Minimally Non Surgical Periodontal Therapy Compared to Traditional Approach

NCT05060601 | Not Yet Recruiting

• 1 other identifier: 465/20
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to evaluate the clinical results of non-surgical periodontal therapy performed with micro-instruments compared to traditional approach (standard curettes) after 6 months of follow-up. The patients enrolled, subject to written informed consent, will be divided into a Test group (T) and a Control group (C) through a randomization process. Both groups will be motivated on the rules of oral hygiene, treated scrupulously and monitored monthly for 6 months, at the end of which the final data will be collected for statistical processing (in particular by analyzing the difference between baseline and after 6 months of the parameter "probing depth" or PD).

Conditions

Periodontal Diseases; Periodontal Inflammation

Keywords

Periodontitis; Osseous defects; Periodontal therapy

Outcome Measures

Primary Outcomes (1)

• Change of Probing Depth (PD) (millimeters)

  The distance from gingival margin to the bottom of the pocket

  baseline, 1 week after supragingival scaling, 6 months after non-surgical periodontal therapy

Secondary Outcomes (4)

• Change of Full-Mouth Plaque Score (FMPS) (percentage)

  baseline, 1 week after supragingival scaling, 6 months after non-surgical periodontal therapy

• Change of Full-Mouth Bleeding Score (FMBS) (percentage)

  baseline, 1 week after supragingival scaling, 6 months after non-surgical periodontal therapy

• Change of Clinical Attachment Level (CAL) (millimeters)

  baseline, 1 week after supragingival scaling, 6 months after non-surgical periodontal therapy

• Change of Gingival Recession (GR) (millimeters)

  baseline, 1 week after supragingival scaling, 6 months after non-surgical periodontal therapy

Study Arms (2)

Gracey micro-curettes

EXPERIMENTAL

Subgingival mechanical debridement will be performed using an ultrasonic scaler with specific thin tips and Gracey micro-curette.

Procedure: Gracey micro-curettes

Standard Gracey curettes

ACTIVE COMPARATOR

Subgingival mechanical debridement will be performed using a conventional ultrasonic scaler and standard Gracey curettes.

Procedure: Standard Gracey curettes

Interventions

Gracey micro-curettes PROCEDURE

Mechanical debridement will be performed by means of ultrasonic scalers with specific thin tips and micro-curettes, in order to minimize trauma for gingival tissues.

Gracey micro-curettes

Standard Gracey curettes PROCEDURE

After local anaesthesia, non surgical subgingival debridement will be performed by standard Gracey curettes

Standard Gracey curettes

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Untreated patients diagnosed with severe/advanced periodontitis with slow/moderate rate of progression
• Age \> 18 years
• Patients at least 10 teeth per arch
• Presence at least of two teeth with PD \> 5 mm per quadrant
• Single-rooted teeth or multi-rooted without furcation involvement

You may not qualify if:

• Patients with systemic diseases
• Pregnant or lactating
• Tobacco smokers (\<10 cigarettes/day)
• Previous periodontal treatment in the last 2 years
• Prolonged antibiotic treatment or anti-inflammatory treatment within 6 months prior to periodontal therapy
• Furcation involvement
• Acute periodontal or endodontic abscesses
• Third molars

Sponsors & Collaborators

• Federico II University: lead

MeSH Terms

Conditions

Periodontal Diseases; Periodontitis

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Luca Ramaglia

Study Record Dates

• First Submitted: September 6, 2021
• First Posted: September 29, 2021
• Study Start: March 1, 2024
• Primary Completion: September 1, 2024
• Study Completion: October 1, 2024
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share