Periodontitis
Conditions
Keywords
Enamel matrix proteins, dental scaling, root planing, oral hygiene, non-surgical periodontal therapy, periodontitis
Brief summary
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.
Interventions
PROCEDUREPeriodontal non surgical treatment
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.
BEHAVIORALOral Hygiene Instructions
Patients will be motivated and instructed to improve their daily home dental plaque control through the usage of interdental devices and electric toothbrush.
PROCEDURESurgical Periodontal Treatment
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.
Sponsors
University of Pisa
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pocket Closure | 3 months and subsequent follow-ups | Percentage of affected sites (probing pocket depth ≥4 mm at baseline) that achieve a probing pocket depth \<4 mm |
| Periodontitis Patient Resolution | 3 months and subsequent follow-ups | Number and percentage of participants showing no sites with PPD\>5 mm at 3 months and subsequent re-evaluation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Probing Pocket Depth (PPD) | 3 months and subsequent follow-ups | Change in mean PPD from baseline to 3 months and subsequent re-evaluation. A decrease indicates periodontal condition improvement. |
| Change in Clinical Attachment Level (CAL) | 3 months and subsequent follow-ups | Change in mean CAL from baseline to 3 months and subsequent re-evaluation. A decrease indicates periodontal condition improvement. |
| Change in Full-Mouth Bleeding Score (FMBS) | 3 months and subsequent follow-ups | 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. |
| Change in Number of Deep Pockets | 3 months and subsequent follow-ups | 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. |
| Gingivitis Patient Resolution | 3 months and subsequent follow-ups | 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. |
| Psychometric testing and Oral Health Related Quality of Life | 3 months and subsequent follow-ups | 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. |
| Capillary blood sampling via finger prick | 3 months and subsequent follow-ups | 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. |
| Biologic fluid samples | 3 months and subsequent follow-ups | Biologic fluid samples, including saliva and peripheral blood, will be collected from study participants to support exploratory and confirmatory analyses. |
Countries
Italy
Contacts
CONTACTFilippo Graziani, Prof.
Outcome results
None listed