RecruitingNCT07507474

Performance of the Treatment of Periodontitis According to the Bioperio® Protocol: a Prospective Cohort Study

Sponsor

University of Pisa

Enrollment

600 participants

Start Date

Dec 5, 2023

Study Type

OBSERVATIONAL

Conditions

Periodontitis

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria4

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

Exclusion Criteria5

Pregnancy or breastfeeding
Patients previously treated for periodontitis
Poorly controlled systemic conditions
Refusal to participate
Patients who did not complete the proposed treatment plan

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Interventions

DIAGNOSTIC_TESTperiodontal probing and charting

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