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Gingival RecessionNCT03204565

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

A study testing coronally advanced flap and hyaluronic acid in people with Gingival Recession, run by University of Roma La Sapienza.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gingival Recession
What is being tested?
coronally advanced flap and hyaluronic acid
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
No sites listed yet
Study dates
Sep 2015to 24 Apr 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

About this study

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

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

Read the 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.

Being tested
coronally advanced flap, hyaluronic acid
Keywords
gingival recession, clinical trial(s).
Medical subject headings
Gingival Recession

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • coronally advanced flapProcedure or surgery

    coronally advanced flap alone (CAF- control)

  • hyaluronic acidDevice

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

Study groups in NCT03204565
Study groupRoleWhat they receive
CAF + HA (Test)Experimentalcoronally advanced flap with hyaluronic acid
Receives: Procedure: coronally advanced flap; Device: hyaluronic acid
CAF (control)Active comparatorcoronally advanced flap alone
Receives: Procedure: coronally advanced flap

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recession reduction (RecRed)

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

    Measured: baseline and 18 months

Secondary outcomes (6)

  1. 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).

    Measured: 7 days

  2. Complete root coverage (CRC)

    Assessed as percentage of sites with complete root coverage

    Measured: 18 months

  3. Mean root coverage (MRC)

    Assessed as percentage of mean root coverage for each group.

    Measured: 18 months

  4. Probing pocket depth (PPD)

    Changes in PPD between initial and final. Measured in mm

    Measured: baseline and 18 months

  5. Clinical attachment level gain (CAL-Gain)

    Difference between CAL initial and final. Measured in mm

    Measured: baseline and 18 months

  6. Width of keratinized tissue (KT)

    Changes in KT between initial and final. Measured in mm

    Measured: baseline and 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jul 2017
  2. Study startSep 2015
  3. Primary completion3 Apr 2017
  4. Study completion24 Apr 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03204565
Sponsor's protocol ID
#2538/15
Status last verified
Jun 2017
First submitted
25 Jun 2017
Last updated
2 Jul 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 11989392

  • 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.

    PubMed 24641000

  • 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.

    PubMed 17209788

  • 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.

    PubMed 25315018

  • 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.

    PubMed 25624632

  • 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.

    PubMed 21884772

  • 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.

    PubMed 10231509

  • 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.

    PubMed 2855633

Questions about this trial

What is this clinical trial studying?

A study testing coronally advanced flap and hyaluronic acid in people with Gingival Recession, run by University of Roma La Sapienza.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recession reduction (RecRed) (time frame: baseline and 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03204565, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.

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