This multicenter, prospective, single-arm observational study evaluated the 3-month 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.
Study Type
OBSERVATIONAL
Enrollment
600
All clinical periodontal parameters were assessed at baseline and at the 3-month follow-up by calibrated examiners. Probing Instrument: A manual periodontal probe (UNC 15, Hu-Friedy, Chicago, IL, USA) was used. Examiners were calibrated to apply a consistent probing force of 0.25 N using a force-measuring scale. Measurements: For each tooth, six sites were examined: mesiobuccal, mid-buccal, distobuccal, mesiolingual, mid-lingual, and distolingual. Probing Pocket Depth (PPD): Measured in millimeters from the gingival margin to the base of the pocket; rounded to the nearest millimeter. Gingival Recession (REC): Measured in millimeters from the cementoenamel junction to the gingival margin; recorded as a positive value when the gingival margin was apical to the cementoenamel junction. Clinical Attachment Level (CAL): Calculated as PPD + REC for each site. Bleeding on Probing (BOP): Recorded dichotomously (present/absent) at the same six sites per tooth. The full-mouth bleeding score
University of Pisa
Pisa, None Selected, Italy
RECRUITINGPocket Closure
Percentage of affected sites (probing pocket depth ≥4 mm at baseline) that achieve a probing pocket depth \<4 mm
Time frame: 3 months
Patient Resolution
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.
Time frame: 3 months
Change in Probing Pocket Depth (PPD)
Change in mean PPD from baseline to 3 months. A decrease indicates periodontal condition improvement.
Time frame: 3 months
Change in Clinical Attachment Level (CAL)
Change in mean CAL from baseline to 3 months. A decrease indicates periodontal condition improvement.
Time frame: 3 months
Change in Full-Mouth Bleeding Score (FMBS)
Change in FMBS from baseline to 3 months. 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.
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Time frame: 3 months
Change in Number of Deep Pockets
Change in the number of sites with PPD ≥5 mm and ≥6 mm from baseline to 3 months. A decrease indicates periodontal condition improvement.
Time frame: 3 months