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

Intervention / Treatment

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

  • Greece
      • 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:

  1. Systematically healthy adults
  2. Signed informed consent
  3. Periodontal disease diagnosis
  4. Absence of periodontal treatment the previous 12 months

Exclusion Criteria:

  1. Medical history that interferes with the healing process (CVD, organ transplantation, renal or hepatic failure etc)
  2. Antibiotic and anti-inflammatory intake up to 1 month before treatment initiation
  3. Pharmaceutically induced gingival enlargement
  4. 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
Procedure: Non-surgical periodontal treatment with U/S scalers 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
Procedure: Periodontal treatment with U/S scalers and 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.

Sponsor

251 Hellenic Air Force & VA General Hospital

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

Keywords

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.

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