Patient Perspectives Throughout Peri-Implantitis Treatment
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Peri-implantitis. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Испания
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Patient-Centered Outcomes Throughout Peri-Implantitis Therapy: A Multicenter Prospective Observational Study
Обзор
To evaluate longitudinal changes in oral health-related quality of life (OHRQoL) and other patient-reported outcomes (PROMs) throughout the different stages of peri-implantitis therapy, including diagnosis, non-surgical treatment, surgical treatment, and 6-month follow-up. Secondarily, to explore the influence of clinical, implant-related, and surgical factors on patient-reported outcomes and treatment experience.
Подробное описание
Prospective multicenter observational cohort study conducted at three university centers: the University of Barcelona (coordinating center), the International University of Catalonia, and the University of Valencia.
Patients diagnosed with peri-implantitis and requiring surgical treatment will be consecutively recruited and followed through four evaluation time points:
T0: Diagnosis T1: Six weeks after non-surgical therapy T2: Six weeks after surgical treatment T3: Six-month follow-up
Primary objective:
To evaluate longitudinal changes in oral health-related quality of life (OHRQoL) throughout peri-implantitis therapy. OHRQoL will be assessed using a modified version of the OHIP-14 questionnaire specifically adapted for patients with peri-implantitis.
Secondary objectives:
To assess changes in patient-reported experience measures (PREMs), including pain, anxiety, emotional impact, satisfaction, functional limitations, aesthetic perception, and treatment expectations.
To investigate the association between patient-reported outcomes and clinical parameters such as probing depth, bleeding/suppuration on probing, peri-implant bone loss, tissue phenotype, and defect morphology.
To evaluate whether patient-reported outcomes differ according to the type of surgical treatment performed (access, resective, regenerative, or combined surgery).
To explore the influence of patient-, implant-, and prosthetic-related factors on treatment experience and quality of life outcomes.
At each study visit, participants will complete the patient-reported outcome questionnaire and undergo standardized clinical assessments. The study does not modify routine clinical care, and all treatments will be provided according to current clinical guidelines and clinician judgment. This study aims to provide novel evidence regarding the real-world patient experience throughout peri-implantitis therapy and to support a more patient-centered approach to peri-implant disease management.
Первичные конечные точки
- Change in Oral Health-Related Quality of Life (OHRQoL) [Срок оценки: T0 (immediately after diagnosis), T1 (6 weeks after non-surgical treatment), T2 (6 weeks after surgical treatment), and T3 (6 months after surgical treatment)]
Вторичные конечные точки (12)
- Perceived Pain During Each Stage of Treatment (VAS, 0-100 mm) [Срок оценки: T1 (6 weeks after non-surgical treatment), T2 (6 weeks after surgical treatment), and T3 (6 months after surgical treatment).]
- Anxiety and Concern Related to Diagnosis and Treatment (VAS, 0-100 mm) [Срок оценки: T0 (immediately after diagnosis), T1 (6 weeks after non-surgical treatment), T2 (6 weeks after surgical treatment), and T3 (6 months after surgical treatment).]
- Emotional Impact of Peri-Implantitis (VAS, 0-100 mm) [Срок оценки: T0 (immediately after diagnosis), T1 (6 weeks after non-surgical treatment), T2 (6 weeks after surgical treatment), and T3 (6 months after surgical treatment).]
- Satisfaction with Treatment Received (VAS, 0-100 mm) [Срок оценки: T1 (6 weeks after non-surgical treatment), T2 (6 weeks after surgical treatment), and T3 (6 months after surgical treatment).]
- Perceived Oral Function (VAS, 0-100 mm) [Срок оценки: T0 (immediately after diagnosis), T1 (6 weeks after non-surgical treatment), T2 (6 weeks after surgical treatment), and T3 (6 months after surgical treatment).]
- Perceived Treatment Outcomes Compared with Expectations (VAS, 0-100 mm) [Срок оценки: T1 (6 weeks after non-surgical treatment), T2 (6 weeks after surgical treatment), and T3 (6 months after surgical treatment).]
- Perceived Aesthetic Outcome Following Surgical Treatment (VAS, 0-100 mm) [Срок оценки: T2 (6 weeks after surgical treatment) and T3 (6 months after surgical treatment)]
- Probing Depth (PPD, mm) [Срок оценки: T1 (6 weeks after non-surgical treatment), T2 (6 weeks after surgical treatment), and T3 (6 months after surgical treatment).]
- Radiographic Marginal Bone Level (mm) [Срок оценки: T0 (immediately after diagnosis), T1 (6 weeks after non-surgical treatment), T2 (6 weeks after surgical treatment), and T3 (6 months after surgical treatment).]
- Peri-Implant Bone Defect Configuration [Срок оценки: T2 (during surgical treatment).]
- Width of Keratinized Mucosa (KM, mm) [Срок оценки: T0 (immediately after diagnosis), T1 (6 weeks after non-surgical treatment), T2 (6 weeks after surgical treatment), and T3 (6 months after surgical treatment).]
- Thickness of Keratinized Peri-Implant Mucosa [Срок оценки: T0 (immediately after diagnosis), T1 (6 weeks after non-surgical treatment), T2 (6 weeks after surgical treatment), and T3 (6 months after surgical treatment).]
Критерии участия
Критерии включения
- Adults (≥18 years) diagnosed with peri-implantitis according to the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions (Berglundh et al., 2018).
- Implants presenting bleeding on probing (BoP) and/or suppuration on probing (SoP), increased probing depth, and progressive bone loss compared with previous records.
When previous records are unavailable, implants will be included if they present bleeding and/or suppuration on gentle probing, probing depth ≥6 mm, and a bone level ≥3 mm apical to the most coronal portion of the rough implant surface.
\- For patients requiring multiple peri-implantitis surgeries, only the first surgical intervention will be included.
Критерии исключения
- Patients who, following non-surgical peri-implantitis treatment, present ≤1 site with isolated bleeding on probing, no suppuration on probing, probing depths ≤5 mm, and no progressive bone loss compared with pretreatment bone levels.
- Contraindications to surgical peri-implantitis treatment, including plaque index >20% and bleeding on probing >10%.
- Previous radiotherapy to the head and neck region.
- Uncontrolled diabetes mellitus/hyperglycaemia (HbA1c >7%).
- Pregnancy or breastfeeding at the time of enrollment.
- Alcohol or substance abuse.
- Previous surgical treatment of peri-implantitis at the same implant.
- Inability to complete the postoperative pain assessment (VAS) or the oral health-related quality of life (OHRQoL) questionnaires.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Испания · 1 центр
- Octavi Camps — L'Hospitalet de Llobregat
Идентификаторы
NCT: NCT07694323 · 2025-84-1