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临床试验/NCT04617600
NCT04617600Unknown不适用

Survival Rate After TheraCal PT Pulpotomy Versus MTA Pulpotomy in Children With Vital Primary Molars: A Randomized Controlled Pilot Trial.

Cairo University0 个研究点目标入组 20 人开始时间: 2022年3月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
20
主要终点
Survival rate (Absence of spontaneous pain)

研究概览

简要总结

The aim of the study is to assess the effect of TheraCal PT pulpotomy versus MTA pulpotomy on the survival rate of cariously exposed vital primary molars.

详细描述

for both interventions ,

  1. Informed consent from participating parents.
  2. Baseline records photographs, percussion test, periapical radiograph and personal data collection.
  3. Allocation (concealed by withdrawing a sealed opaque envelope containing eight times folded paper containing the type of dressing material that will be used then writing patient name and I.D. on it and will be opened after performing the access cavity).
  4. Diagnostic chart with personal, medical and dental history will be filled.
  5. Clinical examination will be performed to assess the clinical inclusion criteria. (Pulpal and periapical diagnosis is established after clinical examination).
  6. Preoperative and Postoperative photographs will be taken.
  7. The radiographic examination will be performed by taking periapical x-ray using (parallel technique) through machine to assess the inclusion criteria. The preoperative radiograph will serve as a reference for the follow-up radiographs. Standardization of the technique to avoid any distortion in the vertical dimension and to provide reproducible images using x-ray holding device.
  8. Preoperative and postoperative radiograph will be taken by parallel technique using extension cone paralleling (XCP) film holder.
  9. Administration of inferior alveolar nerve block (Septodont, Scandonest® 2% L Mepivacaine hydrochloride (HCl). 2% and Levonordefrin 1:20,000 Injection, U.S.P.) at the side of the affected tooth.
  10. Application of rubber dam for isolation, then a standardized pulpotomy procedure will be performed using a large sterile round end bur in a high-speed handpiece with copious irrigation, a sharp spoon excavator will remove pulpal tissues to the orifice level. Hemostasis will be achieved by the application of a wet cotton pellet.

Children will then be allocated into either one of the groups alternatively depending on the pulpotomy medicament used as follows:

  • Group I (Experimental group) TheraCal PT pulpotomy.
  • Group II (Control group) MTA pulpotomy.

Group I (Experimental group) TheraCal PT:

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
4 Years 至 7 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Aged 4 to 7 years , in good general health and mentally free.
  • The parents provided written informed consent.
  • Cariously exposed primary molars with reversible pulpitis.
  • Teeth should be vital.
  • Restorable teeth.
  • Hemostasis achieved after complete pulpotomy

排除标准

  • With systemic disease.
  • Physical or mental disability.
  • Unable to attend follow-up visits.
  • Refusal of participation.
  • Previously accessed teeth.
  • History of spontaneous or prolonged pain.
  • Swelling, tenderness to percussion or palpation, or pathological mobility.
  • Pre-operative radiographic pathology such as resorption(internal or external),per-radicular or furcation radiolucency.
  • Haemorrhage control is unachievable after pulpotomy.

研究组 & 干预措施

Mineral trioxide aggregate (MTA)

Active Comparator

Survival rate of cariously exposed vital primary molars using MTA+ Curamed (UI, Kwiatkowskiego 1, 37-450 Staleya Wola, Polka)

干预措施: MTA (Drug)

TheraCal PT

Experimental

Survival rate of cariously exposed vital primary molars using TheraCal PT (BISCO Dental Products, Schamberg IL, U.S.A.)

干预措施: TheraCal PT (Drug)

结局指标

主要结局

Survival rate (Absence of spontaneous pain)

时间窗: "6 months"

Binary outcome measured with direct questioning to the patient

Survival rate (Absence of swelling)

时间窗: "6 months"

Binary outcome measured visually by intraoral/extraoral examination

次要结局

  • Absence of periapical radiolucency or absence of internal/external root resorption("6 months")
  • Time lapse till final restoration performed.("During procedure".)

研究者

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

Reem Mohamed Gaber

Principal investigator

Cairo University

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