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

Not Applicable

Recruiting

• Conditions: Periodontitis

• Registration Number: NCT06366295
• Lead Sponsor: Medical University of Warsaw

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.

Study Timeline

• Status Verified: 2023-06
• Study Start: 2023-06-01
• Primary Completion: 2024-04
• Study First Submitted: 2024-04-10
• Study First Submitted QC: 2024-04-12
• Study First Posted: 2024-04-15
• Last Update Submitted: 2024-04-15
• Last Update Posted: 2024-04-17
• Study Completion: 2024-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Probing pocket depth (PPD)	0 (before), 3 and 6 months after SRP	Distance from the gingival margin to the bottom of the gingival sulcus
Clinical attachment level (CAL)	0 (before), 3 and 6 months after SRP	Distance from the cementoenamel junction to the bottom of the gingival sulcus
Bleeding on probing (BoP)	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)	0 (before), 3 and 6 months after SRP	Percentage of sites with plaque

Secondary Outcome Measures

Name	Time	Method
Gingival thickness (GT)	0 (before), 3 and 6 months after SRP	Thickness of the gingiva measured 2 mm apical to the gingival margin
Width of keratinized tissue (KTW)	0 (before), 3 and 6 months after SRP	Distance between the most apical point of gingival margin and the mucogingival junction

Trial Locations

Locations (1)

Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw; 🇵🇱 Warsaw, Mazowieckie, Poland