Clinical trial NCT06366295: Comparison of Subgingival Mechanotherapy With and Without the Use of a Perioscope: Clinical Trial
Official title: Subgingival Mechanotherapy Using a Periodontal Endoscope Compared to Classical Subgingival Mechanotherapy for the Treatment of Periodontitis: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Periodontitis
Keywords: periodontal endoscopy, perioscopy
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2024-04-15
Enrollment: 26
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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;
* 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

Primary outcomes:
measure: Probing pocket depth (PPD)
timeFrame: 0 (before), 3 and 6 months after SRP
measure: Clinical attachment level (CAL)
timeFrame: 0 (before), 3 and 6 months after SRP
measure: Bleeding on probing (BoP)
timeFrame: 0 (before), 3 and 6 months after SRP
measure: Plaque index (PI)
timeFrame: 0 (before), 3 and 6 months after SRP
Secondary outcomes:
measure: Width of keratinized tissue (KTW)
timeFrame: 0 (before), 3 and 6 months after SRP
measure: Gingival thickness (GT)
timeFrame: 0 (before), 3 and 6 months after SRP
Other outcomes:
measure: Subgingival plaque pathogens (Aa, Pg, Td) levels
timeFrame: 0 (before) and 6 months after SRP
measure: Gingival crevicular fluid levels of cytokines
timeFrame: 0 (before), 3 and 6 months after SRP
Locations:
city: Warsaw
country: Poland
facility: Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw
state: Mazowieckie
Study officials:
affiliation: Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw
name: Bartlomiej Górski, PhD
role: PRINCIPAL_INVESTIGATOR
References: