Laser Pulpotomy: a Modern-non Pharmacological Alternate to Ferric Sulphate Pulpotomy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Presence of Pain or tenderness or mobility
研究概览
简要总结
Diode lasers could be a viable alternative to ferric sulphate in pulpotomy.
详细描述
Ferric sulphate (FS) has recently replaced formocresol as it has comparable clinical and radiographic outcomes, and is more biocompatible, making it the current material of choice. 6,7 However, some histological studies report inflammatory response caused by FS in the remaining pulp, similar to FC, which may lead to internal resorption and eventually, premature tooth exfoliation.
In contrast to ferric sulphate, diode lasers due to their better antimicrobial action, cell regenerative properties, localized/controlled, and quick mechanism of action, are now being considered as an effective method of pulpotomy in dentistry.
Even with several studies that have been conducted on the efficacy and success of laser pulpotomy, there is still a need for additional data and evidence that would further advocate its use in pulpotomy. Furthermore, there hasn't been any such study conducted in this region, which also highlights the importance of this study.
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
- 4 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Primary molars( either mandibular or maxillary or both) of children in the age range of 4 to 8 years.
- •Absence of spontaneous pain, associated swelling, tenderness to percussion, pathological mobility, sinus tract
排除标准
- •Periapical Abscess
- •Necrotic pulp
- •Teeth nearing exfoliation
- •Non cooperative patients
- •Patients with poor oral hygiene
- •Parents/patients not willing to be a part of study
- •Any drug allergies
- •Any medical history contraindicating the pulp treatment
研究组 & 干预措施
Group A (Ferric Sulphate)
Group A (Ferric Sulphate)
干预措施: (Ferric Sulphate) (Combination Product)
(Diode Laser)
A diode laser (Fona, Germany) with a surgical fiber optic tip of 0.4-0.5mm diameter was used and pulp was ablated till the level of the canal orifice. Settings of laser were of wavelength between 810-980nm, set at 3W power in continuous wave/pulse mode for not more than 2-3 seconds. The operator, assistant and the patient were wearing protective eye wear during this procedure. Afterwards MTA (Cerkamed, Poland) was placed in 1mm thickness over the amputated pulp.
干预措施: Group B (Diode Laser) (Procedure)
结局指标
主要结局
Presence of Pain or tenderness or mobility
时间窗: 1,3,6,9, and 12 months intervals
Teeth will be scored as clinical success if they had absence of pain, tenderness, pathological mobility, and sinus or abscess formation. Presence of any of these signs and symptoms will be scored as clinical failure.
Presence of resorption or periapical pathology
时间窗: 1,3,6,9 and 12 months interval
Radiographic assessment included evaluation of pathological external or internal root resorption, periapical or inter-radicular radiolucency and widening of the periodontal ligament (PDL). Presence of any of these signs on the periapical radiograph will be recorded as a radiographic failure.
次要结局
未报告次要终点
研究者
RANA AHMAD
Assistant professor (Clinical)
Shaheed Zulfiqar Ali Bhutto Medical University