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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Periodontal non surgical treatment | Procedure | 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. |
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| Oral Hygiene Instructions | Behavioral | Patients will be motivated and instructed to improve their daily home dental plaque control through the usage of interdental devices and electric toothbrush. | ||
| Surgical Periodontal Treatment | Procedure | 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. |
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| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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adult patients diagnosed with periodontitis
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Filippo Graziani, Prof. | Contact | +393384014984 | filippo.graziani@unipi.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pisa | Recruiting | Pisa | None Selected | 56126 | Italy |
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| ID | Term |
|---|---|
| D010518 | Periodontitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D014080 | Tooth Exfoliation |
| D016745 | Root Planing |
| ID | Term |
|---|---|
| D009063 | Dental Physiological Phenomena |
| D055688 | Digestive System and Oral Physiological Phenomena |
| D012534 | Dental Scaling |
| D003777 | Dental Prophylaxis |
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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 |
| D010517 | Periodontics |
| D003813 | Dentistry |
| D013357 | Subgingival Curettage |
| D011313 | Preventive Dentistry |