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临床试验/NCT01622153
NCT01622153终止不适用

A Prospective Study and Clinical Evaluation of Pre & Post Operative Treatment Comparison of Electrical and Formocresol Pulpotomy Procedures in Primary Molars of Children Undergoing General Anesthesia

University Hospitals Cleveland Medical Center2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2011年6月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
120
试验地点
2
主要终点
Radiographic

研究概览

简要总结

  1. The investigator hypothesize that the Laser pulpotomy will provide adequate and comparable success clinically in primary molars.
  2. The investigators hypothesize that the Laser pulpotomy will provide adequate and comparable success radiographically in primary molars.

详细描述

The health of teeth, their supporting tissues and maintaining their integrity is the primary goal of pulp therapy. Conservative pulp therapy for primary teeth aims to maintain pulp vitality, reduce the need for a pulpectomy, and promote the integrity and retention of such teeth until appropriate exfoliation.(51) A pulpotomy is usually performed for carious exposures of primary teeth with normal pulp or reversible coronal pulpitis, or primary teeth pulpally exposed by trauma (AAPD 2009). A pulpotomy requires healthy radicular pulp capable of healing after amputation of inflamed or infected coronal pulp [Fuks and Eidelman, 1991]. After the coronal pulp is amputated, the remaining vital radicular pulp tissue surface is treated with a long-term clinically successful medicament such as Buckley's Solution of formocresol. (46-52) Electrosurgery has also demonstrated success. (53) The coronal pulp chamber is filled with zinc/oxide, eugenol, or other suitable base, and the tooth is restored with a restoration that seals the tooth from microleakage. The most effective long-term restoration has been shown to be a stainless steel crown.

When the coronal tissue is amputated, the remaining radicular tissue is judged to be vital without suppuration, purulence, necrosis, or excessive hemorrhage that cannot be controlled with a damp cotton pellet after several minutes. In addition to this, if there are no radiographic signs of infection or pathologic resorption then a pulpotomy procedure is indicated. (Camp JH, Fuks AB) Despite concerns of toxicity, mutagenicity and carcinogenicity [Swenberg et al., 1980; Goldmacher and Thilly, 1983; Ranly and Horn, 1987], formocresol (FC) remains a commonly used primary tooth pulpotomy medicament [Hingston et al., 2007]. Various clinical and radiographic success rates (59-100%) have been reported [Mejare, 1979; Naik and Hegde, 2005], attributed to intra-patient variations, clinician and assessor factors, FC concentrations and application times, coronal seal, and study durations.

As technology continues to improve, it allows dentists to treat patients with greater precision, meaning less pain and quicker healing. The diode laser is used in many different dental procedures. It is most commonly used to perform soft-tissue surgery in the mouth. The diode laser's high-energy beam kills bacteria, thus it is often used to sterilize areas of the mouth before or during root canal procedures. (Laser-dentistry/diode-laser) The diode laser represents a whole new way of thinking about dental care. Laser treatment is less painful, more convenient, and more effective than many traditional dental treatments. A study by Bahrololoomi Z, Moeintaghavi A, comparing FC and electrosurgery pulpotomy after nine months of follow up found that clinical and radiographical success rates were 96% and 84% respectively in the electrosurgical group and 100% and 96.8% respectively in the formocresol group. There was no statistical significance and the results showed that the failure rates for electrosurgery pulpotomy were equal to those of formocresol pulpotomy.

Purpose:

Dental care has recently been identified as the most prevalent unmet health need amongst US children (AAPD 2009). This research study investigates another treatment method to help provide dental care to these children by evaluating the success rate of a laser (electrical) pulpotomy compared to formocresol pulpotomy in primary molars with carious pulp exposure. There is a need to study and assess the laser pulpotomy method in order to help create a more efficient and painless treatment.

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
None

入排标准

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

入选标准

  • Restorable carious primary molars with reversible pulpitis and free of clinical or radiographic signs of pulp pathology
  • Males and females
  • Children ages 3-8 years old
  • Children classified under ASA I or II status

排除标准

  • Excluded will be primary molars with clinical or radiographic signs of pathology
  • Children not within age range
  • Absence of parent/caregiver
  • Mentally disabled parent/caregiver
  • Patients not returning for 6 month and 12 month follow up examination appointment

结局指标

主要结局

Radiographic

时间窗: 6, 12, and 18 months

Failure is identified as radiographic: furcation radiolucency, external root resorption

次要结局

  • Clinical(6, 12, 18 months)

研究者

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

Gerald Feretti, DDS, MS, MPH

Chair of Pediatric Dentistry

University Hospitals Cleveland Medical Center

研究点 (2)

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