Effect of MOPs During Orthodontic Movement in Periodontitis Patients

Официальное название

Randomized Clinical Trial on the Effect of Micro-osteoperforations (MOPs) During Intrusion of Flared Upper Anterior Teeth in Stage IV Periodontitis Patients

Обзор

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)

Подробное описание

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).

Вмешательства

• Процедура Micro-ostoperforations (MOPs)
  3 MOPs will be performed in the bone next to the root of the experimental tooth. MOPs will be performed using the Excellerator® (Propel Orthodontics, Denstply, Sirona)

Первичные конечные точки

• CAL [Срок оценки: 12 months]

Вторичные конечные точки (12)

• Type of movement [Срок оценки: 12 months]
• Duration of orthodontic treatment [Срок оценки: >12 months]
• External apical root resorption (EARR) [Срок оценки: 12 months]
• Probing pocket depth (PPD) [Срок оценки: 12 months]
• Gingival margin level (GM) [Срок оценки: 12 months]
• Gingival recessions [Срок оценки: 12 months]
• Bleeding on probing (BOP) [Срок оценки: 12 months]
• Suppuration on probing (SOP) [Срок оценки: 12 months]
• Plaque index (PI) [Срок оценки: 12 months]
• Radiographic periodontal outcomes [Срок оценки: 12 months]
• Inflammatory biomarkers in gingival crevicular fluid (GCF) [Срок оценки: 12 months]
• Oral health related quality of life questionnaire (OHRQoL) [Срок оценки: 12 months]

Критерии участия

Критерии включения

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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

• Faculty of Odontology, University Complutense Madrid — Madrid

Идентификаторы

NCT: NCT06068270 · URI_113-210923

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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