An observational study in Periodontitis, sponsored by University of Pisa. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-01.
Sponsored by University of Pisa · Observational
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.
1,231 studies on the registry are indexed under Periodontitis; 295 are open to participants now.
This study's planned enrollment of 5,000 is above the median of 90 across 372 observational studies indexed under Periodontitis.
Browse Periodontitis studies →University of Pisa is the lead sponsor of 113 studies on the registry; 28 are open to participants now.
Counted across the registry records on this site, refreshed daily.
adult patients diagnosed with periodontitis
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Also known as: Scaling and root planing
Patients will be motivated and instructed to improve their daily home dental plaque control through the usage of interdental devices and electric toothbrush.
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.
Also known as: periodontal surgery
Pocket Closure
Percentage of affected sites (probing pocket depth ≥4 mm at baseline) that achieve a probing pocket depth \<4 mm
Time frame: 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
Time frame: 3 months and subsequent follow-ups
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 3 months and subsequent follow-ups
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Dec 2023 to primary completion in Jul 2025, 19 months.
Of 85 non-industry observational studies under Periodontitis, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 30. This study's 19 months is above that.
Counting every sponsor, half of 86 studies reached it within 13 months; a quarter within 7 and three quarters within 30.
How these figures are worked out, and which studies are left out of them.
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