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
About this trial
This is an interventional treatment trial for Periodontal Diseases focused on measuring Periodontitis, Osseous defects, Periodontal therapy
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
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
NCT ID
NCT05060601
First Posted
September 6, 2021
Last Updated
February 14, 2023
Sponsor
Federico II University
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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Minimally Non Surgical Periodontal Therapy Compared to Traditional Approach
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