Non-Surgical Periodontal Treatment With an Oscillating Ultrasonic Device With Adjunctive Root Polishing. A Randomized, Comparative, Prospective Clinical Trial.

NCT07469813 | Completed

• 1 other identifier: F076730153562/16625/251HAF/IRP
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontal Disease

Keywords

periodontal disease; oscillating; hand instruments; periodontal treatment

Outcome Measures

Primary Outcomes (1)

• Probing Pocket Depth

  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 Outcomes (5)

• 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

Study Arms (2)

Group 1

ACTIVE COMPARATOR

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

Group 2

EXPERIMENTAL

Periodontal treatment with Vector/Paro

Procedure: Periodontal treatment with U/S scalers and Vector/Paro

Interventions

Periodontal treatment with U/S scalers and Vector/Paro PROCEDURE

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.

Group 2

Non-surgical periodontal treatment with U/S scalers and hand instruments PROCEDURE

Treatment of Group 1 was performed with U/S scalers (P3 \& P1), hand instruments( Gracey curettes) and sub-gingival polishing.

Group 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Systematically healthy adults
• Signed informed consent
• Periodontal disease diagnosis
• Absence of periodontal treatment the previous 12 months

You may not qualify if:

• 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

Sponsors & Collaborators

• 251 Hellenic Air Force & VA General Hospital: lead

Study Sites (1)

251 Hellenic Airforce Hospital

Athens, 11525, Greece

Location

MeSH Terms

Conditions

Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Officials

• Panagiotis Theodorelos, DDS, MSc

  251 Hellenic Airforce Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Systematically healthy adults with a periodontal disease diagnosis, but absence of any periodontal treatment in the previous 12 months were chosen. At baseline, patient's demographics were recorded together with a medical and dental history report and a panoramic X- ray was performed. Oral hygiene instructions were given individually. The clinical measurements concerning the periodontal tissues were fully recorded in a Florida Probe periodontal chart pre-therapeutically and 3 to 6 months after treatment. Subsequently, all patients received non-surgical periodontal treatment with the novel vertically oscillating ultrasonic device (Vector/Paro,Durr Dental) with adjunctive subgingival root air-polishing(Lunos Perio Combi trehalose powder).

Study Record Dates

• First Submitted: March 10, 2026
• First Posted: March 13, 2026
• Study Start: June 20, 2025
• Primary Completion: January 20, 2026
• Study Completion: January 20, 2026
• Last Updated: March 13, 2026

Record last verified: 2026-03

Locations

GR (1)