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临床试验/CTRI/2024/06/069664
CTRI/2024/06/069664招募中2 期

Cone Beam Computed Tomographic evaluation of dentin bridge formation using Mineral Trioxide Aggregate with Melatonin and Freeze Dried Amniotic Membrane for Direct Pulp Capping in permanent Molars A Randomized Controlled Trial

Subbaiah Institute of Dental Sciences NH Purle Shivamogga Karnataka India1 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2024年7月18日最近更新:

试验速览

阶段
2 期
状态
招募中
发起方
入组人数
78
试验地点
1
主要终点
Dentin bridge formation in the compared groups evaluated with the help of intra oral periapical radiograph (IOPAR) and Cone Beam Computed Tomography (CBCT)

研究概览

简要总结

The vitality of the pulp is essential for the protection of the tooth structure and the maintenance of proper physiological function. Following pulp exposure and Direct Pulp Capping, early changes include hemorrhage and moderate inflammation, resolved during the first week [1] In turn, this might also provide a conducive environment for the formation of reparative dentin if the bacterial irritation and inflammatory reaction are successfully mitigated. The release of calcium ions from the DPC biomaterials stimulates the precipitation of calcium carbonate in the wound area and thereby contributes to the initiation of mineralization. After placing Mineral Trioxide Aggregate (MTA) material over the exposed pulp, MTA activates the progenitor cells (fibroblast) migration from the central pulp to the exposure area. This helps to promote their proliferation and differentiation into odontoblast-like cells without inducing apoptosis in the pulp cells [2]. MTA induces a time-dependent environment that is proinflammatory and promotes wound regeneration through upregulation of cytokines [3]. Cytokine upregulation is responsible for the induction of biomineralization by the production of collagen fibrils or apatite-like clusters at the dentin-MTA interface. MTA releases calcium ions which exert antibacterial effects and promote mineralization beneath the pulp exposure area and has the potential to maintain the vitality of the pulp [4]. Previosly melatonin given orally in animal studies have shown to have similar effects such as MTA. Human Amniotic Membrane has also shown healing of inflammed pulp when placed direcly on exposed pulp.[5,6,7]

References:

1) ElSebaai A, Wahba AH, Grawish ME, Elkalla IH. Calcium hydroxide paste, mineral trioxide aggregate, and formocresol as direct pulp capping agents in primary molars: A randomized controlled clinical trial. Pediatr Dent 2022;44(6):411-5.E14-E15.

2) Bui AH, Pham KV. Evaluation of reparative dentine bridge formation after direct pulp capping with biodentine. Int Soc Prevent Communit Dent 2021;11:77-82.

3) Reyes-Carmona JF, Santos AS, Figueiredo CP, Baggio CH, Felippe MC, Felippe WT, et al. Host–mineral trioxide aggregate inflammatory molecular signaling and biomineralization ability. J Endod 2010;36:1347–53.

4) Kunert M, Lukomska-Szymanska M. Bio-inductive materials in direct and indirect pulp capping—a review article. Mater 2020;13:1204.

5) Johri S, Verma P, Bains R,Human amniotic membrane as therapeutic agent in pulpotomy of permanent molars. BMJ Case Rep 2021;14:e243414.

6) Amniotic Membrane versus Formocresol as Pulpotomy Agents in Human  Primary Molars: An in vivo Study Pesquisa Brasileira em Odontopediatria e Clinica Integrada 2017, 17(1):e3794

7) Julia Guerrero-Gironés, Antonia Alcaina-Lorente, Clara Ortiz-Ruiz, Eduardo Ortiz-Ruiz. Melatonin as an Agent for Direct Pulp-Capping Treatment. Int. J. Environ. Res. Public Health 2020, 17, 1043.

8) Keskin Åž, Åžengül F, Åžirin B. Evaluating the cytotoxic effect of melatonin and oxyresveratrol on dental pulp stem cells. Eurasian J Med (2023);55(1):32-36.

9) Rafiqul islam, Md refat readul islam, tora tanaka. Direct pul capping procedures - evidence and practice. Jpn Dent Sci Rev, 2023 Dec, 59:48-61.

10) Cobanoglu N, Alptekin T, Kitagawa H, Blatz MB, Imazato S, Ozer F. Evaluation of human pulp tissue response following direct pulp capping with a self-etching adhesive system containing MDPB. Dent Mater J 2021;40:689–96.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

年龄范围
20.00 Year(s) 至 30.00 Year(s)(—)
性别
All

入选标准

  • Patients with class 1 deep carious lesion in mandibular first and second molar Teeth with vital pulp, mature apex.

排除标准

  • Patients with habit of tobacco chewing and smoking Pregnant and lactating mothers Diabetic patients Teeth with immature apex, periapical pathosis Teeth with irreversible pulpitis.

结局指标

主要结局

Dentin bridge formation in the compared groups evaluated with the help of intra oral periapical radiograph (IOPAR) and Cone Beam Computed Tomography (CBCT)

时间窗: Baseline response before starting the procedure, immediately after treatment, 3 months, 6months, 9months and 12 months after treatment

次要结局

  • Resolution of signs and symptoms clinically and radiographically(Resolution of pain assessed with help of pain scale)

研究者

发起方
Subbaiah Institute of Dental Sciences NH Purle Shivamogga Karnataka India
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

DrPraveena Sharma

Subbaiah Institute of Dental Sciences

研究点 (1)

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