Treatment of Intraosseous Periodontal Defects With Hyaluronic Acid
Primary Purpose
Periodontal Bone Loss, Periodontal Pocket
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
MINSD and Hyaluronic acid
MINSD
Sponsored by
About this trial
This is an interventional treatment trial for Periodontal Bone Loss focused on measuring Hyaluronic Acid, Periodontal therapy, Periodontal Bone Loss, Intraosseous Bone Defect
Eligibility Criteria
Inclusion Criteria:
- Patients diagnosed with periodontitis;
- Age ≥ 18 years old;
- Presence of at least 10 teeth per arch;
- Presence of at least two teeth with Probing Depth (PD) ≥ 5 mm per quadrant;
- Presence of at least one intraosseous pocket;
- Single-rooted and multi-rooted teeth.
Exclusion Criteria:
- Patients with systemic diseases;
- Prolonged antibiotic or anti-inflammatory treatment within 4 weeks prior to periodontal therapy;
- Pregnant or lactating;
- Tobacco smokers (≥ 10 cigarettes per day);
- Multi-rooted teeth with furcation involvement;
- Third molars.
Sites / Locations
- University of Naples Federico IIRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Hyaluronic acid Group
No-hyaluronic acid Group
Arm Description
Hyaluronic acid gel will be applied in intraosseous periodontal defects, after Minimally Invasive Non Surgical Debridement (MINSD)
Only Minimally Invasive Non Surgical Debridement (MINSD) will be performed
Outcomes
Primary Outcome Measures
Change of Clinical Attachment Level (CAL) gain (millimeters)
Distance from the cementoenamel junction to the bottom of the pocket
Secondary Outcome Measures
Change of Probing Depth (PD) (millimeters)
Distance from the gingival margin to the bottom of the pocket
Change of Gingival Recession (GR) (millimeters)
Distance from gingival margin to the cementoenamel junction
Change of Radiographic Defect Angle (RDA) (grade °)
Radiographic intraosseous angle
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05188898
Brief Title
Treatment of Intraosseous Periodontal Defects With Hyaluronic Acid
Official Title
Treatment of Intraosseous Periodontal Pockets by Non-surgical Therapy With Micro-instruments and Application of Hyaluronic Acid. A Randomized-controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (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
Yes
5. Study Description
Brief Summary
The aim of the present investigation will be evaluate the healing of periodontal intraosseous defects following Minimally Invasive Non Surgical Debridement (MINSD) and application of a hyaluronic acid-based gel, compared to MINSD alone.
A total of 22 patients will be enrolled, selected by inclusion and exclusion criteria and randomly divided in two groups: hyaluronic acid group (HA) and no-hyaluronic acid group (No-HA).
Detailed Description
The objective of the study will be compare the healing of periodontal intraosseous defects following treatment with Minimally Invasive Non Surgical Debridement (MINSD) and application of hyaluronic acid (HA) compared to MINSD alone.
Twenty-two patients with intraosseous periodontal defects will be randomly assigned to treatment with MINSD and application of a hyaluronic acid-based gel (HA Group) or MINSD alone (No-HA Group).
Primary outcome will be "Clinical Attachment Level" (CAL) gain, while the secondary outcomes will be "Probing Depth" (PD), "Gingival Recession" (GR) and "Radiographic Defect Angle" (RDA).
After local anesthesia, in HA group MINSD will be performed using an ultrasonic scaler with fine tips and micro-curette; then, a hyaluronic acid-based gel will be applied to the intraosseous periodontal pockets.
In the No-HA group, only subgingival mechanical debridement (MINSD) will be performed with an ultrasonic scaler with fine tips and micro-curette.
Finally, a polishing paste will be applied to the supra-gingival level in both groups using a rubber cup. Patients of both groups will be recalled every month for professional oral hygiene and, after 6 months, all measurements will be repeated and the final evaluation will be carried out.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Bone Loss, Periodontal Pocket
Keywords
Hyaluronic Acid, Periodontal therapy, Periodontal Bone Loss, Intraosseous Bone Defect
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study will be designed as a double-arm randomized controlled clinical trial. The intraosseous defects of subjects allocated in HA group will be treated with MINSD and application of hyaluronic acid, while in No-HA Group only MINSD will be performed. The null hypothesis of no statistically significant differences between the two modalities for the treatment of intraosseous defects will be tested.
Masking
Participant
Masking Description
Only patients will be unaware of the type of treatment performed, with prior written informed consent. So, they will be divided in the two groups of study after a process of randomization
Allocation
Randomized
Enrollment
22 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hyaluronic acid Group
Arm Type
Experimental
Arm Description
Hyaluronic acid gel will be applied in intraosseous periodontal defects, after Minimally Invasive Non Surgical Debridement (MINSD)
Arm Title
No-hyaluronic acid Group
Arm Type
Active Comparator
Arm Description
Only Minimally Invasive Non Surgical Debridement (MINSD) will be performed
Intervention Type
Other
Intervention Name(s)
MINSD and Hyaluronic acid
Intervention Description
After local anesthesia, MINSD will be performed using an ultrasonic scaler with fine tips and micro-curette; then, a hyaluronic acid-based gel will be applied to the intraosseous periodontal pockets.
Intervention Type
Other
Intervention Name(s)
MINSD
Intervention Description
Only subgingival mechanical debridement (MINSD) will be performed with an ultrasonic scaler with fine tips and micro-curette.
Primary Outcome Measure Information:
Title
Change of Clinical Attachment Level (CAL) gain (millimeters)
Description
Distance from the cementoenamel junction to the bottom of the pocket
Time Frame
baseline and 6 months after periodontal therapy
Secondary Outcome Measure Information:
Title
Change of Probing Depth (PD) (millimeters)
Description
Distance from the gingival margin to the bottom of the pocket
Time Frame
baseline and 6 months after periodontal therapy
Title
Change of Gingival Recession (GR) (millimeters)
Description
Distance from gingival margin to the cementoenamel junction
Time Frame
baseline and 6 months after periodontal therapy
Title
Change of Radiographic Defect Angle (RDA) (grade °)
Description
Radiographic intraosseous angle
Time Frame
baseline and 6 months after 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:
Patients diagnosed with periodontitis;
Age ≥ 18 years old;
Presence of at least 10 teeth per arch;
Presence of at least two teeth with Probing Depth (PD) ≥ 5 mm per quadrant;
Presence of at least one intraosseous pocket;
Single-rooted and multi-rooted teeth.
Exclusion Criteria:
Patients with systemic diseases;
Prolonged antibiotic or anti-inflammatory treatment within 4 weeks prior to periodontal therapy;
Pregnant or lactating;
Tobacco smokers (≥ 10 cigarettes per day);
Multi-rooted teeth with furcation involvement;
Third molars.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Luca Ramaglia
Phone
+393476912911
Email
luca.ramaglia@unina.it
Facility Information:
Facility Name
University of Naples Federico II
City
Naples
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luca Ramaglia
Phone
+393476912911
Email
luca.ramaglia@unina.it
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Treatment of Intraosseous Periodontal Defects With Hyaluronic Acid
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