Effectiveness of Adjunctive Hyaluronic Acid Application in Coronally Advanced Flap in Single Gingival Recession Sites
Primary Purpose
Gingival Recession
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
coronally advanced flap
hyaluronic acid
Sponsored by
About this trial
This is an interventional treatment trial for Gingival Recession focused on measuring gingival recession, clinical trial(s).
Eligibility Criteria
Inclusion Criteria:
- age ≥ 18 years
- full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS) < 15% (measured at four sites per tooth)
- presence of at least one buccal recession (depth ≥2 mm) classified as Miller Class I. Only gingival recession sites localized in the anterior area of the maxillary or mandibular arch (central and lateral incisors, canine and first and second premolars) and associated with aesthetic problems and/or dental hypersensitivity were enclosed
- gingival recession with at least 1 mm of keratinized tissue (KT) apical to the recession
- presence of a clearly identifiable cemento-enamel junction (CEJ), 10) no teeth with prosthetic crown or restoration with the cervical edge in the CEJ area
Exclusion Criteria:
- systemic diseases or pregnancy
- smokers
- systemic antibiotic therapy in the last 6 months
- active periodontal disease with a sites (probing pocket depth <4 mm and no bleeding on probing)
- history of mucogingival or periodontal surgery at the experimental site
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
CAF + HA (Test)
CAF (control)
Arm Description
coronally advanced flap with hyaluronic acid
coronally advanced flap alone
Outcomes
Primary Outcome Measures
Recession reduction (RecRed)
Changes in recession depth between initial and final. Measured in mm
Secondary Outcome Measures
Post-operative morbidity (pain, swelling and discomfort)
With an evaluation questionnaire. The interviewer assessed patient's pain, swelling and discomfort at 7 days after procedure using visual analogue scale (VAS) ranging from 0 (no pain/swelling/discomfort) to 10 (maximal pain/swelling/discomfort).
Complete root coverage (CRC)
Assessed as percentage of sites with complete root coverage
Mean root coverage (MRC)
Assessed as percentage of mean root coverage for each group.
Probing pocket depth (PPD)
Changes in PPD between initial and final. Measured in mm
Clinical attachment level gain (CAL-Gain)
Difference between CAL initial and final. Measured in mm
Width of keratinized tissue (KT)
Changes in KT between initial and final. Measured in mm
Full Information
NCT ID
NCT03204565
First Posted
June 25, 2017
Last Updated
June 27, 2017
Sponsor
University of Roma La Sapienza
1. Study Identification
Unique Protocol Identification Number
NCT03204565
Brief Title
Effectiveness of Adjunctive Hyaluronic Acid Application in Coronally Advanced Flap in Single Gingival Recession Sites
Official Title
Effectiveness of Adjunctive Hyaluronic Acid Application in Coronally Advanced Flap in Miller Class I Single Gingival Recession Sites
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
September 2015 (Actual)
Primary Completion Date
April 3, 2017 (Actual)
Study Completion Date
April 24, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Roma La Sapienza
4. Oversight
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this randomized controlled clinical trial (RCT) is to determine the efficacy hyaluronic acid (HA) in combination with the coronally advanced flap (CAF) for the treatment of single gingival recession site.
The hypothesis is that HA will result in improved the clinical outcomes and will reduce the pos-operative morbidity
Detailed Description
Gingival recession is a common clinical finding in patients with high standards of oral hygiene and can be found in more than 90% of patients. Buccal exposure of roots with aesthetic impairments and dentinal hypersensitivity The ultimate goal of root coverage procedures is the complete coverage of the recession defect with an aesthetic appearance comparable to adjacent healthy soft tissues in combination with physiological probing pocket depths.Several surgical techniques have already provided good results and have been shown to attain root coverage at individual recession sites these different methods.To date, connective tissue grafts (CTG) and enamel matrix derivatives (EMD) in conjunction with a coronally advanced flap (CAF) have been shown to provide the highest probability of obtaining complete root coverage (CRC) in Miller class I and II single gingival recession as compared to CAF alone.
Hyaluronic acid (HA) is a major component of the extracellular matrix in almost all tissues. The primary role of HA is to bind water and to permit the transportation of key metabolites and therefore to maintain the structural and homeostatic integrity of these tissues.
In vitro and animal studies have demonstrated that hyaluronic acid have many properties that are essential for tissue regeneration and wound healing.
However, to the best of our knowledge, there have been limited clinical application studies in the field of root coverage procedures performed and still no consistent published data with longer follow-ups on the usage of HA are available.
Therefore, the aim of this randomized controlled clinical trial (RCT) was to evaluate the potential benefit of the adjunctive use of HA in combination with a coronally advanced flap (CAF) and to compare the outcomes with CAF alone, when treating single Miller Class I gingival recessions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recession
Keywords
gingival recession, clinical trial(s).
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CAF + HA (Test)
Arm Type
Experimental
Arm Description
coronally advanced flap with hyaluronic acid
Arm Title
CAF (control)
Arm Type
Active Comparator
Arm Description
coronally advanced flap alone
Intervention Type
Procedure
Intervention Name(s)
coronally advanced flap
Intervention Description
coronally advanced flap alone (CAF- control)
Intervention Type
Device
Intervention Name(s)
hyaluronic acid
Intervention Description
hyaluronic acid associated to coronally advanced flap (CAF + HA- test)
Primary Outcome Measure Information:
Title
Recession reduction (RecRed)
Description
Changes in recession depth between initial and final. Measured in mm
Time Frame
baseline and 18 months
Secondary Outcome Measure Information:
Title
Post-operative morbidity (pain, swelling and discomfort)
Description
With an evaluation questionnaire. The interviewer assessed patient's pain, swelling and discomfort at 7 days after procedure using visual analogue scale (VAS) ranging from 0 (no pain/swelling/discomfort) to 10 (maximal pain/swelling/discomfort).
Time Frame
7 days
Title
Complete root coverage (CRC)
Description
Assessed as percentage of sites with complete root coverage
Time Frame
18 months
Title
Mean root coverage (MRC)
Description
Assessed as percentage of mean root coverage for each group.
Time Frame
18 months
Title
Probing pocket depth (PPD)
Description
Changes in PPD between initial and final. Measured in mm
Time Frame
baseline and 18 months
Title
Clinical attachment level gain (CAL-Gain)
Description
Difference between CAL initial and final. Measured in mm
Time Frame
baseline and 18 months
Title
Width of keratinized tissue (KT)
Description
Changes in KT between initial and final. Measured in mm
Time Frame
baseline and 18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age ≥ 18 years
full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS) < 15% (measured at four sites per tooth)
presence of at least one buccal recession (depth ≥2 mm) classified as Miller Class I. Only gingival recession sites localized in the anterior area of the maxillary or mandibular arch (central and lateral incisors, canine and first and second premolars) and associated with aesthetic problems and/or dental hypersensitivity were enclosed
gingival recession with at least 1 mm of keratinized tissue (KT) apical to the recession
presence of a clearly identifiable cemento-enamel junction (CEJ), 10) no teeth with prosthetic crown or restoration with the cervical edge in the CEJ area
Exclusion Criteria:
systemic diseases or pregnancy
smokers
systemic antibiotic therapy in the last 6 months
active periodontal disease with a sites (probing pocket depth <4 mm and no bleeding on probing)
history of mucogingival or periodontal surgery at the experimental site
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Pilloni, MD,DDS,MS
Organizational Affiliation
University La Sapienza, Rome
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
11989392
Citation
Moseley R, Waddington RJ, Embery G. Hyaluronan and its potential role in periodontal healing. Dent Update. 2002 Apr;29(3):144-8. doi: 10.12968/denu.2002.29.3.144.
Results Reference
background
PubMed Identifier
24641000
Citation
Cairo F, Nieri M, Pagliaro U. Efficacy of periodontal plastic surgery procedures in the treatment of localized facial gingival recessions. A systematic review. J Clin Periodontol. 2014 Apr;41 Suppl 15:S44-62. doi: 10.1111/jcpe.12182.
Results Reference
background
PubMed Identifier
17209788
Citation
Pilloni A, Paolantonio M, Camargo PM. Root coverage with a coronally positioned flap used in combination with enamel matrix derivative: 18-month clinical evaluation. J Periodontol. 2006 Dec;77(12):2031-9. doi: 10.1902/jop.2006.050390.
Results Reference
background
PubMed Identifier
25315018
Citation
Tatakis DN, Chambrone L, Allen EP, Langer B, McGuire MK, Richardson CR, Zabalegui I, Zadeh HH. Periodontal soft tissue root coverage procedures: a consensus report from the AAP Regeneration Workshop. J Periodontol. 2015 Feb;86(2 Suppl):S52-5. doi: 10.1902/jop.2015.140376. Epub 2014 Oct 15.
Results Reference
background
PubMed Identifier
25624632
Citation
Kumar R, Srinivas M, Pai J, Suragimath G, Prasad K, Polepalle T. Efficacy of hyaluronic acid (hyaluronan) in root coverage procedures as an adjunct to coronally advanced flap in Millers Class I recession: A clinical study. J Indian Soc Periodontol. 2014 Nov-Dec;18(6):746-50. doi: 10.4103/0972-124X.147411.
Results Reference
background
PubMed Identifier
21884772
Citation
Ferguson EL, Roberts JL, Moseley R, Griffiths PC, Thomas DW. Evaluation of the physical and biological properties of hyaluronan and hyaluronan fragments. Int J Pharm. 2011 Nov 25;420(1):84-92. doi: 10.1016/j.ijpharm.2011.08.031. Epub 2011 Aug 22.
Results Reference
background
PubMed Identifier
10231509
Citation
Chen WY, Abatangelo G. Functions of hyaluronan in wound repair. Wound Repair Regen. 1999 Mar-Apr;7(2):79-89. doi: 10.1046/j.1524-475x.1999.00079.x.
Results Reference
background
PubMed Identifier
2855633
Citation
Weigel PH, Frost SJ, McGary CT, LeBoeuf RD. The role of hyaluronic acid in inflammation and wound healing. Int J Tissue React. 1988;10(6):355-65.
Results Reference
background
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Effectiveness of Adjunctive Hyaluronic Acid Application in Coronally Advanced Flap in Single Gingival Recession Sites
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