Impact of Non-surgical Periodontal Treatment of miRNome

NCT ID: NCT06382935

Last Updated: 2024-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-20

Study Completion Date

2024-10-15

Brief Summary

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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 miRNome in gingival crevicular fluid

Detailed Description

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A double-blind randomized-controlled clinical trial is conducted in order to evaluate the impact of non-surgical periodontal treatment in subjects with periodontitis.

60 patients: 30 with periodontitis and 30 healthy controls. All the patients are assessed for clinical, periodontal, blood following of minimally invasive approach MINST or Q-SI (quadrantwise).

Measurements are taken before and after initial periodontal treatment in the periodontal subjects.

Conditions

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Periodontitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Non-surgical periodontal treatment Subgingival biofilm ultrasonic debridement with MINST or Q-SI
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
Sealed envelopes

Study Groups

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MINST non surgical periodontal treatment

Periodontitis patients treated by means of MINST. Patients were treated with non-surgical MINST periodontal treatment in a single session.

Group Type EXPERIMENTAL

Probin Pocket Depth reduction

Intervention Type OTHER

Probin Pocket Depth reduction in millimetres before and after treatment

Q-SI non surgical periodontal treatment

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

Group Type ACTIVE_COMPARATOR

Probin Pocket Depth reduction

Intervention Type OTHER

Probin Pocket Depth reduction in millimetres before and after treatment

Interventions

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Probin Pocket Depth reduction

Probin Pocket Depth reduction in millimetres before and after treatment

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of Periodontitis

Exclusion Criteria

* Periodontal treatment
* Use of antibiotics, NSAIDs, and immunosuppressants during the last 6 months
* Pregnancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Catania

OTHER

Sponsor Role lead

Responsible Party

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Gaetano Isola

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gaetano Isola

Role: PRINCIPAL_INVESTIGATOR

Università degli Studi di Catania

Locations

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AOU Policlinico G. Rodolico

Catania, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Gaetano Isola

Role: CONTACT

0953785652

Rosalia Leonardi

Role: CONTACT

0953785652

Facility Contacts

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Gaetano Isola, DDS

Role: primary

0953785652

Other Identifiers

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34-24

Identifier Type: -

Identifier Source: org_study_id

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