Patient-Centered Outcomes Throughout Peri-Implantitis Therapy: A Multicenter Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Change in Oral Health-Related Quality of Life (OHRQoL)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Change in Oral Health-Related Quality of Life (OHRQoL)
时间窗: T0 (immediately after diagnosis), T1 (6 weeks after non-surgical treatment), T2 (6 weeks after surgical treatment), and T3 (6 months after surgical treatment)
Change in oral health-related quality of life throughout peri-implantitis treatment, assessed using the Spanish version of the Oral Health Impact Profile-14 (OHIP-14sp). The total OHIP-14sp score ranges from 0 to 56, with higher scores indicating worse oral health-related quality of life. The outcome will be expressed as the total OHIP-14sp score and compared across the four study time points. Unit of Measure: OHIP-14sp total score (0-56)
次要结局
- Perceived Pain During Each Stage of Treatment (VAS, 0-100 mm)(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)(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)(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)(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)(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)(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)(T2 (6 weeks after surgical treatment) and T3 (6 months after surgical treatment))
- Probing Depth (PPD, mm)(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)(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(T2 (during surgical treatment).)
- Width of Keratinized Mucosa (KM, mm)(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(T0 (immediately after diagnosis), T1 (6 weeks after non-surgical treatment), T2 (6 weeks after surgical treatment), and T3 (6 months after surgical treatment).)
- Age(T0 (baseline))
- Sex(Time Frame: T0 (baseline))
- Smoking Status(T0 (baseline))
- Cigarettes Smoked per Day(T0 (baseline))
- Relevant Systemic Comorbidities(T0 (baseline))
- Toothbrushing Frequency(T0 (baseline))
- Toothbrush Type(T0 (baseline))
- Interproximal Cleaning Method(T0 (baseline))
- Frequency of Interproximal Cleaning(T0 (baseline))
- Reason for Previous Tooth Loss(T0 (baseline))
- Dental Arch(T0 (baseline))
- Implant Position(T0 (baseline))
- Specific Implant Site(T0 (baseline))
- Implant Brand(T0 (baseline))
- Implant Model(T0 (baseline))
- Implant Surface(T0 (baseline))
- Prosthetic Connection Type(T0 (baseline))
- Restoration Retention Type(T0 (baseline))
- Year of Prosthetic Loading(T0 (baseline))
- Total Number of Implants per Patient(T0 (baseline))
- Year of Implant Placement(T0 (baseline))
- Bleeding and/or Suppuration on Probing (BoP/SoP)(T0 (immediately after diagnosis), T1 (6 weeks after non-surgical treatment), T2 (6 weeks after surgical treatment), and T3 (6 months after surgical treatment).)
- Type of Surgical Procedure(T2 (during surgical treatment))
- Postoperative Wound Dehiscence(T2 (6 weeks after surgical treatment))
- Postoperative Complications(T2 (6 weeks after surgical treatment) and T3 (6 months after surgical treatment))
研究者
Octavi Camps-Font
Associate Professor
University of Barcelona