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临床试验/NCT05981352
NCT05981352尚未招募不适用

Clinical, Radiographic and Microbiological Evaluation of Hyaluronic Acid and Amniotic Membrane Allograft in Comparison to Mineral Trioxide Aggregate in Pulpotomy of Primary Molars (Randomized Clinical Trial and In Vitro Study)

Ain Shams University0 个研究点目标入组 36 人开始时间: 2023年10月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
36
主要终点
Radio graphic pulp testing

研究概览

简要总结

The aim of the current study is to evaluate and compare clinical and radiographic success and antibacterial effect of Hyaluronic Acid and Amniotic membrane pulpotomy in primary molars in comparison with MTA pulpotomy (Randomized Clinical Trial and In Vitro Study).

详细描述

Pulpotomy is one of the most used frequently treatment for pulp involved in primary teeth. Pulpotomy is performed in a primary tooth with extensive caries but without evidence of radicular pathology when caries removal results in a carious or mechanical pulp exposure. It is a conservative therapy performed to remove the inflamed coronal pulp tissues followed by application of an effective and compatible bactericidal medicament.

Many different compounds have been suggested include glutaraldehyde, electrosurgery, calcium hydroxide, ferric sulfate, freeze-dried bone, bone morphogenic proteins (BMP), mineral trioxide aggregate (MTA) and Bio dentine (Tricalcium Silicate Cement) as replacement for Form cresol in pulpotomy procedure however.

Pulpotomy has been broadly classified as devitalization, preservation, and regeneration of the remaining pulp tissue. Other materials that has shown immense potential for regeneration like mineral trioxide aggregate (MTA). It is a biocompatible and bio inductive material that has been investigated for endodontic.

Hyaluronic acid (HA) has recently emerged as a material of choice in preserving the vitality of the pulp. It is a natural mucopolysaccharide, carbohydrate polymer from the group of glycosaminoglycans. HA is synthetized on the cytoplasmic surface of plasma membranes and is common in humans and other vertebrates. It is the major component of the inner-cell cement of the capillary wall, and of the extracellular matrix of the connective tissue. Deposition of HA significantly increases during development, morphogenesis, wound repair and regeneration, malignancy, and inflammation.

Hyaluronic acid (HA) or hyaluronan is a hydrated anionic polysaccharide plentiful in the extracellular matrix with a molecular weight of 4000-20,000,000 Da that is found in a variety of tissues including skin, synovial fluid, cartilage, tendons, eyes and embryonic mesenchyme . It is comprised of repeating disaccharides d-glucuronic acid and N-acetyl-d-glucosamine, which are joined together by alternating β-1,4 and β-1,3 glycoside bonding. During bone repair, it encourages the undifferentiated mesenchymal cells to migrate, adhere, and proliferate into osteoblastic cells. Due to its non-toxicity, biocompatibility, biodegradability and non-immunogenicity, and used in ophthalmology and orthopedics as an anti-inflammatory agent and anti bacterial agent.

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, Care Provider)

入排标准

年龄范围
4 Years 至 8 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patients aged from 4 to 8 years old.
  • Patients who are free from ant medical condition.
  • Patients who have a vital deep carious Mandibular primary molar which is indicated for pulpotomy .
  • No clinical signs or symptoms of irreversible pulpitis as pain on percussion, tooth mobility, presence of sinus or fistula, history of swelling , Spontaneous pain.
  • No radiographic evidence of any periapical pathosis , Internal or external root resorption , Absence of discontinuity of lamina dura .
  • Physiological root resorption not more than 1/3 of crown

排除标准

  • Teeth that are badly broken down, that cannot be restored.
  • Presence of uncontrolled bleeding after pulpotomy
  • Patients/ parent guardians that refuse to sign informed consent.

结局指标

主要结局

Radio graphic pulp testing

时间窗: 0 baseline , changes from baseline pulp condition at 3 month, change from the baseline pulp condition at 6 month, change from baseline pulp condition at 9 month, change from base line pulp condition at 12 month.

pulp testing radio graphic measured by digital radio graph parallel technique

clinical pulp testing

时间窗: 0 baseline , changes from baseline pulp condition at 3 month, change from the baseline pulp condition at 6 month, change from baseline pulp condition at 9 month, change from base line pulp condition at 12 month.

pulp testing clinically measured by zurn and seale criteria ,

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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