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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07469813
Enrollment
40
Registered
2026-03-13
Start date
2025-06-20
Completion date
2026-01-20
Last updated
2026-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periodontal Disease

Keywords

periodontal disease, oscillating, hand instruments, periodontal treatment

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.

Interventions

PROCEDURENon-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.

PROCEDUREPeriodontal 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.

Sponsors

251 Hellenic Air Force & VA General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Intervention model description

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).

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Probing Pocket DepthFrom enrollment to the end of post-treatment monitoring at 6 monthsMeasurement from Free Gingival Margin to the base of the sulcus/pocket, in millimeters

Secondary

MeasureTime frameDescription
Clinical Attachment LevelsFrom enrollment to the end of post-treatment monitoring at 6 monthsDIstance from cementoenamel junction to the base of sulcus/pocket, in millimeters
Bleeding on probingFrom enrollment to the end of post-treatment monitoring at 6 monthsPresence/Absence of bleeding on probing
Root Dentin HypersensitivityFrom enrollment to the end of post-treatment monitoring at 6 monthsFeeling of sensitivity to cold stimuli measured with VAS scale
Pain perception after treatmentFrom enrollment to the end of post-treatment monitoring at 6 monthsFeeling of pain after treatmetn measured in VAS scale
RecessionFrom enrollment to the end of post-treatment monitoring at 6 monthsDistance from cemento-enamel junction to the free gingival margin in millimeters

Countries

Greece

Contacts

PRINCIPAL_INVESTIGATORPanagiotis Theodorelos, DDS, MSc

251 Hellenic Airforce Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 14, 2026