A STUDY TO ASSESS THE OUTCOME OF COMBINATION OF NON-SURGICAL ENDODONTIC THERAPY AND VITAL PULP THERAPY IN COMPARISON TO FULL PULPOTOMY PERFORMED IN MATURE PERMANENT MANDIBULAR MOLAR TEETH WITH SYMPTOMATIC IRREVERSIBLE PULPITIS AND PERIAPICAL RAREFACTION- A RANDOMIZED CONTROLLED TRIAL
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- a)Full pulpotomy
研究概览
简要总结
| The conventional treatment for management of teeth with symptomatic irreversible pulpitis is non-surgical endodontic therapy (NSET). This was based on the premise that entire pulp would degenerate in totality (Strangulation theory) (3). However, due to enhanced understanding of the pulp pathophysiology, the notion has changed and the current theory put forwards the concept that pulpal changes occur in stages with the degeneration occurring from coronal to radicular pulp denoting that vital pulp tissue is expected in the radicular part in teeth with irreversible pulpitis (3). Hence there has been a paradigm shift in the management of teeth with symptomatic irreversible pulpitis. Full pulpotomy is being advocated. Hemorrhage control is an important factor in determining whether the inflammation has progressed into radicular pulp. If pulpal bleeding continues for more than 10 minutes the treatment of choice is pulpectomy. Several agents are being used for hemorrhage control in pulpotomy. The most commonly used is 2.5% NaOCl.But it is toxic to the pulp &ineffective in deeper pulpal tissues (55). Cryotherapy has hemostatic, anti-inflammatory &analgesic properties. Cryotherapy is a non toxic and cost effective method for the patients. There is no study available in the literature that has investigated the effect of cryotherapy on the treatment outcome of full pulpotomy performed in mature permanent mandibular molar teeth with symptomatic irreversible pulpitis. This study is done to evaluate the effect of cryotherapy on the treatment outcome of full pulpotomy performed in mature permanent mandibular molar teeth with symptomatic irreversible pulpitis.In this study we are using an indigenous cryotherapy delivery unit which maintains the delivery of cold saline constantly at 2.50C for 10 minutes to improve the effect of the treatment. |
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 15.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •â€¢Healthy patient of either gender between 18-45 years of age group.
- •â€¢Mandibular molar teeth with definitive clinical diagnosis of irreversible pulpitis with periapical involvement (PAI score ≥ 3) in either of the roots.
- •â€¢Positive response to either cold or EPT testing.
- •â€¢The tooth is restorable.
- •â€¢Probing pocket depth and mobility are within normal limits.
- •â€¢Cone Beam Computed Tomography records of the patient.
- •Periapical lesion with PAI score ≥ 1 on CBCT will be taken.
排除标准
- •â€¢Teeth with definitive clinical diagnosis of irreversible Pulpitis which are not associated with periapical rarefaction.
结局指标
主要结局
a)Full pulpotomy
时间窗: Day zero:- Inta-oral periapical radiograph and Cone beam computed tomography | At six month follow-up:- Intra-oral periapical radiograph | At Twelve month follow-up :- | Intra-oral periapical radiograph and Cone beam computed tomography
b)Combination of non-surgical endodontic therapy and vital pulp therapy
时间窗: Day zero:- Inta-oral periapical radiograph and Cone beam computed tomography | At six month follow-up:- Intra-oral periapical radiograph | At Twelve month follow-up :- | Intra-oral periapical radiograph and Cone beam computed tomography
Clinical evaluation as well as radiographic evaluation ( including Intra oral peri apical radiograph and Cone beam computed tomography) were done to evaluate for periapical healing
时间窗: Day zero:- Inta-oral periapical radiograph and Cone beam computed tomography | At six month follow-up:- Intra-oral periapical radiograph | At Twelve month follow-up :- | Intra-oral periapical radiograph and Cone beam computed tomography
次要结局
- healing of periapical lesion(1 year)