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

NCT03204565 | Completed

• 1 other identifier: #2538/15
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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

Conditions

Gingival Recession

Keywords

gingival recession, clinical trial(s).

Outcome Measures

Primary Outcomes (1)

• Recession reduction (RecRed)

  Changes in recession depth between initial and final. Measured in mm

  baseline and 18 months

Secondary Outcomes (6)

• Post-operative morbidity (pain, swelling and discomfort)

  7 days

• Complete root coverage (CRC)

  18 months

• Mean root coverage (MRC)

  18 months

• Probing pocket depth (PPD)

  baseline and 18 months

• Clinical attachment level gain (CAL-Gain)

  baseline and 18 months

Study Arms (2)

CAF + HA (Test)

EXPERIMENTAL

coronally advanced flap with hyaluronic acid

Procedure: coronally advanced flap; Device: hyaluronic acid

CAF (control)

ACTIVE COMPARATOR

coronally advanced flap alone

Procedure: coronally advanced flap

Interventions

coronally advanced flap PROCEDURE

coronally advanced flap alone (CAF- control)

CAF (control); CAF + HA (Test)

hyaluronic acid DEVICE

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

CAF + HA (Test)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Related Publications (8)

• 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.

  PMID: 11989392 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.

  PMID: 24641000 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.

  PMID: 17209788 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.

  PMID: 25315018 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.

  PMID: 25624632 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.

  PMID: 21884772 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.

  PMID: 10231509 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.

  PMID: 2855633 BACKGROUND

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Study Officials

• Andrea Pilloni, MD,DDS,MS

  University La Sapienza, Rome

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman Section of Periodontics Director of Master Program in Periodontics

Study Record Dates

• First Submitted: June 25, 2017
• First Posted: July 2, 2017
• Study Start: September 1, 2015
• Primary Completion: April 3, 2017
• Study Completion: April 24, 2017
• Last Updated: July 2, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share