Inflammatory Biomarker Based Substantiation of Evidence for Performance of Vital Pulp Therapy asPotential Alternative to Endodontic Treatment using Quantitative light-induced Fluorescence Guided Caries Removal for Management of Symptomatic Carious Mature Teeth (Extremely Deep/Deep Carious Lesion)
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Post operative pain
研究概览
简要总结
Dental caries affects nearly 3.5 billion people globally. As most patients report in advanced stage, 70% of them need root canal treatment (RCT) for caries management. However, RCT is a destructive procedure resulting in complete removal of vital tissues of the tooth. Vital Pulp Therapy (VPT) has merged as an economical and conservative alternative to RCT. However, at present the *main deterrent for VPT to be considered as first line of treatment for carious teeth is lack of high-quality evidence and objective criteria for case selection.*Hence, the aim of this prospective clinical study is to evaluate the outcome of vital pulp therapy procedure in symptomatic cariously exposed posterior teeth with Quantitative Light-induced Fluorescence (QLF) assisted caries removal and correlate the level of locally expressed inflammatory biomarkers in pulpal blood with the treatment outcome. The proposed study shall be conducted in the Department of Conservative Dentistry & Endodontics, at Maulana Azad Institute of Dental Sciences, New Delhi on 120 patients referred to the department for the management of their symptomatic carious permanent molar teeth. Informed consent will be obtained from all patients prior to treatment followed by taking history. Patient will be randomly allocated to QLF or Non QLF group. All the treatment procedure will be done by experienced endodontists under dental operating microscope using enhance treatment protocol recommended by European society of Endodontists (ESE). The cavity will be prepared using a sterile high-speed round bur, whereas carious removal will be performed using a slow-speed round bur and a spoon excavator. After caries removal, prepared cavity will be scanned with QLF in QLF group. The infected dentin indicated by QLF analysis will be further removed. Complete removal of infected dentin will be ensured by scanning prepared cavity again before pulpal exposure. In both the Experimental groups, partial pulpotomy will be attempted first. If bleeding cannot be arrested even after 10 minute using 2.5-3% Sodium hypochlorite, full pulpotomy will be performed. Patient will be regularly followed up for post operative pain assessment (1,3,7,14 days), clinical and radiographic treatment outcome (Minimum 1 year follow up).
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Clinical inclusion criteria: The age of the patient should be 18 or above Patient should have non-contributory medical history Symptomatic permanent mature posterior tooth with deep or extremely deep Class I/II caries with symptoms indicative of irreversible pulpitis History of Moderate to severe pain History of spontaneous pain and/or nocturnal pain which aggravates on lying down.
- •Patient reporting with spontaneous pain and/or with sharp and lingering pain upon cold testing using Endo-Ice and early exaggerated response with electric pulp testing.
- •A restorable tooth with probing pocket depth (<3mm) and mobility within normal limits.
- •Complete caries removal will result in pulpal exposure.
- •Pulpal bleeding can be arrested with 2.5-3% NaOCl irrigation within 10 minutes after inflamed pulp amputation.
- •Radiological inclusion criteria: Deep or Extremely deep caries Absence of periapical or furcation changes in the radiograph.
排除标准
- •Clinical exclusion criteria: Tooth having unexposed pulp after complete caries removal.
- •Tooth exhibiting uncontrolled pulpal haemorrhage during the procedure lasting more than 10 minutes.
- •Exposed pulp tissue appearing necrotic, judged by absence of bleeding or presence of pale necrotic pulp tissue.
- •Tooth showing negative response to cold testing or presence of sinus tract or swelling.
- •Radiological exclusion criteria: Prominent radiolucency at the furcation or periapical regions Presence of apical resorption Presence of internal or pathologic external root resorption, calcification, or pulp canal obliteration.
结局指标
主要结局
Post operative pain
时间窗: 12 months
Clinical and Radiographic success of Vital pulp Treatment at minimum one year follow up
时间窗: 12 months
correlation between Inflammatory markers and pre operative diagnosis
时间窗: 12 months
次要结局
- Post operative pain assessed using visual analog scale(i,3,7,14 days)
- Association between level of inflammatory mediators in Pulpal Blood and treatment outcome(12 months)
- Correlation between level of inflammatory mediators in pulpal blood and preoperative diagnosis(12 months)
- Effect of Vital pulp treatment on Oral Health Related Quality of Life(12 months)