Non-Surgical Periodontal Treatment With an Oscillating Ultrasonic Device With Adjunctive Root Polishing. A Randomized, Comparative, Prospective Clinical Trial.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Probing Pocket Depth
Study Overview
Brief Summary
Non-surgical periodontal treatment leads to periodontal inflammation resolution and amelioration of the clinical periodontal indices via the microbial load reduction. Additionally, non-surgical periodontal treatment can be performed with different instruments. Ultrasonic scalers with or without hand scalers are more frequently used during Phase I periodontal treatment, however the one who performs the treatment is committed to choose the tools that according to his judgment will lead to the best clinical outcomes following non-surgical periodontal therapy. The aim of this study was to evaluate the effectiveness of non-surgical periodontal treatment with a new oscillating ultrasonic device (Paro) with adjunctive root polishing versus traditional scaling and root planing with ultrasonic device and hand instruments, 3 and 6 months after treatment, at patients diagnosed with chronic periodontitis stage II, III and IV.
Detailed Description
Non-surgical periodontal treatment leads to periodontal inflammation resolution and amelioration of the clinical periodontal indices via the microbial load reduction. Additionally, non-surgical periodontal treatment can be performed with different instruments. Ultrasonic scalers with or without hand scalers are more frequently used during Phase I periodontal treatment, however the one who performs the treatment is committed to choose the tools that according to his judgment will lead to the best clinical outcomes following non-surgical periodontal therapy. The aim of this study was to evaluate the effectiveness of non-surgical periodontal treatment with a new oscillating ultrasonic device (Paro) with adjunctive root polishing versus traditional scaling and root planing with ultrasonic device and hand instruments, 3 and 6 months after treatment, at patients diagnosed with chronic periodontitis stage II, III and IV.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Systematically healthy adults
- •Signed informed consent
- •Periodontal disease diagnosis
- •Absence of periodontal treatment the previous 12 months
Exclusion Criteria
- •Medical history that interferes with the healing process (CVD, organ transplantation, renal or hepatic failure etc)
- •Antibiotic and anti-inflammatory intake up to 1 month before treatment initiation
- •Pharmaceutically induced gingival enlargement
- •Pregnancy/ lactation
Arms & Interventions
Group 1
Conventional Periodontal Treatment, scaling and root planing with ultrasonic device and hand instruments
Intervention: Non-surgical periodontal treatment with U/S scalers and hand instruments (Procedure)
Group 2
Periodontal treatment with Vector/Paro
Intervention: Periodontal treatment with U/S scalers and Vector/Paro (Procedure)
Outcomes
Primary Outcomes
Probing Pocket Depth
Time Frame: From enrollment to the end of post-treatment monitoring at 6 months
Measurement from Free Gingival Margin to the base of the sulcus/pocket, in millimeters
Secondary Outcomes
- Clinical Attachment Levels(From enrollment to the end of post-treatment monitoring at 6 months)
- Bleeding on probing(From enrollment to the end of post-treatment monitoring at 6 months)
- Root Dentin Hypersensitivity(From enrollment to the end of post-treatment monitoring at 6 months)
- Pain perception after treatment(From enrollment to the end of post-treatment monitoring at 6 months)
- Recession(From enrollment to the end of post-treatment monitoring at 6 months)