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Application of Hyaluronic Acid in the Treatment of Periodontitis

Primary Purpose

Periodontal Bone Loss

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Hyaluronic acid
No-hyaluronic acid
Sponsored by
Federico II University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontal Bone Loss focused on measuring Hyaluronic Acid, Suprabony Defect, Surgical Periodontal Therapy, Periodontal Bone Loss

Eligibility Criteria

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

Inclusion Criteria:

  • Patients diagnosed with periodontitis
  • Age ≥ 18 years old
  • Single-rooted and multi-rooted teeth
  • Presence of suprabony periodontal defects at a minimum of two adjacent teeth and a maximum of 7 adjacent teeth in either the maxilla or the mandible with a PD ≥ 5 mm after completion of non-surgical periodontal treatment and re-evaluation
  • Intrabony defect with an intraosseous component < 2 mm

Exclusion Criteria:

  • Patients with systemic diseases
  • Prolonged antibiotic or anti-inflammatory treatment within 4 weeks prior to surgery
  • Pregnant or lactating
  • Tobacco smokers (≥ 10 cigarettes per day)
  • Multi-rooted teeth with furcation involvement
  • Increased tooth mobility (grade II and III)

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 to exposed dental roots surfaces, after scaling and root planing therapy

Only scaling and root planning will be performed on the exposed dental roots surfaces

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

Full Information

First Posted
September 6, 2021
Last Updated
June 22, 2023
Sponsor
Federico II University
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1. Study Identification

Unique Protocol Identification Number
NCT05073575
Brief Title
Application of Hyaluronic Acid in the Treatment of Periodontitis
Official Title
Healing of Periodontal Suprabony Defects Following Treatment With Open Flap Debridement With or Without Hyaluronic Acid (HA) Application
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
October 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 evaluated the healing of suprabony defects following surgical flap elevation and hyaluronic acid application respect to surgical flap elevation alone. A total of 80 patients will be enrolled, selected by inclusion and exclusion criteria and randomly divided in two groups: hyaluronic acid group and no-hyaluronic acid group.
Detailed Description
The objective of the study will be compare the healing of suprabony defects following treatment with either open flap debridement (OFD) and application of hyaluronic acid (HA) with OFD alone. Eighty patients with suprabony periodontal defects will be randomly assigned to treatment with open flap debridement and application of hyaluronic acid (HA Group) or open flap debridement alone (No-HA Group). Primary outcome will be Clinical Attachment Level (CAL) gain, while the secondary outcomes will be Probing Depth (PD) and Gingival Recession (GR). After local anesthesia, an access flap will be prepared. Depending on the mesiodistal width of the interproximal space, two different incision techniques will be selected to access the suprabony defect area. The modified papilla preservation technique (MMPT) will be used at sites with an interproximal width > 2 mm, whereas the simplified papilla preservation technique (SPPT) will be applied at sites with an interproximal width ≤ 2 mm. Then, a mucoperiosteal flap will be reflected. Scaling and root planning will be performed combining the use of metal curettes and power-driven instrumentation by means of ultrasonic scaler. Hyaluronic acid will be applied to exposed roots surface only in HA Group followed, for both groups, by a tension-free primary closure of the interdental papillae and of the mucoperiostal flaps by means of 5-0 monofilament (polypropylene) non-resorbable suturing material.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Bone Loss
Keywords
Hyaluronic Acid, Suprabony Defect, Surgical Periodontal Therapy, Periodontal Bone Loss

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 suprabony defects of subjects allocated in HA group will be treated with open flap debridement and application of hyaluronic acid, while the suprabony defects of No-HA Group will be treated with open flap debridement alone. The null hypothesis of no statistically significant differences between the two modalities for the treatment of suprabony 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
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hyaluronic acid Group
Arm Type
Experimental
Arm Description
Hyaluronic acid gel will be applied to exposed dental roots surfaces, after scaling and root planing therapy
Arm Title
No-hyaluronic acid Group
Arm Type
Active Comparator
Arm Description
Only scaling and root planning will be performed on the exposed dental roots surfaces
Intervention Type
Procedure
Intervention Name(s)
Hyaluronic acid
Intervention Description
After local anesthesia, an access flap will be prepared. Scaling and root planning will be performed combining the use of metal curettes and power-driven instrumentation by means of ultrasonic scaler. Hyaluronic acid gel will be applied to exposed roots surface, followed by a tension-free primary closure of the surgery wound by means of 5-0 monofilament (polypropylene) non-resorbable suturing material.
Intervention Type
Procedure
Intervention Name(s)
No-hyaluronic acid
Intervention Description
An access flap will be prepared in order to perform scaling and root planning therapy with the use of metal curettes. After intervention, a tension-free primary closure of the interdental papillae and of the mucoperiosteal flaps by means of 5-0 monofilament (polypropylene) non-resorbable suturing materia will be performed
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, 6 months after surgical 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, 6 months after surgical periodontal therapy
Title
Change of Gingival Recession (GR) (millimeters)
Description
Distance from gingival margin to the cementoenamel junction
Time Frame
baseline, 6 months after 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: Patients diagnosed with periodontitis Age ≥ 18 years old Single-rooted and multi-rooted teeth Presence of suprabony periodontal defects at a minimum of two adjacent teeth and a maximum of 7 adjacent teeth in either the maxilla or the mandible with a PD ≥ 5 mm after completion of non-surgical periodontal treatment and re-evaluation Intrabony defect with an intraosseous component < 2 mm Exclusion Criteria: Patients with systemic diseases Prolonged antibiotic or anti-inflammatory treatment within 4 weeks prior to surgery Pregnant or lactating Tobacco smokers (≥ 10 cigarettes per day) Multi-rooted teeth with furcation involvement Increased tooth mobility (grade II and III)
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

Application of Hyaluronic Acid in the Treatment of Periodontitis

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