Minimally Non Surgical Periodontal Therapy Compared to Traditional Approach

Healing of Periodontal Pockets Following Treatment With Minimally Non Surgical Approach or Conventional Non Surgical Therapy. A Randomized Controlled Clinical Trial

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Periodontal Diseases; Periodontal Inflammation
• Intervention / Treatment: Procedure: Gracey micro-curettes; Procedure: Standard Gracey curettes

Detailed Description

The aim of the study is to evaluate the clinical results of non-surgical periodontal therapy performed with micro-instruments (micro-curettes) compared to traditional instruments (standard curettes) after 6 months of follow-up.

The proposed clinical trial will be conducted according to the principles of the Declaration of Helsinki on experimentation involving human subjects.

All subjects will be recruited from the Area of Odontostomatology - Department of Neuroscience, Reproductive and Odontostomatological Sciences of the University of Naples "Federico II".

In a first phase, all patients will be treated with a supragingival scaling session in order to remove plaque and tartar and it will be provided instructions for a correct oral hygiene. After 1 week, the clinical parameters (PD, FMPS, FMBS, CAL, REC) will be recorded and the subjects randomly assigned to the Test (T) or Control (C) group.

In the Test group, after local anesthesia, subgingival mechanical debridement will be performed using an ultrasonic scaler with specific thin tips and Gracey micro-curette to minimize soft tissue trauma.

In the Control group, after local anesthesia, debridement will be performed using an ultrasonic scaler with specific thin tips and standard Gracey curettes.

At the end of the periodontal therapy, a polishing paste will be applied supragingival in both groups using a rubber cup. An antiseptic therapy based on mouthwash with chlorhexidine digluconate 0.12% (two rinses a day for the first two weeks) will then be recommended. No antibiotics will be prescribed.

Patients from both groups will be called up every month for a professional supragingival cleaning and professional motivation. The final evaluation will be carried out 6 months after the subgingival treatment.

Data analysis will be performed using statistical software (NCSS-PASS, NCSS, Kaysville, UT). The patient will be considered as a statistical unit; however an additional analysis based on the specific dental site will also be performed.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Gracey micro-curettes; Subgingival mechanical debridement will be performed using an ultrasonic scaler with specific thin tips and Gracey micro-curette.	Procedure: Gracey micro-curettes; 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.
Active Comparator: Standard Gracey curettes; Subgingival mechanical debridement will be performed using a conventional ultrasonic scaler and standard Gracey curettes.	Procedure: Standard Gracey curettes; After local anaesthesia, non surgical subgingival debridement will be performed by standard Gracey curettes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Full-Mouth Plaque Score (FMPS) (percentage)	Percentage of tooth sites revealing the presence of plaque	baseline, 1 week after supragingival scaling, 6 months after non-surgical periodontal therapy
Change of Full-Mouth Bleeding Score (FMBS) (percentage)	Percentage of tooth sites revealing the presence of bleeding on probing	baseline, 1 week after supragingival scaling, 6 months after non-surgical periodontal therapy
Change of Clinical Attachment Level (CAL) (millimeters)	Distance from the cement-enamel junction to the bottom of the pocket and gingival recession	baseline, 1 week after supragingival scaling, 6 months after non-surgical periodontal therapy
Change of Gingival Recession (GR) (millimeters)	Distance from gingival margin to the cement-enamel junction	baseline, 1 week after supragingival scaling, 6 months after non-surgical periodontal therapy

Collaborators and Investigators

• Sponsor: Federico II University

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: September 6, 2021
• First Submitted That Met QC Criteria: September 28, 2021
• First Posted (Actual): September 29, 2021

Study Record Updates

• Last Update Posted (Estimated): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Periodontitis; Periodontal therapy; Osseous defects
• Additional Relevant MeSH Terms: Pathologic Processes; Stomatognathic Diseases; Mouth Diseases; Inflammation; Periodontal Diseases
• Other Study ID Numbers: 465/20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No