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临床试验/CTRI/2024/02/062482
CTRI/2024/02/062482已完成4 期

Effect of healing outcomes of pulpotomy compared with root canal treatment in patients diagnosed with symptomatic irreversible pulpitis: A randomized controlled trial

MGM Dental College and Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年2月15日最近更新:

试验速览

阶段
4 期
状态
已完成
入组人数
60
试验地点
1
主要终点
healing outcomes measured in terms of pain

研究概览

简要总结

The most common oral health issue is untreated dental caries in permanent teeth. Dental caries left untreated can result in the spread of bacteria and their toxins entering the dental pulp, inflaming it to varied degrees. In previous studies it has been observed that the underlying pulp continued to be free of inflammation even in advanced cases of inflammation with irreversible pulpitis, with only isolated portions of pulp in the coronal aspect experiencing bacterial invasion and micro abscesses. After excavation of infected coronal pulp tissue followed by restoration with biomimetic materials like MTA may prevent the further progress of infection. Thus, the vitality of the radicular pulp can be maintained. The Purpose of the current randomized controlled trial will be to assess the healing outcomes clinically and radiographically in adult patients diagnosed with symptomatic irreversible pulpitis. This is a prospective single blind (observer blind) open label trial. The post-operative pain levels and healing outcomes between Pulpotomy and RCT group will be assessed at baseline, 6 hours, 24 hours and 7 days post-operative time intervals and the data will be statistically analyzed using unpaired t-test (for parametric data) or Mann-Whitney U test (for non-parametric). Within group comparison for the post-operative pain levels between Pulpotomy and RCT group will be assessed at baseline, 6 hours, 24 hours and 7 days post- operative time intervals using repeated measure ANOVA and Tukey’s post-hoc (for parametric data) or Kruskal–Wallis ANOVA and Dunn’s post-hoc (for non-parametric).

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • patients who accept goals and requirements and are willing to participate in study.
  • All patients are in good health, based on their written histories and oral interviews.
  • Patients with moderate to severe pain involving one tooth.
  • Vital teeth with irreversible pulpitis with or without apical periodontitis.
  • Patients with PAI index score of 1 Thermal and electric pulp test yielded a positive response.
  • teeth with favorable condition for rubber dam isolation.
  • Teeth with fully developed apex.
  • Teeth with healthy periodontium with periodontal probing depth less than 3 mm.
  • Permanent human teeth.
  • Intact teeth with no cracks or defects.
  • Roots with patent canals.

排除标准

  • Patients who will not accept the study freely.
  • Patients who do not provide authorization for participation.
  • Patients below 18 years and above 50 years of age.
  • Pregnant women and nursing mothers.
  • Patients with non-vital teeth Patients with acute or chronic dentoalveolar abscess or cellulitis.
  • Patients whose tooth has been accessed previously or endodontically treated.
  • Patients with inflamed pulp in which bleeding could not be controlled within 10 minutes.
  • Patients who have taken medications which, in the opinion of the investigator, could interfere with the conduct of the study (example corticosteroids, antibiotics and analgesics in the past month).
  • Patients with known systemic disorders or immunocompromised conditions (example diabetes, AIDS) Patients with PAI index score greater than 1 Patients with an intraoral and extraoral sinus tract.
  • Patients who are having teeth with multiple canals, bifurcation and trifurcation of canals, canal aberration, calcified canals, open apex, root resorption, presence of root caries and multirooted teeth.
  • Teeth with aggressive periodontitis and grade III mobility, periodontal probing depth greater than 3mm.
  • Severe labially or lingually malposition teeth in which obtaining straight-line access will be difficult.
  • Teeth are indicated for intentional endodontic therapy for prosthetic reasons.

结局指标

主要结局

healing outcomes measured in terms of pain

时间窗: 6, 24 hours, 7 days, 3, 6, 9, 12 months

次要结局

  • clinical outcomes in terms of signs and symptoms(6, 24 hours, 7 days, 3, 6, 9, 12 months)
  • radiographic outcome in terms of periapical index score(6, 24 hours, 7 days, 3, 6, 9, 12 months)

研究者

申办方类型
Other [Private Dental College]
责任方
Principal Investigator
主要研究者

Dr Sumanthini M V

MGM Dental College and Hospital

研究点 (1)

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