Evaluation of Selective and Stepwise Excavation in Young Permanent Teeth With Deep Caries Lesions (SELECT): A Randomized Controlled Trial in a Practice-Based Research Network
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 666
- 试验地点
- 2
- 主要终点
- Sustained tooth vitality
研究概览
简要总结
The purpose of this clinical trial is to evaluate and compare the outcomes of selective carious tissue removal versus stepwise carious tissue removal in young permanent teeth with deep carious lesions. The primary follow-up will be conducted 1 year after treatment to assess success. A secondary follow-up will take place 3 years post-treatment, utilizing data from dental registries and dental records. The study is a randomized controlled trial conducted within a practice-based research network.
详细描述
The SELECT compares selective carious tissue removal and stepwise excavation in young permanent teeth with deep carious lesions. Unlike the traditional approach of total caries excavation-still widely practiced by dentists-the study implements minimally invasive methods in clinical settings. Conducted within a practice-based research network (PBRN), the study ensures that its findings are highly relevant to real-world clinical environments. Targeting young permanent teeth, a population critical for long-term dental health, the study has a robust randomized controlled trial (RCT) design. Its long follow-up period includes a clinical assessments at 1 year, and at 3 years using dental registry data/dental records. The focus on minimally invasive techniques aligns with contemporary trends in conservative dentistry, and the findings have the potential to inform future guidelines, advancing evidence-based and sustainable treatment practices.
Aim: The aim of the SELECT study is to compare the clinical and long-term outcomes of selective carious tissue removal versus stepwise excavation in managing deep carious lesions in young permanent teeth. The study aims to determine which method is more effective in preserving tooth vitality, reducing complications, and supporting sustainable dental health. The implementation of minimally invasive methods in routine dental practice is a key component of this study, emphasizing the importance of patient-centered and less invasive care.
Selection of participants: Participants will be recruited through the PBRN and all eligible patients will be considered if they comply with the clearly defined inclusion and exclusion criteria.
Statistical plan and data analysis: The sample size calculations is based on the statistical power to reject the null hypothesis H0" No difference between treatment types" at a 5% risk level of type I error. The sample size for each treatment group is determined to be 333 participants based on the primary outcome, with a primary follow-up period of 1 to 1,5 year including an attrition rate of 20%. The success probability for stepwise excavation is set at 90%, with a risk difference of +6 percentage points for selective excavation. The study is powered with a type-I error of 5% and a type-II error of 20%. For the follow-up data after 2-3 years, a base success probability of 80% for stepwise excavation was assumed and a risk difference of +10% for selective excavation rending for a sample size of 392 patients. The outcome will be a vital tooth without pain as a binary variable indicating a successful or unsuccessful treatment and a logistic regression analysis will be performed.
Randomization: Only one deep caries lesion per participant will be randomized. The trial will use block randomization.
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
盲法说明
The statistician
入排标准
- 年龄范围
- 8 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 8- 19 years (last December the year they turn 19 years) A fully erupted molar or pre-molar teeth with dental caries (class I or class II) extending to more than 2/3 of the dentine thickness (and on the bitewing radiograph showing a radiodense zone separating the pulp from the demineralized dentine).
- •Bitewing radiograph has been taken as part of the ordinary dental examination Available for recall at least for 1 year.
排除标准
- •Extraction is planned of the tooth with deep caries in the future with expected spontaneous gap closure.
- •If the carious tooth shows sign or symptoms of irreversible pulp pathology or loss of vitality including:
- •Presence of a sinus tract (fistula)
- •Tenderness to percussion
- •Buccal tenderness
- •Severe sensitivity
- •Evidence of pathology on a periapical radiograph (if radiograph is clinically justified and performed)
- •No written informed consent.
- •Medical condition requiring special considerations with regard of the dental management
- •Dental treatment cannot be performed adequate due to lack cooperation
研究组 & 干预措施
Selective excavation
One visit procedure
干预措施: Selective excavation (Procedure)
Stepwise excavation-two visit procedure
Two-visit procedure
干预措施: Stepwise excavation (Procedure)
结局指标
主要结局
Sustained tooth vitality
时间窗: 1-1,5 years after baseline
The examining dentist will aggregate a combination of clinical tests and radiographic findings that need to be fulfilled, to assess the outcome: sustained tooth vitality. All assessments will be recorded separately. The following measures will be recorded: positive response to cold test, absence of fistula or abscess, absence of tenderness on percussion, no evidence of pulp necrosis based on a periapical radiograph (if clinically justified and performed), no root filling. Additionally, the examining dentist will document which tests have been performed to justify the assessment.
次要结局
- No pain from tooth(1-1,5 years after baseline)
- Sustained tooth without root canal treatment(Up to 3 years (after baseline))
- Tooth survival(Up to 3 years (after baseline))
- Health economic(Up to 3 years (after baseline))
- Quality of life (Qol)(1 -1,5 years after baseline)
研究者
Maria Anderson
Dr
Karolinska Institutet