Subgingival Mechanotherapy Using a Periodontal Endoscope Compared to Classical Subgingival Mechanotherapy for the Treatment of Periodontitis: a Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 26
- Locations
- 2
- Primary Endpoint
- Probing pocket depth (PPD)
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 20 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Classical subgingival mechanotherapy
Scaling and root planing using ultrasonic scaler and curettes.
Intervention: classical subgingival mechanotherapy (Device)
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.
Intervention: subgingival mechanotherapy with perioscopy (Device)
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)