Comparison Of Clinical And Radiological Success Of Pulpotomy Treatments Performed With Proroot MTA, NeoPUTTY MTA, TheraCal PT In Primary Teeth
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Clinical Success Of Pulpotomy Treatments Performed With Proroot MTA, NeoPUTTY MTA, TheraCal PT In Primary Teeth
研究概览
简要总结
The goal of this randomized clinical trial is to compare clinical and radiological success rates of NeoPutty MTA, ProRoot MTA and TheraCal PT pulpotomy in 4-10 years old healthy pediatric patients. The main question it aims to answer is:
Which of these 3 materials are best suited for pulpotomy treatment in the aspect of clinical and radiological success rates.
Participants will undergo a pulpotomy treatment in primary molar teeth with one of these materials used.
详细描述
This study was conducted on primary molar patients who applied to Necmettin Erbakan University Faculty of Dentistry Department of Pedodontics for a routine check-up, did not have any systemic problems, had a score of 3 and 4 according to the Frankl Behavior Scale, and whose parents' approval could be obtained, and had a pulp-related and active caries appearance in the lower jaw. Patients between the ages of 4 and 10 who are indicated for dental pulpotomy treatment will be included.
In our prospective randomized clinical study;
Pulpotomy treatment; Infiltrative/mandibular anesthesia is applied to the primary lower molar teeth, which are in contact with the pulp and have not experienced spontaneous pain, and wait until numbness occurs. Under rubber dam isolation, soft caries in the lower primary molar tooth is removed with a steel round bur.
Removal of pulp tissue: Starting from where the pulp is exposed, 1-2 mm is removed with a water-cooled high-speed diamond round bur.
Bleeding Control: It is washed with sterile serum and the cavity is disinfected using a cotton pellet impregnated with 2.5% Sodium Hypochlorite. It is checked that there is no residual pulp tissue left. For hemostasis, a cotton pellet impregnated with physiological saline is placed in the cavity.
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
- 4 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Primary molars with active caries and pulp exposure, assessed after intraoral periapical radiograph examination
- •Presence of pulp exposure during caries excavation
- •More than two-thirds of root length present
- •No history of spontaneous pain
- •Children aged 4-10 years with Frankl's positive or definitely positive behavior
排除标准
- •Teeth with internal or external root resorption, periapical lesions, or widening of the periodontal ligament (PDL)
- •Presence of sinus tracts or history of swelling
- •Uncontrolled pulpal bleeding from the tooth, even after 5 minutes
- •No pulp exposure during caries excavation
- •Patients or parents unwilling to participate in the study
研究组 & 干预措施
ProRoot MTA White (Tulsa Dental Products, Tulsa, USA)
Pro Root MTA Root Canal Repair Material
干预措施: ProRoot MTA Pulpotomy (Other)
NeoPUTTY (NuSmile, Houston, USA)
Next Generatıon Pre-Mıxed Root & Pulp Treatment Materıal
干预措施: NeoPUTTY MTA Pulpotomy (Other)
ThraCal PT (Bisco Dental Products, Schaumburg IL, Amerika)
BISCO's TheraCal PT is a dual-cured, resin-modified calcium silicate pulpotomy treatment.
干预措施: TheraCal PT Pulpotomy (Other)
结局指标
主要结局
Clinical Success Of Pulpotomy Treatments Performed With Proroot MTA, NeoPUTTY MTA, TheraCal PT In Primary Teeth
时间窗: 6 months and 9 months post-treatment
Clinical success will be evaluated at 6- and 9-month follow-up examinations by assessing the following parameters: spontaneous pain, tenderness to percussion, swelling, sinus/fistula formation, and pathological mobility. Each parameter will be recorded as positive (present) or negative (absent). Tooth mobility will be graded according to Miller's Mobility Classification (Grades 0-3). A tooth will be considered clinically successful if all parameters are negative (no symptoms) and mobility is within Miller's Grade 0-1. Data will be aggregated and reported as the number and percentage of teeth with clinical success for each pulpotomy material group (ProRoot MTA, NeoPUTTY, and TheraCal PT).
Clinical And Radiological Success Of Pulpotomy Treatments Performed With Proroot MTA, NeoPUTTY MTA, TheraCal PT In Primary Teeths
时间窗: 6 months and 9 months post-treatment
Radiographic success will be evaluated at 6- and 9-month follow-up visits using standardized periapical radiographs. Each radiograph will be examined for the presence or absence of the following findings: periapical radiolucency, furcal involvement, internal or external root resorption, and widening of the periodontal ligament space. Each parameter will be recorded as positive (absent pathology) or negative (presence of any pathology). Teeth showing no pathological findings (i.e., all parameters positive) will be classified as radiographically successful, whereas those showing any pathological change (negative) will be classified as radiographic failures. Evaluations will be performed independently by two blinded examiners. Data will be aggregated and reported as the number and percentage of radiographically successful teeth for each pulpotomy material group (ProRoot MTA, NeoPUTTY, and TheraCal PT).
次要结局
未报告次要终点
研究者
Halenur Altan
Professor
Necmettin Erbakan University