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Minimally Non Surgical Periodontal Therapy Compared to Traditional Approach

Primary Purpose

Periodontal Diseases, Periodontal Inflammation

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Gracey micro-curettes
Standard Gracey curettes
Sponsored by
Federico II University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontal Diseases focused on measuring Periodontitis, Osseous defects, Periodontal therapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Gracey micro-curettes

    Standard Gracey curettes

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Change of Probing Depth (PD) (millimeters)
    The distance from gingival margin to the bottom of the pocket

    Secondary Outcome Measures

    Change of Full-Mouth Plaque Score (FMPS) (percentage)
    Percentage of tooth sites revealing the presence of plaque
    Change of Full-Mouth Bleeding Score (FMBS) (percentage)
    Percentage of tooth sites revealing the presence of bleeding on probing
    Change of Clinical Attachment Level (CAL) (millimeters)
    Distance from the cement-enamel junction to the bottom of the pocket and gingival recession
    Change of Gingival Recession (GR) (millimeters)
    Distance from gingival margin to the cement-enamel junction

    Full Information

    First Posted
    September 6, 2021
    Last Updated
    February 14, 2023
    Sponsor
    Federico II University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05060601
    Brief Title
    Minimally Non Surgical Periodontal Therapy Compared to Traditional Approach
    Official Title
    Healing of Periodontal Pockets Following Treatment With Minimally Non Surgical Approach or Conventional Non Surgical Therapy. A Randomized Controlled Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2023 (Anticipated)
    Primary Completion Date
    January 1, 2024 (Anticipated)
    Study Completion Date
    March 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Federico II University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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).
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Periodontal Diseases, Periodontal Inflammation
    Keywords
    Periodontitis, Osseous defects, Periodontal therapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Gracey micro-curettes
    Arm Type
    Experimental
    Arm Description
    Subgingival mechanical debridement will be performed using an ultrasonic scaler with specific thin tips and Gracey micro-curette.
    Arm Title
    Standard Gracey curettes
    Arm Type
    Active Comparator
    Arm Description
    Subgingival mechanical debridement will be performed using a conventional ultrasonic scaler and standard Gracey curettes.
    Intervention Type
    Procedure
    Intervention Name(s)
    Gracey micro-curettes
    Intervention Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Standard Gracey curettes
    Intervention Description
    After local anaesthesia, non surgical subgingival debridement will be performed by standard Gracey curettes
    Primary Outcome Measure Information:
    Title
    Change of Probing Depth (PD) (millimeters)
    Description
    The distance from gingival margin to the bottom of the pocket
    Time Frame
    baseline, 1 week after supragingival scaling, 6 months after non-surgical periodontal therapy
    Secondary Outcome Measure Information:
    Title
    Change of Full-Mouth Plaque Score (FMPS) (percentage)
    Description
    Percentage of tooth sites revealing the presence of plaque
    Time Frame
    baseline, 1 week after supragingival scaling, 6 months after non-surgical periodontal therapy
    Title
    Change of Full-Mouth Bleeding Score (FMBS) (percentage)
    Description
    Percentage of tooth sites revealing the presence of bleeding on probing
    Time Frame
    baseline, 1 week after supragingival scaling, 6 months after non-surgical periodontal therapy
    Title
    Change of Clinical Attachment Level (CAL) (millimeters)
    Description
    Distance from the cement-enamel junction to the bottom of the pocket and gingival recession
    Time Frame
    baseline, 1 week after supragingival scaling, 6 months after non-surgical periodontal therapy
    Title
    Change of Gingival Recession (GR) (millimeters)
    Description
    Distance from gingival margin to the cement-enamel junction
    Time Frame
    baseline, 1 week after supragingival scaling, 6 months after non-surgical periodontal therapy

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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