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

Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06366295
• Other study ID #: WUM.Perio.05
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: November 2024

Study information

• Verified date: June 2023
• Source: Medical University of Warsaw
• Contact: Karolina Grzywacka
• Phone: +48796137960
• Email: k.grzywacka[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 26
• Est. completion date: November 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Periodontitis

Intervention

Device:
• subgingival mechanotherapy with perioscopy
Subgingival mechanotherapy using a machine scaler, curettes and a perioscope
• classical subgingival mechanotherapy
Subgingival mechanotherapy using a machine scaler and curettes

Locations

Country	Name	City	State
Poland	Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw	Warsaw	Mazowieckie

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Subgingival plaque pathogens (Aa, Pg, Td) levels	Levels of periodontal pathogens (Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Treponema denticola) measured with real-time polymerase chain reaction (RT-PCR) test; data presented as number of bacteria of these species and percentage of total bacteria found in a sample; sample taken from the deepest pocket on each side.	0 (before) and 6 months after SRP
Other	Gingival crevicular fluid levels of cytokines	Levels of (IL - interleukin) IL-1ß, IL-6, IL-8, IL-10 and interferon-gamma in gingival crevicular fluid presented as pg/ml; sample taken from the deepest pocket on each side.	0 (before), 3 and 6 months after SRP
Primary	Probing pocket depth (PPD)	Distance from the gingival margin to the bottom of the gingival sulcus	0 (before), 3 and 6 months after SRP
Primary	Clinical attachment level (CAL)	Distance from the cementoenamel junction to the bottom of the gingival sulcus	0 (before), 3 and 6 months after SRP
Primary	Bleeding on probing (BoP)	Percentage of sites with bleeding provoked by applying a probe to the bottom of a sulcus/pocket.	0 (before), 3 and 6 months after SRP
Primary	Plaque index (PI)	Percentage of sites with plaque	0 (before), 3 and 6 months after SRP
Secondary	Width of keratinized tissue (KTW)	Distance between the most apical point of gingival margin and the mucogingival junction	0 (before), 3 and 6 months after SRP
Secondary	Gingival thickness (GT)	Thickness of the gingiva measured 2 mm apical to the gingival margin	0 (before), 3 and 6 months after SRP