Effectiveness of Hyaluronic Acid in the Regeneration of Infrabony Defects

NCT04319770 | Completed

• 1 other identifier: Ref. 3816 - Prot. 2705/15
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Intrabony Periodontal Defect

Outcome Measures

Primary Outcomes (1)

• clinical attachment level (CAL)

  Changes in CAL between initial and final. Measured in mm

  baseline, 12, 28 and 24 months

Secondary Outcomes (2)

• probing pocket depth (PPD)

  baseline, 12, 28 and 24 months

• gingival recession (GR)

  baseline, 12, 28 and 24 months

Study Arms (2)

periodontal regenerative surgery + EMD (control)

ACTIVE COMPARATOR

periodontal regenerative surgery with enamel matrix derivative

Device: enamel matrix derivative (EMD)

periodontal regenerative surgery + HA (test)

EXPERIMENTAL

periodontal regenerative surgery with hyaluronic acid

Device: hyaluronic acid (HA)

Interventions

enamel matrix derivative (EMD) DEVICE

periodontal regenerative surgery with enamel matrix derivative (EMD) (control)

periodontal regenerative surgery + EMD (control)

hyaluronic acid (HA) DEVICE

periodontal regenerative surgery with hyaluronic acid (HA) (test)

periodontal regenerative surgery + HA (test)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Related Publications (7)

• 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.

  PMID: 8483087 RESULT

• 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.

  PMID: 19821315 RESULT

• 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.

  PMID: 7782979 RESULT

• 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.

  PMID: 10815597 RESULT

• 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.

  PMID: 26284973 RESULT

• 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.

  PMID: 19537471 RESULT

• 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.

  PMID: 22012469 RESULT

Study Officials

• Andrea Pilloni, MD,DDS,MS

  University of Roma La Sapienza

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman Section of Periodontics Director of Master Program in Periodontics

Study Record Dates

• First Submitted: March 20, 2020
• First Posted: March 24, 2020
• Study Start: September 6, 2016
• Primary Completion: October 21, 2019
• Study Completion: October 21, 2019
• Last Updated: June 4, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share