Performance of the Treatment of Periodontitis According to the Bioperio® Protocol
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Periodontal non surgical treatment, Oral Hygiene Instructions, Surgical Periodontal Treatment.
- Who it may be relevant to
- Registry conditions: Periodontitis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Performance of the Treatment of Periodontitis According to the Bioperio® Protocol: a Prospective Cohort Study
Overview
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.
Interventions
- Procedure Periodontal non surgical treatment
Non surgical periodontal therapy performed with ultrasonics and manual instruments. In patients affected by stages III-IV periodontitis, the adjunctive usage of wound healing enhancers will be applied in sites with PPD \>5 mm. - Behavioral Oral Hygiene Instructions
Patients will be motivated and instructed to improve their daily home dental plaque control through the usage of interdental devices and electric toothbrush. - Procedure Surgical Periodontal Treatment
In some selected patients, whose periodontal defects will not heal despite consecutive non surgical interventions, periodontal surgical treatment, with or without regenerative devices, will be implemented.
Primary outcome measures
- Pocket Closure [Time frame: 3 months and subsequent follow-ups]
- Periodontitis Patient Resolution [Time frame: 3 months and subsequent follow-ups]
Secondary outcome measures (8)
- Change in Probing Pocket Depth (PPD) [Time frame: 3 months and subsequent follow-ups]
- Change in Clinical Attachment Level (CAL) [Time frame: 3 months and subsequent follow-ups]
- Change in Full-Mouth Bleeding Score (FMBS) [Time frame: 3 months and subsequent follow-ups]
- Change in Number of Deep Pockets [Time frame: 3 months and subsequent follow-ups]
- Gingivitis Patient Resolution [Time frame: 3 months and subsequent follow-ups]
- Psychometric testing and Oral Health Related Quality of Life [Time frame: 3 months and subsequent follow-ups]
- Capillary blood sampling via finger prick [Time frame: 3 months and subsequent follow-ups]
- Biologic fluid samples [Time frame: 3 months and subsequent follow-ups]
Eligibility criteria
Inclusion criteria
- 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 criteria
- Pregnancy or breastfeeding
- Patients previously treated for periodontitis
- Poorly controlled systemic conditions
- Refusal to participate
- Patients who did not complete the proposed treatment plan
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- University of Pisa — Pisa
Identifiers
NCT: NCT07507474 · BIOPERIO