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Completed

NCT Number: NCT03204565

Effectiveness of Adjunctive Hyaluronic Acid Application in Coronally Advanced Flap in 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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

coronally advanced flap

Procedure

coronally advanced flap alone (CAF- control)

Hyaluronic Acid

Device

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

Primary outcomes

  1. Recession reduction (RecRed)

    Time frame: baseline and 18 months

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

Secondary outcomes

  1. Post-operative morbidity (pain, swelling and discomfort)

    Time frame: 7 days

    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).

  2. Complete root coverage (CRC)

    Time frame: 18 months

    Assessed as percentage of sites with complete root coverage

  3. Mean root coverage (MRC)

    Time frame: 18 months

    Assessed as percentage of mean root coverage for each group.

  4. Probing pocket depth (PPD)

    Time frame: baseline and 18 months

    Changes in PPD between initial and final. Measured in mm

  5. Clinical attachment level gain (CAL-Gain)

    Time frame: baseline and 18 months

    Difference between CAL initial and final. Measured in mm

  6. Width of keratinized tissue (KT)

    Time frame: baseline and 18 months

    Changes in KT between initial and final. Measured in mm

Sponsors and collaborators

Lead sponsor

University of Roma La Sapienza

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jul 2, 2017
Registry last updated
Jul 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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