Performance of the Treatment of Periodontitis According to the Bioperio® Protocol
ConditionPeriodontitis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Pisa
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Pregnancy or breastfeeding
Patients previously treated for periodontitis
Poorly controlled systemic conditions
Refusal to participate
Trial population
adult patients diagnosed with periodontitis
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Periodontal non surgical treatment
Procedure/SurgeryNon 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.
Oral Hygiene Instructions
BehavioralPatients 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/SurgeryIn 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.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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-ups2
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-upsSecondary outcomes
1
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-ups2
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-ups3
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-ups4
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-upsSponsors and contacts
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Source ClinicalTrials.gov