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临床试验/NCT07302438
NCT07302438尚未招募不适用

Comparative Evaluation of Calcium Silicate-doped Treated Dentin Matrix and Mineral Trioxide Aggregate as Miniature Pulpotomy Biomaterials in Deep Carious Lesions: a Parallel, Double-blind, Randomised Clinical Trial

All India Institute of Medical Sciences1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2026年4月25日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
56
试验地点
1
主要终点
Pulp vitality

研究概览

简要总结

AIM:

To compare the efficacy of a Novel calcium silicate doped treated dentin matrix and Mineral Trioxide aggregate as biomaterials for miniature pulpotomy.

OBJECTIVES:

Primary objective:

To evaluate the efficacy of calcium silicate-doped human-treated dentin matrix (CaSi+hTDM) compared to Mineral Trioxide Aggregate (MTA) in maintaining pulp vitality using cold testing following Miniature Pulpotomy (MP) in deep and extremely deep carious lesions with reversible pulpitis in 14- to 35-year-old patients reporting to Department of Dentistry, AIIMS Nagpur.

Secondary objectives:

  1. To evaluate patient-reported outcomes such as pain, swelling, sinus tract etc. post-operatively.
  2. To determine the clinical success rates of both materials by assessing the Periapical index of healing over a 6 months follow-up period.

NULL HYPOTHESIS:

The null hypothesis (H0) is that there is no difference between CaSi+hTDM and MTA in maintaining pulp vitality when used as a Miniature Pulpotomy (MP) biomaterial in carious lesions.

详细描述

1 INTRODUCTION The loss of tooth structure significantly affects the quality of life for patients. This loss occurs due to decay and other non-carious causes. The resulting inadequate aesthetics and impaired function affects even the psychological wellbeing of the patient. Conventional root canal therapy alongside a quality coronal restoration is widely regarded as the standard treatment for this issue. Yet, traditional treatment approaches consistently present challenges such as significant periradicular dentin loss and the risk of reinfection resulting from a compromised coronal seal. Ideally reestablishment of the lost tissue to their pre-disease level should be the goal of these treatment strategies. Regeneration of the dentin-pulp complex and revitalization of the tooth as well as replacement of lost dentin by newly formed dentin should be ultimate objectives of these treatment strategies.

Caries is a biofilm mediated disease of the hard tissues of teeth that is caused by bacterial conversion of fermentable carbohydrates into acids resulting in a acidogenic and cariogenic environment which eventually breaks down the dental hard tissues to form a cavity.

Caries of the permanent teeth was reportedly the most common oral condition as per the Global Burden of Disease Study of 2017. Globally, around 2.4 billion people suffer from caries of the permanent teeth and 486 million children suffer from caries of the primary teeth. The overall prevalence for Dental caries in India is about 54.16%. However there is a remarkable variation in dental caries prevalence rates as per age, diagnostic criteria, dentition, and geographical region.

Involvement of the dentin-pulp complex in the carious process is associated with an inflammatory response. The histopathology and the pathophysiology of the diseased pulp have been extensively studied in the literature clearly illustrating that the parts of the pulpal organ under the inflamed pulpal tissue even in so called "irreversible pulpitis" remain vital or if slightly inflamed are often capable of retaining their vitality especially in the radicular portion. Therefore, there is a growing focus on conserving pulp vitality in different types of teeth with pulp involvement.

Vital pulp therapies are a collection of treatment procedures that aim to conserve the vitality of the pulpal tissue that is affected by the carious process. The procedures include removing the microbial irritation and preventing any new bacterial insult to the pulp by placement of a sealing biocompatible material to protect the pulp from external stimuli. VPT is easier and less invasive than conventional root canal treatment. However the technique is still demanding often requiring magnification and expertise.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
14 Years 至 35 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • The healthy participants (ASA 1 and 2), between ages 14 - 35 years, reporting to AIIMS Nagpur from within a 100 kms radius with carious pulp exposure in mature permanent teeth and with the following clinical and radiographic features will be included in the study:
  • I. Clinical features
  • The clinical diagnosis of reversible pulpitis characterized by mild pain (on Numerical Rating Scale 11) that goes away within a couple of seconds following the removal of the stimulus (113)
  • Positive response to pulp sensibility tests.
  • II. Radiographic features
  • Normal periapical tissues [Periapical index (PAI) score ≤2](114)
  • The presence of carious lesion with radiolucency penetrating three-fourths (deep caries) or the entire (extremely deep caries) dentin thickness

排除标准

  • The patients with the following clinical and radiographic features will be excluded from the study:
  • I. Clinical features
  • A history of spontaneous unprovoked toothache, pain on percussion, a sinus tract, compromised periodontal status (periodontal pockets > 4mm), excessive mobility, crack
  • Profuse hemorrhage from exposure site (>5 minutes)
  • The presence of serous or purulent exudates from the exposure site.
  • Teeth that have experienced traumatic occlusion, non-carious lesions, developmental defects etc.
  • II. Radiographic features
  • The evidence of internal or external resorption, or the calcification of the pulp chamber or canals or presence of condensing osteitis.
  • The presence of radiolucency in the furcation or periapical regions.

研究组 & 干预措施

Standard of Care arm: (Control group) Mineral Trioxide Aggregate (MTA) for miniature pulpotomy

Experimental

Mineral Trioxide Aggregate (MTA) for miniature pulpotomy (MTA MP). MTA serves as a standard of care intervention

干预措施: Mineral Trioxide Aggregate (MTA) for Miniature Pulpotomy (Procedure)

Calcium Silicate doped treated dentin matrix for miniature pulpotomy (CaSi+hTDM MP).

Experimental

Procedure/Surgery: Calcium Silicate doped treated dentin matrix for miniature pulpotomy (CaSi+hTDM MP).

Description: Calcium Silicate doped treated dentin matrix for miniature pulpotomy (CaSi+hTDM MP).

干预措施: Calcium Silicate doped treated dentin matrix for miniature pulpotomy (CaSi+hTDM MP). (Procedure)

结局指标

主要结局

Pulp vitality

时间窗: From enrollment to the end of treatment at 6 months

Pulp vitality assessed by cold testing

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ganesh Jadhav

Associate Professor

All India Institute of Medical Sciences

研究点 (1)

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