NCT07507474

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
54mo left

Started Dec 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress36%
Dec 2023Dec 2030

Study Start

First participant enrolled

December 5, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 5, 2025

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 27, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 2, 2026

Completed
4.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2030

Expected
Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

1.6 years

First QC Date

March 27, 2026

Last Update Submit

April 27, 2026

Conditions

Periodontitis

Keywords

Enamel matrix proteinsdental scalingroot planingoral hygienenon-surgical periodontal therapyperiodontitis

Outcome Measures

Primary Outcomes (2)

  • Pocket Closure

    Percentage of affected sites (probing pocket depth ≥4 mm at baseline) that achieve a probing pocket depth \<4 mm

    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

    3 months and subsequent follow-ups

Secondary Outcomes (8)

  • Change in Probing Pocket Depth (PPD)

    3 months and subsequent follow-ups

  • Change in Clinical Attachment Level (CAL)

    3 months and subsequent follow-ups

  • Change in Full-Mouth Bleeding Score (FMBS)

    3 months and subsequent follow-ups

  • Change in Number of Deep Pockets

    3 months and subsequent follow-ups

  • Gingivitis Patient Resolution

    3 months and subsequent follow-ups

  • +3 more secondary outcomes

Interventions

Periodontal non surgical treatmentPROCEDURE

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
Oral Hygiene InstructionsBEHAVIORAL

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

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

adult patients diagnosed with periodontitis

You may qualify if:

  • 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

You may not qualify if:

  • Pregnancy or breastfeeding
  • Patients previously treated for periodontitis
  • Poorly controlled systemic conditions
  • Refusal to participate
  • Patients who did not complete the proposed treatment plan

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pisa

Pisa, None Selected, 56126, Italy

RECRUITING

MeSH Terms

Conditions

Periodontitis

Interventions

Tooth ExfoliationRoot Planing

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Physiological PhenomenaDigestive System and Oral Physiological PhenomenaDental ScalingDental ProphylaxisPeriodonticsDentistrySubgingival CurettagePreventive Dentistry

Central Study Contacts

Filippo Graziani, Prof.

CONTACT

+393384014984filippo.graziani@unipi.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor, DMD, MClinDent, PhD

Study Record Dates

First Submitted

March 27, 2026

First Posted

April 2, 2026

Study Start

December 5, 2023

Primary Completion

July 5, 2025

Study Completion (Estimated)

December 5, 2030

Last Updated

May 1, 2026

Record last verified: 2026-04

Locations

IT(1)