Effectiveness of Hyaluronic Acid in the Regeneration of Infrabony Defects

June 3, 2020 updated by: Andrea Pilloni MD DDS MS, University of Roma La Sapienza

Effectiveness of Hyaluronic Acid Versus Enamel Matrix Derivatives in the Regeneration of Infrabony Defects. A Randomized Controlled Clinical Trial

The purpose of this randomized controlled clinical trial (RCT) is to determine the efficacy hyaluronic acid (HA) versus enamel matrix derivatives (EMD) in the treatment of infrabony periodontal defects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Intrabony defects associated with periodontal pockets represent a risk factor for periodontitis progression and additional loss of attachment if left untreated.

Over the years, several strategies have been implemented for their surgically reconstruction with the aim of pocket reduction and clinical attachment level gain.

Grafting of intrabony periodontal defects has been used extensively over the years incorporating various materials, including autogenic bone, demineralized allogenic bone, xenogenic and alloplastic materials. Controlled clinical studies have shown a significantly higher gain of clinical attachment and radiographic bone gain in intra-bony periodontal defects treated with open flap debridement combined with EMD when compared with open flap debridement alone.

Hyaluronic acid (HAc) is a naturally occurring linear polysaccharide of the extracellular matrix of connective tissue, synovial fluid, and other tissues. It possesses various physiological and structural functions, which include cellular and extracellular interactions, interactions with growth factors and regulation of the osmotic pressure, and tissue lubrication. All these functions help in maintaining the structural and homeostatic integrity of the tissue.

In the field of dentistry, in vitro and animal studies have demonstrated that hyaluronic acid prevents oxygen free-radical damage to granulation tissue, stimulates the clot formation , induces angiogenesis and does not interfere in the calcification nodule during bone formation.

A randomized controlled trial evaluated the effect of local application of 0.8% Hyaluronan gel in conjunction with periodontal surgery. After initial non-surgical periodontal therapy and re-evaluation, defects were randomly assigned to be treated with modified Widman flap surgery in conjunction with either 0.8% Hyaluronan gel (test) or placebo gel (control) application. Statistically, significant differences were noted for Clinical Attachment Level and gingival recession, (P < 0.05) in favor of the test sites. But non-significant results were found regarding PD, BOP and PI values (P > 0.05).

At the present time no comparative data are available about the use of HA versus EMD in treatment of infrabony defects. Therefore the aim of this study will be evaluated the effectiveness of hyaluronic acid versus enamel matrix derivatives alone in the regeneration of infrabony defects.

Study Type

Interventional

Enrollment (Actual)

32

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Patient related:

  • adults aged 18-65 years with periodontal disease
  • sites with infrabony defects and persisting pockets [probing pocket depth (PPD) ≥ 5 mm and bleeding on probing (BOP)] at re-evaluation 6 weeks after non-surgical periodontal therapy
  • full-mouth plaque score (FMPS)1 and full-mouth bleeding score (FMBS)2 < 20% before surgery
  • at least one radiographically detectable infrabony lesion,3
  • good physical health.

Site-specific:

  • Interproximal angular defects on single-rooted teeth
  • radiographic infrabony component ≥ 3 mm
  • PPD ≥ 6 mm and CAL ≥ 7 mm.

Exclusion Criteria:

  • relevant medical conditions contraindicating surgical interventions
  • pregnancy or lactation
  • tobacco smoking
  • untreated periodontal conditions
  • any condition associated with poor compliance or failure to maintain good oral hygiene
  • acute infectious lesions in areas intended for surgery
  • teeth with grade 2 or higher mobility
  • restorations or carious lesions on root surfaces that are associated with the intrabony defect.

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: periodontal regenerative surgery + EMD (control)
periodontal regenerative surgery with enamel matrix derivative
Device: enamel matrix derivative (EMD)
periodontal regenerative surgery with enamel matrix derivative (EMD) (control)
Experimental: periodontal regenerative surgery + HA (test)
periodontal regenerative surgery with hyaluronic acid
Device: hyaluronic acid (HA)
periodontal regenerative surgery with hyaluronic acid (HA) (test)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinical attachment level (CAL)
Time Frame: baseline, 12, 28 and 24 months
Changes in CAL between initial and final. Measured in mm
baseline, 12, 28 and 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
probing pocket depth (PPD)
Time Frame: baseline, 12, 28 and 24 months
Changes in PPD between initial and final. Measured in mm
baseline, 12, 28 and 24 months
gingival recession (GR)
Time Frame: baseline, 12, 28 and 24 months
Changes in GR between initial and final. Measured in mm
baseline, 12, 28 and 24 months

Collaborators and Investigators

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

Sponsor

University of Roma La Sapienza

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 6, 2016

Primary Completion (Actual)

October 21, 2019

Study Completion (Actual)

October 21, 2019

Study Registration Dates

First Submitted

March 20, 2020

First Submitted That Met QC Criteria

March 23, 2020

First Posted (Actual)

March 24, 2020

Study Record Updates

Last Update Posted (Actual)

June 4, 2020

Last Update Submitted That Met QC Criteria

June 3, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ref. 3816 - Prot. 2705/15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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