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

M

Medical University of Warsaw

Status

Enrolling

Conditions

Periodontitis

Treatments

Device: subgingival mechanotherapy with perioscopy
Device: classical subgingival mechanotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT06366295
WUM.Perio.05

Details and patient eligibility

About

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.

Full description

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.

Enrollment

26 estimated patients

Sex

All

Ages

20 to 60 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

26 participants in 2 patient groups

Subgingival mechanotherapy with perioscopy
Experimental group
Description:
Scaling and root planing using ultrasonic scaler and curettes, under the control of a perioscope, enabling real-time, magnified imaging of the root surface.
Treatment:
Device: subgingival mechanotherapy with perioscopy
Classical subgingival mechanotherapy
Active Comparator group
Description:
Scaling and root planing using ultrasonic scaler and curettes.
Treatment:
Device: classical subgingival mechanotherapy

Trial contacts and locations

1

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Central trial contact

Bartlomiej Górski, PhD; Karolina Grzywacka

Data sourced from clinicaltrials.gov

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