Performance of the Treatment of Periodontitis According to the Bioperio® Protocol (BIOPERIO)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Periodontitis
• Intervention / Treatment: Procedure: Periodontal non surgical treatment; Behavioral: Oral Hygiene Instructions; Procedure: Surgical Periodontal Treatment

• Study Type: Observational
• Enrollment (Estimated): 5000

Contacts and Locations

• Study Contact: Name: Filippo Graziani, Prof.; Phone Number: +393384014984; Email: filippo.graziani@unipi.it

Study Locations

• Italy
  • None Selected
    • Pisa, None Selected, Italy, 56126
      • Recruiting
      • University of Pisa
      • Contact: Filippo Graziani; Email: filippograziani@med.unipi.it
      • Contact: Email: rossana.izzetti@unipi.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

adult patients diagnosed with periodontitis

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pocket Closure	Percentage of affected sites (probing pocket depth ≥4 mm at baseline) that achieve a probing pocket depth <4 mm	3 months and subsequent follow-ups
Periodontitis Patient Resolution	Number and percentage of participants showing no sites with PPD>5 mm at 3 months and subsequent re-evaluation	3 months and subsequent follow-ups

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Probing Pocket Depth (PPD)	Change in mean PPD from baseline to 3 months and subsequent re-evaluation. A decrease indicates periodontal condition improvement.	3 months and subsequent follow-ups
Change in Clinical Attachment Level (CAL)	Change in mean CAL from baseline to 3 months and subsequent re-evaluation. A decrease indicates periodontal condition improvement.	3 months and subsequent follow-ups
Change in Full-Mouth Bleeding Score (FMBS)	Change in FMBS from baseline to 3 months and subsequent re-evaluation. 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.	3 months and subsequent follow-ups
Change in Number of Deep Pockets	Change in the number of sites with PPD ≥5 mm and ≥6 mm from baseline to 3 months and subsequent re-evaluation. A decrease indicates periodontal condition improvement.	3 months and subsequent follow-ups
Gingivitis Patient Resolution	Description: 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.	3 months and subsequent follow-ups
Psychometric testing and Oral Health Related Quality of Life	Psychometric outcomes will be evaluated to assess the impact of the intervention on participants' perceived oral health and related quality of life. The Oral Health Impact Profile-14 (OHIP-14) will be administered as a secondary outcome measure at predefined study time points. This validated instrument captures functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability, and handicap associated with oral conditions. Changes in OHIP-14 scores over time will be analyzed to determine the extent to which the intervention influences oral health-related quality of life.	3 months and subsequent follow-ups
Capillary blood sampling via finger prick	Capillary blood samples will be obtained via finger prick to measure C-reactive protein (CRP) and vitamin D levels. The procedure is minimally invasive and will be performed using a sterile, single-use lancet to obtain a small volume of blood. Samples will be analyzed using validated methods to assess inflammatory status (CRP) and vitamin D concentration.	3 months and subsequent follow-ups
Biologic fluid samples	Biologic fluid samples, including saliva and peripheral blood, will be collected from study participants to support exploratory and confirmatory analyses.	3 months and subsequent follow-ups

Collaborators and Investigators

• Sponsor: University of Pisa

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2023
• Primary Completion (Actual): July 5, 2025
• Study Completion (Estimated): December 5, 2030

Study Registration Dates

• First Submitted: March 27, 2026
• First Submitted That Met QC Criteria: March 27, 2026
• First Posted (Actual): April 2, 2026

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: periodontitis; oral hygiene; root planing; non-surgical periodontal therapy; dental scaling; Enamel matrix proteins
• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontitis; Digestive System and Oral Physiological Phenomena; Dentistry; Dental Physiological Phenomena; Dental Scaling; Dental Prophylaxis; Periodontics; Subgingival Curettage; Preventive Dentistry; Root Planing; Tooth Exfoliation
• Other Study ID Numbers: BIOPERIO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No