NCT06993519

Brief Summary

A double-blind randomized-controlled clinical trial is conducted in order to evaluate the impact of non-surgical periodontal treatment by means of minimally invasive approach MINST or Q-SI (quadrantwise) approach in subjects with periodontitis on residual pockets after active periodontal treatment

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2021

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 19, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 29, 2025

Completed
Last Updated

May 29, 2025

Status Verified

May 1, 2025

Enrollment Period

4.2 years

First QC Date

May 19, 2025

Last Update Submit

May 19, 2025

Conditions

Pocket, PeriodontalPeriodontitis

Outcome Measures

Primary Outcomes (1)

  • Probin Pocket Depth reduction

    Probin Pocket Depth reduction in millimetres before and after treatment

    1-year

Study Arms (2)

MINST non surgical periodontal treatment

EXPERIMENTAL

Patients were treated with non-surgical MINST periodontal treatment in a single session on residual pockets

Other: Probin Pocket Depth reduction

Q-SI non surgical periodontal treatment

ACTIVE COMPARATOR

Periodontitis patients treated by means of Q-SI. Patients were treated with non-surgical quadrantwise periodontal treatment in 4 sessions, 1 session per week on residual pockets

Other: Probin Pocket Depth reduction

Interventions

Probin Pocket Depth reductionOTHER

Probin Pocket Depth reduction in millimetres before and after treatment

MINST non surgical periodontal treatmentQ-SI non surgical periodontal treatment

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of Periodontitis
  • Presence of residula periodontal pockets

You may not qualify if:

  • Periodontal treatment
  • Use of antibiotics, NSAIDs, and immunosuppressants during the last 6 months
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Policlinico G. Rodolico

Catania, 95124, Italy

Location

MeSH Terms

Conditions

Periodontal PocketPeriodontitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Gaetano Isola, DDS

    Università degli Studi di Catania - Dipartimento di Chirurgia Generale e Specialità Medico-Chirurgiche

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
Sealed envelopes
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Non-surgical periodontal treatment Subgingival biofilm ultrasonic debridement with MINST or Q-SI for residual pockets
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 19, 2025

First Posted

May 29, 2025

Study Start

January 2, 2021

Primary Completion

April 1, 2025

Study Completion

April 10, 2025

Last Updated

May 29, 2025

Record last verified: 2025-05

Locations

IT(1)