Randomized Clinical Trial on the Effect of Micro-osteoperforations (MOPs) During Intrusion of Flared Upper Anterior Teeth in Stage IV Periodontitis Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- CAL
研究概览
简要总结
Micro-osteoperforations (MOPs) cause cortical bone injuries and consequently increase the expression of inflammatory mediators, allowing for increased bone and periodontal ligament remodeling associated with orthodontic movement. It remains unclear the effect of orthodontic intrusion combined with MOPs application on teeth with reduced periodontium. The general objective will be to determine the efficacy of MOPs during orthodontic tooth movement (OTM) in terms of periodontal and orthodontic outcomes in stage IV periodontitis patients, case type 2 with pathological tooth migration (PTM), characterized the presence of at least one flared tooth of the upper-anterior sextant with an intrabony defect (intrabony component <5mm)
详细描述
This is a comparative 2-arm parallel single-blinded randomized controlled clinical trial, with allocation ratio of 1:1, aimed to test an intervention (the use of MOPs) on CAL changes 12 months after placing orthodontic appliances. The control intervention will be the same treatment without the bone traumatic intervention.
Sample: Patients with stage IV periodontitis case type 2 characterized with PTM characterized the presence of at least one flared tooth of the upper-anterior sextant with an intrabony defect (intrabony component <5mm) attending the Post-graduate Program of Periodontology and the Post-graduate Program of Orthodontics of the Faculty of Dentistry at the Complutense University of Madrid (UCM).
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients will be included if agreeing to undertake combined periodontal and orthodontic therapy following the clinical practice guideline of stage IV periodontitis patients, and fulfilling the following criteria:
- •adult patients older than 18-year-old;
- •systemically healthy (see exclusion criteria);
- •diagnosed as stage IV (Papapanou et al., 2018) case-type 2 (Herrera et al. 2022) periodontitis;
- •the presence of at least one flared tooth of the upper-anterior sextant with an intrabony defect (intrabonny component <5mm) (experimental teeth);
- •in need of orthodontic therapy.
排除标准
- •systemic diseases (diabetes mellitus, obesity, cardiovascular diseases);
- •any medication that could affect the level of inflammation, (such as chronic antibiotics, phenytoin, cyclosporin, anti-inflammatory drugs, systemic corticosteroids, or calcium channel blockers);
- •pregnant or lactating woman;
- •inability to respond questions or to attend follow-up visits;
- •extreme skeletal malocclusions requiring orthognathic surgery;
- •patients smoking more than 10 cigarettes/day; and
- •the presence of PD greater or equal to 5mm with BOP after step 3 of periodontal therapy
结局指标
主要结局
CAL
时间窗: 12 months
clinical attachment level (CAL) in mm
次要结局
- Radiographic periodontal outcomes(12 months)
- Type of movement(12 months)
- Duration of orthodontic treatment(>12 months)
- Gingival margin level (GM)(12 months)
- Oral health related quality of life questionnaire (OHRQoL)(12 months)
- Aesthetic component of the Index of Orthodontic Treatment Need (IOTN)(12 months)
- Gingival recessions(12 months)
- Pain questionnaire(12 months)
- External apical root resorption (EARR)(12 months)
- Bleeding on probing (BOP)(12 months)
- Plaque index (PI)(12 months)
- Probing pocket depth (PPD)(12 months)
- Suppuration on probing (SOP)(12 months)
- Inflammatory biomarkers in gingival crevicular fluid (GCF)(12 months)
研究者
Concepción Martín Alvaro
Professor in Orthodontics
Universidad Complutense de Madrid