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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CAF + HA (Test) | Experimental | coronally advanced flap with hyaluronic acid |
|
| CAF (control) | Active Comparator | coronally advanced flap alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| coronally advanced flap | Procedure | coronally advanced flap alone (CAF- control) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recession reduction (RecRed) | Changes in recession depth between initial and final. Measured in mm | baseline and 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrea Pilloni, MD,DDS,MS | University La Sapienza, Rome | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11989392 | Background | 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. | |
| 24641000 | Background | 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. |
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| ID | Term |
|---|---|
| D005889 | Gingival Recession |
| ID | Term |
|---|---|
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| hyaluronic acid | Device | hyaluronic acid associated to coronally advanced flap (CAF + HA- test) |
|
| Complete root coverage (CRC) |
Assessed as percentage of sites with complete root coverage |
| 18 months |
| Mean root coverage (MRC) | Assessed as percentage of mean root coverage for each group. | 18 months |
| Probing pocket depth (PPD) | Changes in PPD between initial and final. Measured in mm | baseline and 18 months |
| Clinical attachment level gain (CAL-Gain) | Difference between CAL initial and final. Measured in mm | baseline and 18 months |
| Width of keratinized tissue (KT) | Changes in KT between initial and final. Measured in mm | baseline and 18 months |
| 17209788 | Background | 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. |
| 25315018 | Background | 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. |
| 25624632 | Background | 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. |
| 21884772 | Background | 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. |
| 10231509 | Background | 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. |
| 2855633 | Background | 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. |
| D055093 |
| Periodontal Atrophy |