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Clinical Trials/NCT06366295
NCT06366295
Recruiting
Not Applicable

Subgingival Mechanotherapy Using a Periodontal Endoscope Compared to Classical Subgingival Mechanotherapy for the Treatment of Periodontitis: a Randomized Clinical Trial

Medical University of Warsaw1 site in 1 country26 target enrollmentJune 1, 2023
ConditionsPeriodontitis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Periodontitis
Sponsor
Medical University of Warsaw
Enrollment
26
Locations
1
Primary Endpoint
Probing pocket depth (PPD)
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2023
End Date
November 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Medical University of Warsaw
Responsible Party
Sponsor

Eligibility Criteria

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;
  • 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

Outcomes

Primary Outcomes

Probing pocket depth (PPD)

Time Frame: 0 (before), 3 and 6 months after SRP

Distance from the gingival margin to the bottom of the gingival sulcus

Clinical attachment level (CAL)

Time Frame: 0 (before), 3 and 6 months after SRP

Distance from the cementoenamel junction to the bottom of the gingival sulcus

Bleeding on probing (BoP)

Time Frame: 0 (before), 3 and 6 months after SRP

Percentage of sites with bleeding provoked by applying a probe to the bottom of a sulcus/pocket.

Plaque index (PI)

Time Frame: 0 (before), 3 and 6 months after SRP

Percentage of sites with plaque

Secondary Outcomes

  • Gingival thickness (GT)(0 (before), 3 and 6 months after SRP)
  • Width of keratinized tissue (KTW)(0 (before), 3 and 6 months after SRP)

Study Sites (1)

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