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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
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.

Filippo Graziani, Prof. contact

+393384014984

filippo.graziani@unipi.it

Italy1 site, 1 recruiting
  • University of Pisa

    Pisa, None Selected, 56126

    Filippo Graziani, filippograziani@med.unipi.it

    rossana.izzetti@unipi.it

    Recruiting

Other trials in Italy

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.

  1. 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

  2. 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)
  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.

    Measured: 3 months and subsequent follow-ups

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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.

  1. First posted2 Apr 2026
  2. Study start5 Dec 2023
  3. Primary completion5 Jul 2025
  4. Study completion5 Dec 2030 (estimated)

Resources

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)
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

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.

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