Instrumentation Time Efficiency and Histologically the Debriding Efficacy of Rotary and Hand Instrumentation Performed on Human Primary Teeth.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 45
- 试验地点
- 6
- 主要终点
- Clinical Success
研究概览
简要总结
The goal of pulp therapy in the primary dentition is to retain the primary tooth as a fully functional part of the dentition, allowing at the same time for mastication, phonation, swallowing, and the preservation of the space required for the eruption of the permanent tooth. The premature loss of primary teeth may cause changes in the chronology and sequence of eruption of permanent teeth. Maintenance of primary teeth until physiological exfoliation prevents deleterious habits in children.
The primary objectives of cleaning and shaping the root canal system are removing soft and hard tissue containing bacteria, providing a path for irrigants to the apical third, supplying space for medicaments and subsequent obturation, retaining the integrity of radicular structure. The choice between pulpotomy and pulpectomy is generally based on the severity of the symptoms clinically and/or radiographically. When indicated, the primary tooth pulpotomy is a relatively simple procedure with generally good clinical results.
详细描述
Patient selection was based on the following criteria:
- the aims and requirements of the study were freely accepted by the parents;
- primary molars with at least 11.0 ± 1.0 mm of working length
- Treatment was limited to patients in good health;
- All teeth had vital and non-vital pulps without a sinus tract;
- Excess of bleeding during a pulpotomy; 6) Presence of enough coronal tooth and root structure;
- No prior pulpectomy treatment on the involved tooth,
- absence of perforation in the internal and/or external furcation area and
- No analgesics or antibiotics were used before the clinical procedures began. Exclusion criteria were patients without inclusion requirements or failure to obtain parent´s authorization, and were excluded if they were older than 7 years old, had a positive history of antibiotic use within the past month, diabetic, hemophilic or if the tooth had root resorption or been previously accessed and initiated a pulpectomy.
Once eligibility was confirmed, the parents were informed of the study design, the clinical procedure involved, and the associated risks. Patients aged 4-7 years of age were enrolled in this study, forty-five teeth (19 maxillaries and 26 mandibular teeth), which had a total of 102 canals and completely formed apices and of minimum 10 mm root length were selected. All selected teeth had mature apexes with no radiographic sign of root resorption.
Of the 45 treated primary molars, 31 teeth were diagnosed as having chronic pulpitis, and 14 as having pulp necrosis that responded negative to hot and cold tests; and, clinically, all pulps were confirmed to be necrotic on entrance into the pulp chamber. Informed consent was obtained and written by the parents from each patient in accordance with the approval of the study by the ethical board of the Universidad Autónoma de Baja California, Facultad de Odontología Tijuana, México. All clinical procedures and measurements were conducted by the author.
A #0 periapical radiograph was taken for each tooth in buccolingual projection to allow proper selection. The selected teeth included 7 second maxillary molars (three canals each), 9 first maxillary molars (2 canals each), 3 central incisors (one canal each), 18 first mandibular molars (2 canals each), 8 second mandibular molars (three canals each) for a total of 45 teeth with 102 canals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Certified endodontists trained in the procedures, devices, and systems investigated took part in the research. All experts tracked a pre-established procedure for Rotary instrument systems and Endo vac system.
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
- •the aims and requirements of the study were freely accepted by the parents
- •primary molars with at least 11.0 ± 1.0 mm of working length
- •Treatment was limited to patients in good health;
- •All teeth had vital and non-vital pulps without a sinus tract;
- •Excess of bleeding during a pulpotomy;
- •Presence of enough coronal tooth and root structure;
- •No prior pulpectomy treatment on the involved tooth,
- •absence of perforation in the internal and/or external furcation area and
- •No analgesics or antibiotics were used before the clinical procedures began.
排除标准
- •patients without inclusion requirements or failure to obtain parent´s authorization, .) patients older than 7 years old,
- •had a positive history of antibiotic use within the past month,
- •diabetic, hemophilic
- •if the tooth had root resorption or been previously accessed and initiated a pulpectomy.
研究组 & 干预措施
Control group
Control Group (n= 15): the root canals were prepared manually with K-files (Dentsply-Maillefer, Ballaigues, Switzerland) and "step back technique" up to size #35.
干预措施: Clean and shape Control group (Procedure)
Control group
Control Group (n= 15): the root canals were prepared manually with K-files (Dentsply-Maillefer, Ballaigues, Switzerland) and "step back technique" up to size #35.
干预措施: Cleand and shape Group 1 (Procedure)
Control group
Control Group (n= 15): the root canals were prepared manually with K-files (Dentsply-Maillefer, Ballaigues, Switzerland) and "step back technique" up to size #35.
干预措施: Clean and shape Group 2 (Procedure)
Group 1
Group 1 (n= 15): the root canals were instrumented with rotary LightSpeed LSX instruments (Discus Dental, Culver City, CA, USA). They were used to complete the canal preparation to a size #50 for the anteriors and molar teeth to size #40.
干预措施: Clean and shape Control group (Procedure)
Group 1
Group 1 (n= 15): the root canals were instrumented with rotary LightSpeed LSX instruments (Discus Dental, Culver City, CA, USA). They were used to complete the canal preparation to a size #50 for the anteriors and molar teeth to size #40.
干预措施: Cleand and shape Group 1 (Procedure)
Group 1
Group 1 (n= 15): the root canals were instrumented with rotary LightSpeed LSX instruments (Discus Dental, Culver City, CA, USA). They were used to complete the canal preparation to a size #50 for the anteriors and molar teeth to size #40.
干预措施: Clean and shape Group 2 (Procedure)
Group 2
Group 2 (n= 15): root canals were instrumented with ProTaper Next (Dentsply Maillefer, Ballaigues, Switzerland) using X1, X2 to X3. 0.5% NaOCl was used for irrigation.
干预措施: Clean and shape Control group (Procedure)
Group 2
Group 2 (n= 15): root canals were instrumented with ProTaper Next (Dentsply Maillefer, Ballaigues, Switzerland) using X1, X2 to X3. 0.5% NaOCl was used for irrigation.
干预措施: Cleand and shape Group 1 (Procedure)
Group 2
Group 2 (n= 15): root canals were instrumented with ProTaper Next (Dentsply Maillefer, Ballaigues, Switzerland) using X1, X2 to X3. 0.5% NaOCl was used for irrigation.
干预措施: Clean and shape Group 2 (Procedure)
结局指标
主要结局
Clinical Success
时间窗: clean and shape with a scale and an average of 3 weeks
Defined as teeth that exhibited no symptoms of pain, tenderness to percussion, swelling, sinus tract, or pathological mobility
次要结局
- Radiological success(obtain the evaluation in about 5 days)
研究者
Jorge Paredes Vieyra
Chairman of Post graduate Programs in Dentistry
Universidad Autonoma de Baja California
