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临床试验/NCT06200818
NCT06200818已完成不适用

Clinical, Radiographic and Patient's Acceptance

Ain Shams University0 个研究点目标入组 36 人开始时间: 2015年12月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
36
主要终点
Clinical and radiographic success

研究概览

简要总结

The goal of this clinical trial was to compare the clinical and radiographic success of laser versus formocresol pulpotomy in primary molars. The main questions it aimed to answer was:

• Does laser pulpotomy has higher clinical and radiographic success rate as formocresol pulpotomy in primary molars?

Participants were selected according to eligibility criteria to undergo pulpotomy for their lower primary molars under local anesthesia using one of the following techniques:

  • Group 1: Formocresol
  • Group 2: Diode laser Group 3: Er:CrYSGG laser Clinical and radiographic follow up were performed for 18 months

详细描述

In all teeth, local anaesthesia was administered using 7.0 mg/kg 4% articane + 1: 100,000 epinephrine (with a maximum total dosage of 500 mg)

- Rubber dam isolation was done.

Access cavity preparation:

  • In all groups, caries removal was done with a sterile #330 high-speed bur, and coronal access cavity preparation was done with a sterile #4 high-speed round bur using high speed hand piece and water coolant. The access cavity was then refined using a sterile high-speed fissure bur. LASER operating parameters: Figure (10)

  • Wavelength: 2780 nm

  • Repetition rate: 15 Hz

  • Water spray: 80

  • Air : 60

  • Emission mode: Free-running pulsed

  • Tip: MZ 10- 6 mm, Zip Tip

  • Average power: 8 Watt The coronal pulp was amputated by a sterile sharp excavator, the amputated sites were rinsed with water. Hemorrhage was controlled by placing sterile, saline- wetted cotton pellets on the radicular pulp stumps under slight pressure (Thompson et al., 2001) for 5 min for primary hemostasis ( J Dent Res 84(12) 2005). At this stage, the achievement of complete hemostasis was an inclusion criterion. If bleeding recommenced afterwards, partial pulpectomy was performed and the tooth was excluded from the study.

  • After achieving complete haemostasis pulp stumps were treated according to each group: Group1: (control group)

  • A cotton pellet that was moistened with 1:5 diluted bottle of FC (Formacresol, PREVEST DenPro, Digiana, Jammu, India) was placed over the pulp stumps for 5 minutes. After removal of the cotton, the fixed pulp stumps were capped with reinforced zinc oxide and eugenol base (Zinconol, PREVEST DenPro, Digiana, Jammu, India). Group2: (Diode LASER group)

  • All patients, parents and clinical staff were requested to wear appropriate eye protection goggles during laser application, Figure (12). After achieving hemostasis, pulp stumps was treated with Diode LASER (980 nm).If hemostasis was not achieved, the process was repeated one more time until adequate hemostasis was achieved, Figure (15, 16). Diode LASER radiation (wavelength 980 nm) was delivered to the canal orifices with a special handpiece and fiber glass of 200 μm diameter, Figure (13), the parameters were set at: Figure (14) Emission mode: Pulsed contact mode Time: 2 seconds. Power: 2 Watt power with average power of 1 Watt and total energy of one spot, corresponding to two minutes and 31 seconds exposure was 4.0 J/cm 2. Group3: (Erbium:Chromium,YSGG LASER group) Pulp tissues in this group were treated with Erbium:Chromium,YSGG LASER (2780 nμ). (Waterlase Biolase®, Biolase, Inc., San Clemente, California, USA) Once the pulp chamber was opened, the laser tip was placed into the pulp chamber using for approximately 15 seconds. In most instances, this was repeated three times. If hemostasis was not achieved, the process was repeated one more time until adequate hemostasis was achieved. Er: Cr, YSGG LASER radiation (wavelength 2780 nμ) was delivered with a special handpiece, and a tip: MZ 10- 6 mm, Zip Tip, to the canal orifices.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

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

入选标准

  • •1. Clinical criteria One or more primary teeth indicated for pulpotomy due to carious pulp exposure. No spontaneous pain No swelling No tenderness to percussion No pathological mobility No sinus tract opening No initially unsuccessful hemorrhage control.
  • •Radiographic criteria Teeth without inter-radicular radiolucency No loss of lamina dura or widened periodontal ligament space No physiologic root resorption of more than one-third.

排除标准

  • •Clinical mobility Spontaneous pain Swelling Tenderness to percussion Pathological mobility Non restorable teeth. Teeth with necrotic pulp. Pre-operative radiographic pathology such as resorption, periradicular or furcal radiolucency, a widened periodontal ligament space, or physiological root resorption of more than one-third. Parents / Patients not willing to be a part of the study. Any kind of medical history contraindicating the pulp treatment.

研究组 & 干预措施

Formocresol

Active Comparator

干预措施: Formocresol (Procedure)

Diode laser

Experimental

干预措施: Diode laser (Procedure)

Er:CrYSGG

Experimental

干预措施: Er:CrYSGG (Procedure)

结局指标

主要结局

Clinical and radiographic success

时间窗: 18 months

Clinical success criteria: 1. Restoration intact; 2. No pain or tenderness; 3. No mobility; 4. No swelling; 5. No fistula; 6. No gingival inflammation-represented by pain, redness, or bleeding-around the tooth/crown. Radiographic success at follow-up visits should meet the following criteria: 1\. No external root resorption; 2. No internal root resorption; 3. No inter-radicular bone resorption. 4. No Widening of the periodontal ligament space. 5. No periapical bone resorption.

次要结局

未报告次要终点

研究者

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

Dina Hamdy

Lecturer of pediatric dentistry and dental public health

Ain Shams University

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