Non-Surgical Periodontal Treatment With an Oscillating Ultrasonic Device With Adjunctive Root Polishing. A Randomized, Comparative, Prospective Clinical Trial.
March 10, 2026 updated by: 251 Hellenic Air Force & VA General Hospital
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 Overview
Status
Completed
Conditions
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 Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Athens, Greece, 11525
- 251 Hellenic Airforce Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Group 1
Conventional Periodontal Treatment, scaling and root planing with ultrasonic device and hand instruments
|
Treatment of Group 1 was performed with U/S scalers (P3 & P1), hand instruments( Gracey curettes) and sub-gingival polishing.
|
|
Experimental: Group 2
Periodontal treatment with Vector/Paro
|
Treatment of Group 2 was performed with U/S scalers (P3 & P1), Vector-Paro System and sub- gingival polishing.
In both groups, completion was decided upon the feeling of the operator that the root surfaces are smooth enough.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
From enrollment to the end of post-treatment monitoring at 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinical Attachment Levels
Time Frame: From enrollment to the end of post-treatment monitoring at 6 months
|
DIstance from cementoenamel junction to the base of sulcus/pocket, in millimeters
|
From enrollment to the end of post-treatment monitoring at 6 months
|
|
Bleeding on probing
Time Frame: From enrollment to the end of post-treatment monitoring at 6 months
|
Presence/Absence of bleeding on probing
|
From enrollment to the end of post-treatment monitoring at 6 months
|
|
Root Dentin Hypersensitivity
Time Frame: From enrollment to the end of post-treatment monitoring at 6 months
|
Feeling of sensitivity to cold stimuli measured with VAS scale
|
From enrollment to the end of post-treatment monitoring at 6 months
|
|
Pain perception after treatment
Time Frame: From enrollment to the end of post-treatment monitoring at 6 months
|
Feeling of pain after treatmetn measured in VAS scale
|
From enrollment to the end of post-treatment monitoring at 6 months
|
|
Recession
Time Frame: From enrollment to the end of post-treatment monitoring at 6 months
|
Distance from cemento-enamel junction to the free gingival margin in millimeters
|
From enrollment to the end of post-treatment monitoring at 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Panagiotis Theodorelos, DDS, MSc, 251 Hellenic Airforce Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 20, 2025
Primary Completion (Actual)
January 20, 2026
Study Completion (Actual)
January 20, 2026
Study Registration Dates
First Submitted
March 10, 2026
First Submitted That Met QC Criteria
March 10, 2026
First Posted (Actual)
March 13, 2026
Study Record Updates
Last Update Posted (Actual)
March 13, 2026
Last Update Submitted That Met QC Criteria
March 10, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- F076730153562/16625/251HAF/IRP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.