Periodontal Regeneration With Hyaluronic Acid or Enamel Matrix Derivatives

Minimally Invasive Periodontal Regeneration With a Combination Approach Using Either Hyaluronic Acid or Enamel Matrix Derivatives: a 24-month Multicenter Randomized Controlled Clinical Trial

To date, the quest for ideal biological inductors for periodontal regeneration is still ongoing, especially when facing non-containing defect anatomies. The primary aim of this study is to evaluate the clinical and radiographic performance of a bone graft combined with either enamel matrix derivatives or hyaluronic acid for periodontal regeneration of non-containing intrabony defects in terms of clinical attachment gain (primary outcome) and other secondary outcomes (probing pocket depth reduction, radiographic bone fill). Moreover, this study aims to compare early wound healing and patient-reported outcome measures.

Study Overview

• Status: Recruiting
• Conditions: Periodontitis
• Intervention / Treatment: Device: Hyaluronic acid; Device: Enamel matrix derivatives

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mario Aimetti, PA; Phone Number: 0039 011 6331546; Email: mario.aimetti@unito.it

Study Locations

• Italy
  • Turin, Italy, 10126
    • Recruiting
    • CIR Dental School
    • Contact: Mario Aimetti, Prof.; Phone Number: +39116331541; Email: mario.aimetti@unito.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion criteria:

• Diagnosis of stage III-IV periodontitis.
• Completed steps I-II periodontal therapy.
• FMPS <15% at 3-month re-evaluation.
• FMBS <15% at 3-month re-evaluation.
• At least one site with intrabony defects and residual PPD ≥ 6 mm at re-evaluation, with a radiographic intrabony component ≥ 3 mm, and limited to no extension of the defect on the lingual or palatal side as assessed by preoperative bone sounding.
• Intrasurgically, the defect has to present a non-supporting anatomy (1-2 residual walls in its most coronal portion) and it needs to be accessible by flap elevation only on one side (either buccal or oral).
• Signed informed consent.

Exclusion criteria:

• Compromised general health which contraindicates the study procedures (ASA III-VI patients).
• Systemic diseases/medications which could influence the outcome of the therapy (e.g. uncontrolled diabetes mellitus, non-plaque-induced gingival diseases, antiepileptic drugs (phenytoin and sodium valproate), certain calcium channel-blocking drugs (e.g., nifedipine, verapamil, diltiazem, amlodipine, felodipine), immunoregulating drugs (e.g., ciclosporine), and high-dose oral contraceptives).
• Current smokers (self-reported, ≥ 10 cigarettes a day), users of chewing tobacco, and drug/alcohol abusers.
• Pregnant or nursing women.
• Presence of furcation involvement ≥ II degree (Hamp 1975) at the affected teeth.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hyaluronic acid; Minimally invasive surgical technique with a combined approach using hyaluronic acid gel and a bone xenograft.	Device: Hyaluronic acid; Minimally invasive flap elevation and debridement of the intrabony defect with micro-curettes. Root surface debridement with ultrasonic debridement with periotip and mini-curettes. Application of cross-linked hyaluronic acid gel composed of a mixture of cross-linked (1.6%) and natural (0.2%) hyaluronic acid (hyaDent BG, Regedent, Germany) through a syringe over a bone xenograft (Smartgraft, Regedent, Germany). The mixture will be then compacted within the intrabony component of the defect.
Active Comparator: Enamel matrix derivatives; Minimally invasive surgical technique with a combined approach using enamel matrix derivatives gel and a bone xenograft.	Device: Enamel matrix derivatives; Minimally invasive flap elevation and debridement of the intrabony defect with micro-curettes. Root surface debridement with ultrasonic debridement with periotip and mini-curettes. Enamel matrix derivatives gel (Emdogain, Straumann, Switzerland) will be applied on the dry root surfaces and left in place for at least 1 minute avoiding blood contamination. Subsequently, a bone xenograft (Smartgraft, Regedent, Germany) will be compacted within the intrabony component of the defect.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical attachment level change	Clinical attachment level will be assessed on the experimental teeth using periodontal probe (PCP 15/11.5, Hu-Friedy, Chicago, IL, USA)	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Probing pocket depth change	Probing depth will be assessed on the experimental teeth using periodontal probe (PCP 15/11.5, Hu-Friedy, Chicago, IL, USA)	24 months
Radiographic bone level change	Periapical standardized radiographs will be taken by a clinician masked to the clinical measurements using the paralleling technique and individually customized bite-blocks (RINN XCP Film Holding Instruments, Dentsply, York, USA)	24 months
Patient reported outcome measures	Pain will be self-recorded by the patient using a visual analog scale (from 0 to 10)	14 weeks

Collaborators and Investigators

• Sponsor: University of Turin, Italy

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: October 17, 2023
• First Submitted That Met QC Criteria: October 23, 2023
• First Posted (Actual): October 27, 2023

Study Record Updates

• Last Update Posted (Actual): October 27, 2023
• Last Update Submitted That Met QC Criteria: October 23, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• Other Study ID Numbers: HATurin

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No