Non-Surgical Periodontal Treatment With an Oscillating Ul... | NCT07469813

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

NCT07469813

Sponsor

251 Hellenic Air Force & VA General Hospital

Status

Completed

Last Update Posted

Mar 13, 2026Actual

Enrollment

40Actual

Phase

Not Applicable

Conditions

Periodontal Disease

Interventions

Non-surgical periodontal treatment with U/S scalers and hand instruments
Periodontal treatment with U/S scalers and Vector/Paro

Countries

Greece

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 20, 2025Actual

Primary Completion Date

Jan 20, 2026Actual

Completion Date

Jan 20, 2026Actual

First Submitted Date

Mar 10, 2026

First Submission Date that Met QC Criteria

Mar 10, 2026

First Posted Date

Mar 13, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 10, 2026

Last Update Posted Date

Mar 13, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Clinical Attachment Levels	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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Panagiotis Theodorelos, DDS, MSc	251 Hellenic Airforce Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
251 Hellenic Airforce Hospital		Athens		11525	Greece

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

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).

ID	Term
D009059	Mouth Diseases
D009057	Stomatognathic Diseases