Performance of the Treatment of Periodontitis According to the Bioperio® Protocol: a Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 5,000
- 试验地点
- 1
- 主要终点
- Pocket Closure
研究概览
简要总结
This multicenter, prospective, single-arm observational study evaluated the clinical performance of the Bioperio® protocol, a standardized, patient-centered framework for managing periodontitis. The protocol combined professional supra-gingival scaling, oral hygiene instruction and motivation, full-mouth subgingival instrumentation, and-in Stage III/IV cases-adjunctive enamel matrix derivative application in deep pockets.
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
- •Confirmed diagnosis of periodontitis (proximal attachment loss in ≥2 non-adjacent teeth)
- •No previous treatment for periodontitis
- •Systemically healthy or with well-controlled chronic medical conditions
- •Willingness to participate in the study and comply with the follow-up schedule
排除标准
- •Pregnancy or breastfeeding
- •Patients previously treated for periodontitis
- •Poorly controlled systemic conditions
- •Refusal to participate
- •Patients who did not complete the proposed treatment plan
结局指标
主要结局
Pocket Closure
时间窗: 3 months
Percentage of affected sites (probing pocket depth ≥4 mm at baseline) that achieve a probing pocket depth \<4 mm
Patient Resolution
时间窗: 3 months
Number of participants achieving a full-mouth bleeding score (FMBS) \<10%. FMBS is a periodontal index used to assess gingival inflammation by recording the presence or absence of bleeding on probing at multiple sites around all teeth. Common systems include the Ainamo and Bay (1975) method, using a 6-site per tooth recording (mesiobuccal, buccal, distobuccal, distolingual, lingual, mesiolingual). The score is calculated as (number of bleeding sites / total number of sites examined) × 100%. So a percentage. Interpretation: low scores (\<10% usually healthy), 10-30% mild inflammation, \>30% significant inflammation. Clinical significance: high scores indicate poor oral hygiene, active gingivitis, risk for periodontitis progression, need for more frequent recall or scaling/root planing.
Pocket Closure
时间窗: 3 months and subsequent follow-ups
Percentage of affected sites (probing pocket depth ≥4 mm at baseline) that achieve a probing pocket depth \<4 mm
Periodontitis Patient Resolution
时间窗: 3 months and subsequent follow-ups
Number and percentage of participants showing no sites with PPD\>5 mm at 3 months and subsequent re-evaluation
次要结局
- Change in Probing Pocket Depth (PPD)(3 months)
- Change in Clinical Attachment Level (CAL)(3 months)
- Change in Full-Mouth Bleeding Score (FMBS)(3 months)
- Change in Number of Deep Pockets(3 months)
- Change in Probing Pocket Depth (PPD)(3 months and subsequent follow-ups)
- Change in Clinical Attachment Level (CAL)(3 months and subsequent follow-ups)
- Change in Full-Mouth Bleeding Score (FMBS)(3 months and subsequent follow-ups)
- Change in Number of Deep Pockets(3 months and subsequent follow-ups)
- Gingivitis Patient Resolution(3 months and subsequent follow-ups)
- Psychometric testing and Oral Health Related Quality of Life(3 months and subsequent follow-ups)
- Capillary blood sampling via finger prick(3 months and subsequent follow-ups)
- Biologic fluid samples(3 months and subsequent follow-ups)
研究者
Filippo Graziani, DDS MClinDent PhD
Full Professor, DMD, MClinDent, PhD
University of Pisa