Effectiveness of Adjunctive Hyaluronic Acid Application in Coronally Advanced Flap in Single Gingival Recession Sites

Gingival Recession Clinical Trial

Official title:

Effectiveness of Adjunctive Hyaluronic Acid Application in Coronally Advanced Flap in Miller Class I Single Gingival Recession Sites

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03204565
• Other study ID #: #2538/15
• Status: Completed
• Phase: N/A
• First received: June 25, 2017
• Last updated: June 27, 2017
• Start date: September 2015
• Est. completion date: April 24, 2017

Study information

• Verified date: June 2017
• Source: University of Roma La Sapienza
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 24, 2017
• Est. primary completion date: April 3, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gingival Recession

Intervention

Procedure:
• coronally advanced flap
coronally advanced flap alone (CAF- control)

Device:
• hyaluronic acid
hyaluronic acid associated to coronally advanced flap (CAF + HA- test)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

References & Publications (8)

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. Review. — View Citation

Chen WY, Abatangelo G. Functions of hyaluronan in wound repair. Wound Repair Regen. 1999 Mar-Apr;7(2):79-89. Review. — View 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. — View 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. — View Citation

Moseley R, Waddington RJ, Embery G. Hyaluronan and its potential role in periodontal healing. Dent Update. 2002 Apr;29(3):144-8. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recession reduction (RecRed)	Changes in recession depth between initial and final. Measured in mm	baseline and 18 months
Secondary	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
Secondary	Complete root coverage (CRC)	Assessed as percentage of sites with complete root coverage	18 months
Secondary	Mean root coverage (MRC)	Assessed as percentage of mean root coverage for each group.	18 months
Secondary	Probing pocket depth (PPD)	Changes in PPD between initial and final. Measured in mm	baseline and 18 months
Secondary	Clinical attachment level gain (CAL-Gain)	Difference between CAL initial and final. Measured in mm	baseline and 18 months
Secondary	Width of keratinized tissue (KT)	Changes in KT between initial and final. Measured in mm	baseline and 18 months