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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Periodontitis
• Intervention / Treatment: Device: subgingival mechanotherapy with perioscopy; Device: classical subgingival mechanotherapy

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 Type: Interventional
• Enrollment (Estimated): 26
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Karolina Grzywacka; Phone Number: +48796137960; Email: k.grzywacka@gmail.com
• Study Contact Backup: Name: Bartlomiej Górski, PhD; Phone Number: +48 22 116 64 31; Email: bartlomiej.gorski@wum.edu.pl

Study Locations

• Poland
  • Mazowieckie
    • Warsaw, Mazowieckie, Poland, 02-097
      • Recruiting
      • Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw
      • Contact: Bartlomiej Gorski, DDS, PhD; Phone Number: +48 22 502 20 99; Email: bartlomiej.gorski@wum.edu.pl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: subgingival mechanotherapy with perioscopy; Subgingival mechanotherapy using a machine scaler, curettes and a perioscope
Active Comparator: Classical subgingival mechanotherapy; Scaling and root planing using ultrasonic scaler and curettes.	Device: classical subgingival mechanotherapy; Subgingival mechanotherapy using a machine scaler and curettes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Probing pocket depth (PPD)	Distance from the gingival margin to the bottom of the gingival sulcus	0 (before), 3 and 6 months after SRP
Clinical attachment level (CAL)	Distance from the cementoenamel junction to the bottom of the gingival sulcus	0 (before), 3 and 6 months after SRP
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
Plaque index (PI)	Percentage of sites with plaque	0 (before), 3 and 6 months after SRP

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Gingival thickness (GT)	Thickness of the gingiva measured 2 mm apical to the gingival margin	0 (before), 3 and 6 months after SRP

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Gingival crevicular fluid levels of cytokines	Levels of (IL - interleukin) IL-1β, 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

Collaborators and Investigators

• Sponsor: Medical University of Warsaw
• Investigators: Principal Investigator: Bartlomiej Górski, PhD, Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): November 1, 2024

Study Registration Dates

• First Submitted: April 10, 2024
• First Submitted That Met QC Criteria: April 12, 2024
• First Posted (Actual): April 15, 2024

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 15, 2024
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: periodontal endoscopy, perioscopy
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis
• Other Study ID Numbers: WUM.Perio.05

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No