Clinical trial NCT04319770: Effectiveness of Hyaluronic Acid in the Regeneration of Infrabony Defects
Official title: Effectiveness of Hyaluronic Acid Versus Enamel Matrix Derivatives in the Regeneration of Infrabony Defects. A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intrabony Periodontal Defect
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2020-03-24
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: clinical attachment level (CAL)
timeFrame: baseline, 12, 28 and 24 months
Secondary outcomes:
measure: probing pocket depth (PPD)
timeFrame: baseline, 12, 28 and 24 months
measure: gingival recession (GR)
timeFrame: baseline, 12, 28 and 24 months
Other outcomes:
Locations:
Study officials:
affiliation: University of Roma La Sapienza
name: Andrea Pilloni, MD,DDS,MS
role: STUDY_DIRECTOR
References:
citation: Cortellini P, Pini Prato G, Tonetti MS. Periodontal regeneration of human infrabony defects. I. Clinical measures. J Periodontol. 1993 Apr;64(4):254-60. doi: 10.1902/jop.1993.64.4.254.
citation: Esposito M, Grusovin MG, Papanikolaou N, Coulthard P, Worthington HV. Enamel matrix derivative (Emdogain(R)) for periodontal tissue regeneration in intrabony defects. Cochrane Database Syst Rev. 2009 Oct 7;2009(4):CD003875. doi: 10.1002/14651858.CD003875.pub3.
citation: Cortellini P, Prato GP, Tonetti MS. The modified papilla preservation technique. A new surgical approach for interproximal regenerative procedures. J Periodontol. 1995 Apr;66(4):261-6. doi: 10.1902/jop.1995.66.4.261.
citation: Cortellini P, Prato GP, Tonetti MS. The simplified papilla preservation flap. A novel surgical approach for the management of soft tissues in regenerative procedures. Int J Periodontics Restorative Dent. 1999 Dec;19(6):589-99.
citation: Zhao N, Wang X, Qin L, Guo Z, Li D. Effect of molecular weight and concentration of hyaluronan on cell proliferation and osteogenic differentiation in vitro. Biochem Biophys Res Commun. 2015 Sep 25;465(3):569-74. doi: 10.1016/j.bbrc.2015.08.061. Epub 2015 Aug 15.
citation: Vanden Bogaerde L. Treatment of infrabony periodontal defects with esterified hyaluronic acid: clinical report of 19 consecutive lesions. Int J Periodontics Restorative Dent. 2009 Jun;29(3):315-23.
citation: Fawzy El-Sayed KM, Dahaba MA, Aboul-Ela S, Darhous MS. Local application of hyaluronan gel in conjunction with periodontal surgery: a randomized controlled trial. Clin Oral Investig. 2012 Aug;16(4):1229-36. doi: 10.1007/s00784-011-0630-z. Epub 2011 Oct 20.