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
|Condition or disease||Intervention/treatment||Phase|
|Intrabony Periodontal Defect||Device: enamel matrix derivative (EMD) Device: hyaluronic acid (HA)||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|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|
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)
- clinical attachment level (CAL) [ Time Frame: baseline, 12, 28 and 24 months ]Changes in CAL between initial and final. Measured in mm
- probing pocket depth (PPD) [ Time Frame: baseline, 12, 28 and 24 months ]Changes in PPD between initial and final. Measured in mm
- gingival recession (GR) [ Time Frame: baseline, 12, 28 and 24 months ]Changes in GR between initial and final. Measured in mm
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04319770
|Study Director:||Andrea Pilloni, MD,DDS,MS||Sapienza University of Rome|