Comparison of Subgingival Mechanotherapy With and Without the Use of a Perioscope: Clinical Trial

NCT ID: NCT06366295

Last Updated: 2024-04-17

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-01

Study Completion Date

2024-11-30

Brief Summary

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The study aims to comparatively assess clinical parameters, biochemical and microbiological parameters after treatment of periodontitis using subgingival mechanotherapy traditional and subgingival mechanotherapy using a perioscope.

Detailed Description

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Non-surgical treatment is the basic form of disease treatment periodontitis. Its first stage is the mechanical removal of dental plaque along with the control of risk factors. Subgingival mechanotherapy, also known as scaling and root planing (SRP) is the next stage, aimed at the subgingival area. Perioscopy makes possible direct real-time visualization of the root surface during the procedure. The research results published so far indicate improvement or no significant differences clinical parameters after SRP procedure using a perioscope vs traditional subgingival instrumentation. The aim of this study is to indicate, or not, clinical, biochemical (level of pro-inflammatory cytokines) and microbiological (A. actinomycetemcomitans, P. gingivalis, T. denticola) differences after periodontitis treatment using the traditional method vs. using a perioscope.

Conditions

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Periodontitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Subgingival mechanotherapy with perioscopy

Scaling and root planing using ultrasonic scaler and curettes, under the control of a perioscope, enabling real-time, magnified imaging of the root surface.

Group Type EXPERIMENTAL

subgingival mechanotherapy with perioscopy

Intervention Type DEVICE

Subgingival mechanotherapy using a machine scaler, curettes and a perioscope

Classical subgingival mechanotherapy

Scaling and root planing using ultrasonic scaler and curettes.

Group Type ACTIVE_COMPARATOR

classical subgingival mechanotherapy

Intervention Type DEVICE

Subgingival mechanotherapy using a machine scaler and curettes

Interventions

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subgingival mechanotherapy with perioscopy

Subgingival mechanotherapy using a machine scaler, curettes and a perioscope

Intervention Type DEVICE

classical subgingival mechanotherapy

Subgingival mechanotherapy using a machine scaler and curettes

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* age 20-60; (II)
* preserved lateral and anterior teeth;
* no periodontal treatment in the last 12 months;
* intermediate or advanced periodontitis (Stage II / III / IV)
* in each quadrant at least three teeth with PPD\>5 mm after initial treatment (scaling, motivation, instruction)

Exclusion Criteria

* antibiotic therapy in the last 6 months;
* smoking;
* systemic diseases affecting periodontal tissues;
* pregnancy or lactation;
* orthodontic treatment;
* tooth mobility II / III degree;
* involvement of third degree furcations according to Hamp classification;
* endodontic issues
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Warsaw

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bartlomiej Górski, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw

Locations

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Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw

Warsaw, Masovian Voivodeship, Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Karolina Grzywacka

Role: CONTACT

+48796137960

Bartlomiej Górski, PhD

Role: CONTACT

+48 22 116 64 31

Facility Contacts

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Bartlomiej Gorski, DDS, PhD

Role: primary

+48 22 502 20 99

Other Identifiers

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WUM.Perio.05

Identifier Type: -

Identifier Source: org_study_id

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