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Effectiveness of Hyaluronic Acid in the Regeneration of Infrabony Defects

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ClinicalTrials.gov Identifier: NCT04319770
Recruitment Status : Completed
First Posted : March 24, 2020
Last Update Posted : June 4, 2020
Sponsor:
Information provided by (Responsible Party):
Andrea Pilloni MD DDS MS, University of Roma La Sapienza

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Intrabony Periodontal Defect Device: enamel matrix derivative (EMD) Device: hyaluronic acid (HA) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Hyaluronic Acid Versus Enamel Matrix Derivatives in the Regeneration of Infrabony Defects. A Randomized Controlled Clinical Trial
Actual Study Start Date : September 6, 2016
Actual Primary Completion Date : October 21, 2019
Actual Study Completion Date : October 21, 2019

Resource links provided by the National Library of Medicine


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)




Primary Outcome Measures :
  1. clinical attachment level (CAL) [ Time Frame: baseline, 12, 28 and 24 months ]
    Changes in CAL between initial and final. Measured in mm


Secondary Outcome Measures :
  1. probing pocket depth (PPD) [ Time Frame: baseline, 12, 28 and 24 months ]
    Changes in PPD between initial and final. Measured in mm

  2. gingival recession (GR) [ Time Frame: baseline, 12, 28 and 24 months ]
    Changes in GR between initial and final. Measured in mm



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04319770


Sponsors and Collaborators
University of Roma La Sapienza
Investigators
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Study Director: Andrea Pilloni, MD,DDS,MS Sapienza University of Rome
Publications of Results:

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Responsible Party: Andrea Pilloni MD DDS MS, Chairman Section of Periodontics Director of Master Program in Periodontics, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT04319770    
Other Study ID Numbers: Ref. 3816 - Prot. 2705/15
First Posted: March 24, 2020    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents