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

June 27, 2017 updated by: Andrea Pilloni MD DDS MS, University of Roma La Sapienza

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CAF + HA (Test)
coronally advanced flap with hyaluronic acid
Procedure: coronally advanced flap
coronally advanced flap alone (CAF- control)
Device: hyaluronic acid
hyaluronic acid associated to coronally advanced flap (CAF + HA- test)
Active Comparator: CAF (control)
coronally advanced flap alone
Procedure: coronally advanced flap
coronally advanced flap alone (CAF- control)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recession reduction (RecRed)
Time Frame: baseline and 18 months
Changes in recession depth between initial and final. Measured in mm
baseline and 18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
7 days
Complete root coverage (CRC)
Time Frame: 18 months
Assessed as percentage of sites with complete root coverage
18 months
Mean root coverage (MRC)
Time Frame: 18 months
Assessed as percentage of mean root coverage for each group.
18 months
Probing pocket depth (PPD)
Time Frame: baseline and 18 months
Changes in PPD between initial and final. Measured in mm
baseline and 18 months
Clinical attachment level gain (CAL-Gain)
Time Frame: baseline and 18 months
Difference between CAL initial and final. Measured in mm
baseline and 18 months
Width of keratinized tissue (KT)
Time Frame: baseline and 18 months
Changes in KT between initial and final. Measured in mm
baseline and 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Roma La Sapienza

Investigators

  • Study Director: Andrea Pilloni, MD,DDS,MS, University La Sapienza, Rome

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2015

Primary Completion (Actual)

April 3, 2017

Study Completion (Actual)

April 24, 2017

Study Registration Dates

First Submitted

June 25, 2017

First Submitted That Met QC Criteria

June 27, 2017

First Posted (Actual)

July 2, 2017

Study Record Updates

Last Update Posted (Actual)

July 2, 2017

Last Update Submitted That Met QC Criteria

June 27, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • #2538/15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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