Clinical and Radiographic Evaluation of Vital Pulpotomy Techniques in Primary Molars Using of Premixed Bioactive Bioceramic MTA (Neo-putty) as a Novel Pulpotomy Medication Versus Formocresol: A Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Clinical success
研究概览
简要总结
Despite the benefit of formocresol, there are toxic effects allergic reactions and local soft and hard tissue necrosis have been reported when such formaldehyde compounds were used clinically, however, the adverse effect of the clinically used of this compound are not widely reported. It has been stated that it has a side effect on the permanent successor although it results as a successful technique for the treatment of the primary teeth
详细描述
The rationale for conducting the research:
Nowadays, the introduction of new Bio-inductive materials resulted in the shift of the concept of preservation of radicular pulp tissue to regeneration. Restoration of the anatomical continuity of damaged tissue and disturbed functional status of the radicular pulp tissue require an appropriate method of wound healing which includes well-organized, biochemical and cellular events, leading to the growth and regeneration of injured radicular tissue in a special manner.
A higher standard in bioactive bioceramic putty as manufacture claimed the Neo-Putty® NuSmile is a bioactive bioceramic premixed root and pulp treatment with superior handling properties, promoting hydroxyapatite formation to support the healing process. Neo-Putty® is a premixed bioactive bioceramic root & pulp treatment consisting of an extremely fine, inorganic powder of tricalcium/dicalcium silicate in a water free organic liquid. The product is packaged ready to use. No mixing is required. Neo-Putty® is designed to set in vivo in the presence of moisture from the surrounding tissues. Considering the limitations of these data, we are conduction this clinical trial. The outcomes of this study will have a substantial impact on clinical practice for pediatric patients, as well as patient care, around the world.
Aim of the study:
This randomized clinical trial study will assess clinically and radiographically, the effect of Neo-Putty® as a pulp medicament following coronal pulp amputation in children's primary molars with carious pulp exposure in comparison to Formocresol (FC).
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
- Single (Participant)
入排标准
- 年龄范围
- 4 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •4 -9 years old
- •Primary molars with no spontaneous or provoked pain
- •Primary molars with at least two-thirds of the root length were still present.
- •Primary molars with no sign of internal or other kinds of root or bone resorption.
排除标准
- •Patients with systemic diseases (congenital or rheumatic heart disease, hepatitis, nephritis, tumor, cyclic neutropenia, leukemia, and children on long-term corticosteroid therapy).
- •Un-cooperative patients.
- •Un-restorable primary molars (Grossly broken-down primary molars that have decay extending way under the gingiva and tooth with root caries).
研究组 & 干预措施
full-strength FC
Formocresol pulpotomy is one of the most common procedure in cases of mechanical and carious exposure in primary teeth.
干预措施: A cotton pellet moistened with full-strength FC (Drug)
Neo-Putty®
Neo-Putty® as dressing agents in pulpotomized primary molars. NeoPUTTY® is composed of extremely fine inorganic tricalcium/dicalcium silicate powders in a water-free organic liquid and contains tantalum oxide as the radiopacifying agent.
干预措施: Neo-Putty (Drug)
结局指标
主要结局
Clinical success
时间窗: (at 3,6,9and 12 months)
• Success clinically and radiographically will assess by the number of participants with symptoms-free and no peri-radicular pathology
次要结局
未报告次要终点
研究者
Marwa Ahmed Salmoon
Principal Investigator
October University for Modern Sciences and Arts