Bioperio® protocol for treating periodontitis
Performance of the Treatment of Periodontitis According to the Bioperio® Protocol: a Prospective Cohort Study
This project tests the Bioperio® protocol — professional cleaning, oral hygiene coaching, full-mouth subgingival instrumentation, and in severe pockets an enamel matrix protein application — in adults with untreated periodontitis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 5000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Pisa Academic / other |
| Locations | 1 site (Pisa, None Selected) |
| Trial ID | NCT07507474 on ClinicalTrials.gov |
What this trial studies
This was a prospective, single-arm, multicenter observational evaluation of a standardized, patient-centered periodontal care pathway called the Bioperio® protocol. The protocol combined supra-gingival scaling, oral hygiene instruction and motivation, full-mouth subgingival instrumentation, and in Stage III/IV cases adjunctive enamel matrix derivative application for deep pockets. Patients were adults with confirmed periodontitis who had not previously received periodontal treatment and who agreed to follow a defined follow-up schedule. Clinical periodontal outcomes such as pocket depth, attachment level changes, and need for further surgical treatment were used to gauge performance of the protocol.
Who should consider this trial
Good fit: Adults with confirmed periodontitis (proximal attachment loss in ≥2 non-adjacent teeth) who have not previously undergone periodontal treatment and who can attend scheduled visits are ideal candidates.
Not a fit: Patients who are pregnant or breastfeeding, have poorly controlled systemic conditions, have already received periodontal treatment, or cannot complete the proposed treatment plan are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the protocol could improve gum health and reduce pocket depths with a standardized non-surgical approach, potentially reducing the need for surgical intervention.
How similar studies have performed: Bundled non-surgical periodontal programs are widely used and enamel matrix derivatives have shown benefit in some regenerative and surgical settings, but using EMD adjunctively after full-mouth non-surgical instrumentation is less extensively studied.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Pisa, None Selected
- University of Pisa — Pisa, None Selected, Italy (Recruiting)
Study contacts
- Study coordinator: Filippo Graziani, Prof.
- Email: filippo.graziani@unipi.it
- Phone: +393384014984
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.