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Adjunctive Use of Hyaluronic Acid in Multiple Coronally Advanced Flap

Primary Purpose

Gingival Recession, Generalized

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Local application of a HA gel for the treatment of MAGRs with mCAF technique and XCM
Treatment of MAGRs with mCAF technique and XCM
Sponsored by
University of Turin, Italy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingival Recession, Generalized

Eligibility Criteria

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

Inclusion Criteria:

  • At least 18 years old and able to sign informed consent
  • At least 2 adjacent teeth with RT1 and/or RT2 gingival recessions without interproximal exposure of the CEJ (interdental gingival recession), at least one with a depth of ≥2mm with indication for root coverage treatment
  • A minimum of 4 adjacent teeth (including the ones to be treated) in the region of interest
  • Available to attend study related procedures (including follow-up visits)

Exclusion Criteria:

  • Systemic diseases/medications which could influence the outcome of the therapy (e.g., uncontrolled diabetes mellitus);
  • Current smokers (self-reported, any type of smoking), users of chewing tobacco, and drug/alcohol abusers;
  • Pregnant or nursing women;
  • History of previous periodontal surgery (mucogingival or other) on the teeth to be included;
  • Furcation involvement in the teeth to be included;
  • Presence of severe tooth malposition, rotation or clinically significant extrusion in the teeth to be treated;
  • Presence of fixed or removable prosthesis in the area to be treated

Sites / Locations

  • University of TurinRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Xenogenic collagen matrix (XCM) + Hyaluronic acid (HA)

Xenogenic collagen matrix (XCM)

Arm Description

Multiple coronally advanced flap technique (mCAF) with the use of a XCM in combination with local application of a HA gel

Multiple coronally advanced flap technique (mCAF) with the use of a XCM

Outcomes

Primary Outcome Measures

Mean Recession Reduction (RecRed)
Mean changes in mm in recession depth between baseline and 1-year

Secondary Outcome Measures

Complete Root Coverage (CRC)
Percentage of sites with complete root coverage after 1-year
Mean Root Coverage (MRC)
Percentage of mean root coverage after 1-year
Keratinised tissue height (KTH) changes
Linear changes in mm from the gingival margin to the mucogingival junction between baseline and 1-year
Post-operative morbidity (pain, swelling, discomfort)
Assessment of patient's pain, swelling and discomfort at 14 days after the procedure using visual analogue scale (VAS) ranging from 0 (no pain, swelling or discomfort) to 10 (maximum pain, swelling or discomfort) with a questionnaire

Full Information

First Posted
May 6, 2022
Last Updated
May 11, 2022
Sponsor
University of Turin, Italy
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1. Study Identification

Unique Protocol Identification Number
NCT05370456
Brief Title
Adjunctive Use of Hyaluronic Acid in Multiple Coronally Advanced Flap
Official Title
The Adjunctive Use of Hyaluronic Acid for the Treatment of Multiple Adjacent Gingival Recessions With Coronally Advanced Flap Plus Xenogeneic Collagen Matrix: a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 3, 2022 (Actual)
Primary Completion Date
September 10, 2024 (Anticipated)
Study Completion Date
September 10, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Turin, Italy

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
The primary aim of this study is to evaluate whether the effect of HA in combination with XCM for the treatment of MAGRs with a multiple coronally advanced flap technique (mCAF) achieves better results than the XCM with mCAF alone in terms of recession reduction (primary outcome) and other secondary root coverage outcomes (e.g. complete root coverage, mean root coverage). Moreover, this study aims to compare secondary clinical variables (e.g. keratinized tissue width (KTW) changes, probing pocket depth (PPD) changes, volumetric gain (VG), etc.), also with a digital approach, the patient-reported outcome measures (PROMs e.g. pain, swelling, bleeding) and lastly the expression of molecular mediators of tissue healing/regeneration. The hypothesis of this study is that at 6 months and 1 year follow-up the mCAF with XCM+HA is superior to the mCAF with only XCM in terms of recessions reduction and secondary clinical variables, including PROMs.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recession, Generalized

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Xenogenic collagen matrix (XCM) + Hyaluronic acid (HA)
Arm Type
Experimental
Arm Description
Multiple coronally advanced flap technique (mCAF) with the use of a XCM in combination with local application of a HA gel
Arm Title
Xenogenic collagen matrix (XCM)
Arm Type
Active Comparator
Arm Description
Multiple coronally advanced flap technique (mCAF) with the use of a XCM
Intervention Type
Device
Intervention Name(s)
Local application of a HA gel for the treatment of MAGRs with mCAF technique and XCM
Intervention Description
After local anaesthesia, mCAF technique with two releasing vertical incisions will be performed. XCM will be adapted on the root surfaces and positioned at the level of the cemento-enamel junction and HA gel will be applied.
Intervention Type
Procedure
Intervention Name(s)
Treatment of MAGRs with mCAF technique and XCM
Intervention Description
After local anaesthesia, mCAF technique with two releasing vertical incisions will be performed. XCM will be adapted on the root surfaces and positioned at the level of the cemento-enamel junction.
Primary Outcome Measure Information:
Title
Mean Recession Reduction (RecRed)
Description
Mean changes in mm in recession depth between baseline and 1-year
Time Frame
6 months; 1 year
Secondary Outcome Measure Information:
Title
Complete Root Coverage (CRC)
Description
Percentage of sites with complete root coverage after 1-year
Time Frame
6 months; 1 year
Title
Mean Root Coverage (MRC)
Description
Percentage of mean root coverage after 1-year
Time Frame
6 months; 1 year
Title
Keratinised tissue height (KTH) changes
Description
Linear changes in mm from the gingival margin to the mucogingival junction between baseline and 1-year
Time Frame
6 months; 1 year
Title
Post-operative morbidity (pain, swelling, discomfort)
Description
Assessment of patient's pain, swelling and discomfort at 14 days after the procedure using visual analogue scale (VAS) ranging from 0 (no pain, swelling or discomfort) to 10 (maximum pain, swelling or discomfort) with a questionnaire
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: At least 18 years old and able to sign informed consent At least 2 adjacent teeth with RT1 and/or RT2 gingival recessions without interproximal exposure of the CEJ (interdental gingival recession), at least one with a depth of ≥2mm with indication for root coverage treatment A minimum of 4 adjacent teeth (including the ones to be treated) in the region of interest Available to attend study related procedures (including follow-up visits) Exclusion Criteria: Systemic diseases/medications which could influence the outcome of the therapy (e.g., uncontrolled diabetes mellitus); Current smokers (self-reported, any type of smoking), users of chewing tobacco, and drug/alcohol abusers; Pregnant or nursing women; History of previous periodontal surgery (mucogingival or other) on the teeth to be included; Furcation involvement in the teeth to be included; Presence of severe tooth malposition, rotation or clinically significant extrusion in the teeth to be treated; Presence of fixed or removable prosthesis in the area to be treated
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mario Aimetti, PA
Phone
00390116331541
Email
mario.aimetti@unito.it
Facility Information:
Facility Name
University of Turin
City
Turin
ZIP/Postal Code
10126
Country
Italy
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Adjunctive Use of Hyaluronic Acid in Multiple Coronally Advanced Flap

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