Timing of Success Evaluation Following Flapless Treatment of Peri-Implantitis: A Prospective Case Series
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Clinical Success Following Flapless Treatment of Peri-Implantitis
研究概览
简要总结
Peri-implantitis is an inflammatory disease around dental implants that causes progressive loss of the bone supporting the implant. Current clinical guidelines recommend treating it first with a non-surgical approach and then checking treatment success, usually between 6 and 12 weeks later. However, it is not known whether this is the best time to check the results, since no previous studies have compared different follow-up time points.
This study will follow patients with peri-implantitis who receive the same non-surgical, flapless treatment. Their implants will be checked at five different times after treatment (6 and 12 weeks, and 6, 9, and 12 months) to see how the clinical outcome changes over time. The main goal is to find out how treatment success evolves at these different time points, and whether the results seen early (at 6 weeks) match the final results seen at 12 months
研究设计
- 研究类型
- 观察性
- 观察模型
- 队列研究
- 时间视角
- 前瞻性
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
- Patients aged 18 years or older.
- General health status compatible with dental treatment (ASA I-II).
- Ability to understand the study, sign the informed consent form, and comply with the follow-up protocol.
- Presence of one or more dental implants in function for at least 12 months, placed at any center, regardless of connection type or the presence of platform switching.
- Screw-retained implant-supported prostheses (single-unit, partial, or complete).
- Presence of at least one implant diagnosed with peri-implantitis, according to the criteria of the 2017 Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions.
排除标准
- Refusal to participate in the study or inability to provide informed consent.
- Non-acceptance of the proposed treatment.
- Pregnancy or breastfeeding.
- Treatment with drugs or presence of diseases that may alter the healing of peri-implant tissues or interfere with the response to treatment (e.g., immunosuppressants, systemic corticosteroids at immunosuppressive doses, or treatment with antiresorptive or antiangiogenic agents).
- Implants restored with cemented prostheses.
- Implants with mobility or with radiographic bone loss exceeding 50%.
- Surgical or non-surgical peri-implant treatment of the affected implant within the previous 12 months.
- Systemic antibiotic treatment within the previous 3 months.
研究组 & 干预措施
Flapless treatment
干预措施: Flapless non-surgical treatment of peri-implantitis (Procedure)
结局指标
主要结局
Clinical Success Following Flapless Treatment of Peri-Implantitis
时间窗: 6 weeks, 12 weeks, 6 months, 9 months, and 12 months after treatment
Clinical success, recorded dichotomously (success/no success), assessed at six sites per implant. An implant is classified as a clinical success when probing depth (PD) is ≤5 mm at all six sites, bleeding on probing is present at, at most, one site and presents as an isolated spot rather than a line or profuse bleeding, and suppuration is absent at all sites.
次要结局
- Arch (Maxilla/Mandible)(Baseline (T0))
- Location (Anterior/Premolar/Molar)(Baseline (T0))
- Implant Type (Bone Level/Tissue Level)(Baseline (T0))
- Age (Years)(Baseline (T0))
- Sex (Male/Female)(Baseline (T0))
- Smoking Status (Never Smoker/Former Smoker/Current Smoker)(Baseline (T0))
- Periodontal Diagnosis (Stage I-IV; Grade A-C)(Baseline (T0))
- Implant Length and Diameter (mm)(Baseline (T0))
- Surface Type (Machined/Rough)(Baseline (T0))
- Implant-Abutment Connection Type (Internal/External)(Baseline (T0))
- Time in Function (Years)(Baseline (T0))
- Prosthesis Type (Single-Unit/Partial/Multiple)(Baseline (T0))
- Intermediate Abutment (Yes/No)(Baseline (T0))
- Prosthetic Modification During Treatment (Yes/No)(Flapless treatment visit (T-treatment))
- Modified Plaque Index (0-3)(Baseline (T0), and at 6 and 12 weeks, and 6, 9, and 12 months (T1-T5))
- Probing Depth (mm)(Baseline (T0), and at 6 and 12 weeks, and 6, 9, and 12 months (T1-T5))
- Bleeding on Probing (Present/Absent)(Baseline (T0), and at 6 and 12 weeks, and 6, 9, and 12 months (T1-T5))
- Suppuration on Probing (Present/Absent)(Baseline (T0), and at 6 and 12 weeks, and 6, 9, and 12 months (T1-T5))
- Implant-Mucosa Distance (mm)(Flapless treatment visit (T-treatment))
- Keratinized Mucosa (mm)(Flapless treatment visit (T-treatment))
- Retreatment Performed (Yes/No)(12 weeks, and 6, 9, and 12 months (T2-T5))
- Need for Surgical Peri-Implant Treatment (Yes/No)(12 weeks, and 6, 9, and 12 months (T2-T5))
- Implant Loss (Yes/No)(12 weeks, and 6, 9, and 12 months (T2-T5))
- Radiographic Defect Morphology (Supracrestal/Intrabony/Combined)(Baseline (T0))
- Radiographic Bone Level (mm)(Baseline (T0), and at 6 and 12 months (T3, T5), or at any other visit if clinically necessary)
- Intrabony Defect Depth (mm)(Baseline (T0))
- Intrabony Defect Width (mm)(Baseline (T0))
- Intrabony Defect Angle (º)(Baseline (T0))
- Treatment Trajectory (Success Without Retreatment/Success After Retreatment/Persistent Failure at 12 Months/Surgical Treatment or Implant Loss)(12 months (T5))
研究者
研究点 (1)
标识符
- NCT 编号
- NCT07844642
- 其他研究编号
- 39/2026
日期
- 首次提交
- (8天前)
- 首次发布
- (前天)
- 主要完成日期
- (明年)
- 研究完成日期
- (明年)
- 最近核实
- (29天前)
- 最近更新
- (前天)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- UNDECIDED
- 是否有结果
- 否