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

251 Hellenic Air Force & VA General Hospital

Status: Completed

Conditions: Periodontal Disease

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07469813

F076730153562/16625/251HAF/IRP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Group 1

Active Comparator group

Description:

Conventional Periodontal Treatment, scaling and root planing with ultrasonic device and hand instruments

Treatment:

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

Group 2

Experimental group

Description:

Periodontal treatment with Vector/Paro

Treatment:

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