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临床试验/NCT05928858
NCT05928858尚未招募3 期

Clinical And Radiographic Evaluation Of Premixed Bio-ceramic Mineral Trioxide Aggregate Versus Calcium Hydroxide In Indirect Pulp Capping Of Young Permanent Molars: A Randomized Controlled Trial

Cairo University0 个研究点目标入组 40 人开始时间: 2023年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
尚未招募
入组人数
40
主要终点
Immediate Postoperative pain

研究概览

简要总结

The present study aims to evaluate the clinical and radiographic success of premixed bio-ceramic MTA versus calcium hydroxide in indirect pulp capping of young permanent molars.

详细描述

Researchers are still in search of an ideal material for pulp capping, and they evaluated numerous dental materials. For many decades, calcium hydroxide has been the 'gold standard' material for maintaining pulp vitality. Both clinically and histologically, it has been found to produce satisfactory results in indirect and direct pulp capping because it can stimulate the formation of tertiary dentine by the pulp and it has antimicrobial properties.

Due to the drawbacks of calcium hydroxide, several materials have been developed, such as NeoPUTTY which is premixed bio-ceramic Mineral Trioxide Aggregate (MTA) that triggers hydroxyapatite. Its firm, non-tacky consistency, wash-out resistance, and bioactivity make it a pediatric dentists' preferred material for every pulp need. It also delivers ready-to-use material for immediate placement with zero waste, saving cost and chair time.

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
6 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patients who have young permanent molars with deep carious lesions.
  • Restorable young permanent molars with no clinical symptoms of irreversible pulpitis.
  • Permanent molars with no clinical or radiographic signs of pulp necrosis including swelling, fistula, pain on percussion,pathologic tooth mobility, thickening of the periodontal ligament space, radiolucency at the periapical area.

排除标准

  • Medically compromised patients who have systemic disease.
  • Uncooperative patients who refuse treatment
  • Permanent molars that were previously restored
  • Children whose parents or caregivers refuse to participate in the study.

研究组 & 干预措施

Premixed Bio-ceramic MTA

Experimental

Partial caries removal will be carried out then Premixed Bio-ceramic MTA will be applied as indirect pulp capping agent followed by Glass ionomer filling and composite restoration

干预措施: Premixed Bio-ceramic MTA (Drug)

Calcium hydroxide

Active Comparator

Partial caries removal will be carried out then calcium hydroxide will be applied as indirect pulp capping agent followed by Glass ionomer filling and composite restoration

干预措施: Calcium hydroxide (Drug)

结局指标

主要结局

Immediate Postoperative pain

时间窗: one week

post operative pain by Verbal analogue scale.It is a 10 cm long horizontal line with points labeled from 0 to 10 where (0) indicates no pain, (1-3) mild pain, (4-6) moderate pain, and (7-10) severe pain.

次要结局

  • Soft tissue pathology(3,6,9,12 month)
  • Radiographic changes(3,6,9,12 month)
  • The thickness of newly formed dentin(3,6,9,12 month)

研究者

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

Aya Adel Abd El-Hafez Osman Hamza

Assistant lecturer

Cairo University

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