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Periodontal Regeneration With Hyaluronic Acid or Enamel Matrix Derivatives

NCT06105112 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-10-27

No results posted yet for this study

Summary

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.

Conditions

  • Periodontitis

Interventions

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.

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.

Sponsors & Collaborators

  • University of Turin, Italy

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-10-01
Primary Completion
2025-10-01
Completion
2026-10-01

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06105112 on ClinicalTrials.gov