with “irreversible pulpitis” have long been implied to have an irreversibly damaged dental pulp that is beyond repair and warranting root canal treatment. However, newer clinical approaches such as pulpotomy, a minimally invasive and biologically based procedure have re-emerged to manage teeth with pulpitis. Recent position statements from the American Association of Endodontists and the European Society of Endodontology (ESE) have concluded that ‘pre-treatment diagnosis of irreversible pulpitis is not necessarily an indication for pulpectomy’, heralding a new era for minimally invasive VPT in mature permanent teeth. In cases with irreversible pulpitis, the morphological changes indicating inflammation or necrosis were principally occurring in the coronal pulp whilst the radicular pulp was viable. This suggests that the radicular pulp could potentially be retained when a pulpotomy procedure is performed, thus preventing the need for a pulpectomy. This less invasive treatment approach called the Endolight concept was used by W.J. Wolters to propose a new classification for clinical pulp diagnosis.

According to this new classification, in cases of severe pulpitis (severe spontaneous pain and clear pain reaction to warmth and cold stimuli, often, sharp to dull throbbing pain, sensitive to touch and percussion) the treatment opted is full pulpotomy, If there is no pro-longed bleeding of pulp stumps in the orifices of the canals and if one or more of the pulp stumps keeps bleeding after rinsing with 2 mL 2% NaOCl, a superficial pulpotomy can be carried out, whereby more inflamed tissue is removed from the canal up to 3–4 mm from the radiographic apex (also known as radicular pulpotomy). Thus, indicating the need to disregard the closely held belief that a vital mature permanent tooth diagnosed with irreversible pulpitis will require root canal treatment for long-term preservation of the tooth rather than the less invasive vital pulp therapy (VPT).

Here in this study we would be using CHITOSAN and PRF as scaffold.

Scaffolds are three-dimensional (3D) porous solid biomaterials which Provide a spatially correct position of cell location which helps in tissue regeneration.

PLATELET RICH FIBRIN (PRF) is second-generation platelet concentrate named as Choukroun’s PRF after its inventor. PRF is biological and Ideal biomaterial for pulp-dentin complex regeneration. The procedure consists of drawing blood which is collected into test tubes without any anticoagulant and is centrifuged instantaneously. A tabletop centrifuge can be used for 10 min at 3000 rpm or for 12 min at 2700 rpm. It contains multitude of growth factors such as PDGF, TGF β1, and IGF. It prevents the early encroachment of undesired cells, thereby acts as a viable barrier between desired and undesired cells and accelerates wound closure with mucosal healing due to fibrin bandage and growth factor release.

CHITOSAN is synthetic biomaterial.  It is produced commercially by deacetylation of chitin, which is the structural element in the exoskeleton of crustaceans (such as crabs and shrimp) and cell walls of fungi. It is nontoxic, easily bioabsorbable, shows antibacterial activity, has gel forming ability, increases alkaline phosphatase activity, shows fibroblast and odontoblastic proliferation. It is a porous scaffold that can be molded into any shape and its hydrophilic property enhances cell attachment and proliferation.

 Therefore, based on this data ,A study has been planned  comparing “ CORONAL PULPOTOMY AND PARTIAL RADICULAR PULPOTOMY IN VITAL MATURE PERMANENT MOLAR WITH IRREVERSIBLE PULPITIS AND/OR APICAL PERIODONTITIS USING CHITOSAN AND PRF”- A RANDOMISED CONTROLLED TRIAL.

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
15.00 Year(s) 至 35.00 Year(s)(—)
性别
All

入选标准

  • 1.Mature vital permanent molar 2.Possibly sensitive to percussion.
  • 3.Strong and prolonged reaction to thermal testing, which can last for minutes.
  • 4.Spontaneous dull pain that can be more or less suppressed by pain medication clinical diagnosis of irreversible pulpitis with/without periapical rarefaction.
  • 5.ORSTAVIK’S PAI (periapical index) and CBCT PAI score ≤
  • 6.No signs of pulpal necrosis including sinus tract or swelling.

排除标准

  • 1.Non restorable teeth.
  • 2.Negative response to thermal testing, the presence of sinus tract or swelling.
  • 3.Bleeding could not be controlled after pulpotomy in 5 minutes.
  • 4.Insufficient bleeding after pulp exposure, the pulp is judged necrotic or partially necrotic 5.Medically compromised patient.

结局指标

主要结局

Decrease in visual analogue scale of pain.

时间窗: 1st,2nd,7th day

次要结局

  • No evidence of progression of periapical pathological finding in radiograph.(3 ,6 ,12 months)
  • Resolution of periapical pathology after treatment.(3 ,6 ,12 months)

研究者

发起方
Faculty of Dental Sciences IMS BHU
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Neelam Mittal

Faculty of Dental Sciences IMS BHU

研究点 (1)

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