PeriodontitisBIOPERIONCT07507474
Performance of the Treatment of Periodontitis According to the Bioperio® Protocol
An observational study of Periodontitis, run by University of Pisa at 1 site in Italy.
Trial summary
This multicenter, prospective, single-arm observational study evaluated the clinical performance of the Bioperio® protocol, a standardized, patient-centered framework for managing periodontitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periodontitis
- What is being tested?
- Periodontal non surgical treatment, Oral Hygiene Instructions and Surgical Periodontal Treatment
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure, Lifestyle or therapy programme
- How many people
- 5,000 participants
- Where
- 1 siteItaly
- Study dates
- 5 Dec 2023to 5 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adult patients diagnosed with periodontitis
Who may be able to join
- 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
Who cannot join
- Pregnancy or breastfeeding
- Patients previously treated for periodontitis
- Poorly controlled systemic conditions
- Refusal to participate
- Patients who did not complete the proposed treatment plan
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
University of Pisa
Pisa, None Selected, 56126
Filippo Graziani, filippograziani@med.unipi.it
rossana.izzetti@unipi.it
About this study
Official title: 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.
- Conditions
- Periodontitis
- Being tested
- Periodontal non surgical treatment, Oral Hygiene Instructions, Surgical Periodontal Treatment
- Keywords
- Enamel matrix proteins, dental scaling, root planing, oral hygiene, non-surgical periodontal therapy, periodontitis
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periodontal non surgical treatmentProcedure or surgery
Also called Scaling and root planing
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.
Oral Hygiene InstructionsBehavioural
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 TreatmentProcedure or surgery
Also called periodontal surgery
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Pocket Closure
Percentage of affected sites (probing pocket depth ≥4 mm at baseline) that achieve a probing pocket depth <4 mm
Measured: 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
Measured: 3 months and subsequent follow-ups
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months and subsequent follow-ups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2026
- Study start5 Dec 2023
- Primary completion5 Jul 2025
- Study completion5 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pisa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Filippo Graziani, DDS MClinDent PhD, University of Pisa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07507474
- Sponsor's protocol ID
- BIOPERIO
- Acronym
- BIOPERIO
- Status last verified
- Apr 2026
- First submitted
- 27 Mar 2026
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance of the Treatment of Periodontitis According to the Bioperio® Protocol: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07507474
- Acronym / sponsor ID
- BIOPERIO / BIOPERIO
- Conditions
- Periodontitis
- Keywords
- Enamel matrix proteins, dental scaling, root planing, oral hygiene, non-surgical periodontal therapy, periodontitis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- University of PisaUniversity, hospital or other
- Study start
- 5 Dec 2023 (actual)
- Primary completion
- 5 Jul 2025 (actual)
- Study completion
- 5 Dec 2030 (estimated)
- First posted
- 2 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult patients diagnosed with periodontitis
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- Pregnancy or breastfeeding
- Patients previously treated for periodontitis
- Poorly controlled systemic conditions
- Refusal to participate
- Patients who did not complete the proposed treatment plan
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Periodontal non surgical treatmentAlso: Scaling and root planingNon 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. | Procedure or surgery | – |
| Oral Hygiene InstructionsPatients will be motivated and instructed to improve their daily home dental plaque control through the usage of interdental devices and electric toothbrush. | Behavioural | – |
| Surgical Periodontal TreatmentAlso: periodontal 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. | Procedure or surgery | – |
Primary outcome
Pocket Closure
Time frame: 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
Time frame: 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
8 secondary outcomes
Change in Probing Pocket Depth (PPD)
Time frame: 3 months and subsequent follow-ups
Change in Clinical Attachment Level (CAL)
Time frame: 3 months and subsequent follow-ups
Change in Full-Mouth Bleeding Score (FMBS)
Time frame: 3 months and subsequent follow-ups
Change in Number of Deep Pockets
Time frame: 3 months and subsequent follow-ups
Gingivitis Patient Resolution
Time frame: 3 months and subsequent follow-ups
Psychometric testing and Oral Health Related Quality of Life
Time frame: 3 months and subsequent follow-ups
Capillary blood sampling via finger prick
Time frame: 3 months and subsequent follow-ups
Biologic fluid samples
Time frame: 3 months and subsequent follow-ups
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontitis, run by University of Pisa at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Filippo Graziani, Prof. (+393384014984, filippo.graziani@unipi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pocket Closure (time frame: 3 months and subsequent follow-ups). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.