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临床试验/CTRI/2025/08/093432
CTRI/2025/08/093432尚未招募不适用

Comparative Evaluation of Mineral Trioxide Aggregate, Biodentine and TheraCal LC In Vital Pulp Therapy In Management Of Permanent Molars With Symptomatic Pulpitis: An In-vivo Study

Dr. Prashant Srivastava1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年9月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
90
试验地点
1
主要终点
Clinically assessment of the efficacy of Vital Pulp therapy using MTA, Biodentine and Theracal LC will be assessed

研究概览

简要总结

·       Pulp vitality is an important aspect in determining a tooth’s long-term
health and survival, as exposed vital pulp has an intrinsic capacity for
healing. By eliminating contaminated tissue and promoting dentin bridge
formation with a minimally invasive approach: Vital Pulp Therapy works to
preserve and protect the pulpal vitality of a tooth that has undergone
mutilating factors such as dental caries, trauma, and operative failure,
especially when pulp inflammation is limited to the outermost layers and the
deeper layers are healthy. Although root canal therapy is well recognized to
produce reliable results, it leaves teeth prone to fracture, and it would be
preferable to provide patients with an alternative minimal invasive approach.
Hence the argument for vital pulp therapy is that radicular pulp tissue is
healthy or capable of recovering after surgical amputation of the damaged or
contaminated coronal pulp.1,2,3

·       Direct pulp capping, which includes applying a protective pulp capping material directly over the exposure location, is typically indicated in a recent exposure of pulp that is pinpoint-sized. Indirect pulp capping is a treatment in which non-mineralizable carious tissue is removed, leaving a thin layer of remaining sound dentin at the deepest site of the cavity to prevent pulp exposure and the caries affected dentin is capped with suitable biocompatible material. In contrast, pulpotomy is described as the partial removal of the pulp (coronal component) while keeping the radicular pulp intact after establishing adequate hemostasis and restoration done with biocompatible materials.4,5

Since diagnosis is a crucial component of treatment planning in endodontics, dental pulp testing is an important and indispensable diagnostic tool. Sensory nerves of different sizes are significantly affected by changes in intra-pulpal pressure; when pressure levels rise, larger diameter A-delta fibers are mostly blocked and smaller diameter C-fibers are activated. C-fibers may continue to function even if the pulp degenerates as a result of the underlying disease because they are more resistant to hypoxia. The most commonly used pulp sensibility tests are thermal and electrical tests that stimulate the pulpal nerves either by conducting an electrical current through the tooth, which causes the odontoblast processes to move and subsequently mechanically stimulate the pulpal nerves, or with dentinal fluid displacement at temperature variations.

·       Despite recent technological advancements in dental materials, like
improved biocompatibility, regenerative dentin capacity, bioactivity, fast
setting time and decreased solubility, there still remains a quest for the
perfect vital pulp therapy agent. Furthermore, research is currently ongoing in order to achieve the
greatest possible clinical and radiographic success in permanent dentitions and
the demand for better medications has opened the door for more clinical
investigations to explore the effectiveness rate of Vital Pulp Therapy (VPT)
in teeth using various protocols.7,8

·       Mineral Trioxide Aggregate (MTA) is a calcium silicate-based cement, developed by Torabinejad  that has been extensively researched and reported to provide high success rates(~90%) of treatment outcomes in vital pulp therapy .It is composed of portland cement (75%), bismuth oxide (20%) and  gypsum (5%). Portland cement is a combination of tricalcium silicate, dicalcium silicate, tricalium aluminate & tetracalciumaluminoferrite. In comparison to calcium oxide, it has many advantages including a homogenous dentinal bridge formation with fewer tunnel defects, sustained calcium release, biocompatibility, sealing ability, long-term stability, low solubility, hygroscopic nature, excellent sealing ability, solubilization of bioactive proteins, and ability for tissue remineralization. Although MTA has a greater success rate, the disadvantages of this material, including its high cost, technique sensitivity, longer setting time, potential for tooth discoloration and inclusion of poisonous heavy metals, have led researchers to hunt for other materials. Yet numerous studies have used MTA as a gold standard medicament in vital pulp therapy.9,10

·       Biodentine, a bioactive dentine substitute, composed of Tricalcium Silicate(80%), with Zirconium oxide as a radio-opacifier, calcium carbonate(15%) as a filler and water as setting accelerator of Calcium Chloride. It has been reported to have superior mechanical properties like better color stability, easier handling and manipulation and fast setting time. Its major drawbacks are low radioopacity and difficulty in maintaining a specific consistency.9,10,11,12

Theracal LC (Bisco,USA) was introduced to address the lack of adhesion between the resins and calcium silicate based materials in final restorations. Theracal LC is a calcium silicate filled, light-cured liner which provides an insulative and protective layer for pulp-dentin complex. Theracal LC releases calcium which enhances development of hydroxyapatite which in turn forms dentine bridge. It has superior bonding capacity compared to composite and glass-ionomer cement with a significant  bioactivity.Additional research is required to estimate its efficacy over a longer period of time. The newly developed materials have the ability to stimulate the pulp progenitor cells in an improved manner and there is ever growing demand for new developments of bioactive materials for Vital pulp Therapy (VPT). However, their long term success in permanent teeth still needs to be supported by further research.

 There
have been studies which have been conducted in- vitro and most of them are in
primary dentition. However, there are quite limited In-Vivo studies
and case reports which have been done on *Permanent
teeth* to substantiate the effects of MTA, Biodentine and Theracal LC and
compare their clinical efficacy and radiographical analysis in contrast with
each other under different vital pulp therapy procedures.The purpose of this study is to
provide comparison between these bioactive materials of choice in Vital Pulp
Therapy in treatment of permanent teeth with symptomatic pulpitis.

研究设计

研究类型
Interventional
分配方式
Other
盲法
None

入排标准

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

入选标准

  • 1.Systemically healthy patients (Category: ASA 1) aged between 18-50 years diagnosed with symptomatic or asymptomatic reversible or irreversible pulpitis on a permanent molar teeth.
  • 2.Caries extending to inner dentin(3rd or quarter) 3.Periodontially healthy patient 4.Tooth without clinical/radiographic sign of apical periodontitis.
  • 5.The teeth that respond positively to electric pulp test as well as to cold tests.

排除标准

  • 1.Teeth with crown/root fractures, acute or chronic apical abscess, compromised periodontium, and open apex will be excluded.
  • 2.Teeth exhibiting signs and symptoms of chronic irritation such as swelling, mobility, sinus tract.
  • 3.Radiographic evidence of pathologic root resorption, inter-radicular bone loss, calcification in canal and periapical cysts.
  • 4.Teeth which will be observed to be non-vital on cavity preparation shall be excluded.

结局指标

主要结局

Clinically assessment of the efficacy of Vital Pulp therapy using MTA, Biodentine and Theracal LC will be assessed

时间窗: 1 month, 3 months and 6 months

次要结局

  • Determination and comparison of the degree of reparative dentine formation after receiving vital pulp therapy with diverse materials.(Determination and comparison of the degree of reparative dentine formation after 1 month, 3 months, 6 months)

研究者

发起方
Dr. Prashant Srivastava
申办方类型
Other [Individual (Self)]
责任方
Principal Investigator
主要研究者

Dr Prashant Srivastava

HKES S.NIjalingappa Institute of Dental Sciences and Research

研究点 (1)

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