Comparison of Clinical and Radiographic Parameters in the Application of Cross-linked Hyaluronic Acid 1.8% and Enamel Matrix Derivative in Periodontal Regeneration.

Summary

The aim of this study is to compare the effectiveness in periodontal regeneration of cross-linked hyaluronic acid at 1.8% (Hyadent BG®) with enamel matrix derivative (Emdogain®) in periodontal bone defects evaluating their clinical and radiographic variables.

Conditions

• Chronic Periodontitis
• Periodontal Bone Loss

Interventions

DRUG

Cross-Linked Hyaluronate Gel Prefilled Syringe 30 MG/3ML

Regenerative periodontal therapy + Cross-linked hyaluronic acid 1.8%: * The modified minimal invasive surgical technique, described by Cortellini 2011, will be used to raise the interdental papilla over the bone defect. * Measurement of bone defect with a 0.5mm periodontal probe (PCP-UNC 15, Hu-Friedy Manufacturing, Illinois, USA) to characterize the defect anatomy. * Inflammatory tissue will be debrided and the root carefully planed using Gracey curettes. * The site will be washed with physiologic sterile solution, dried and the root wil be conditioned with 24% Ethylenediamine tetraacetic acid (EDTA) for two minutes, then the defect area will be carefully rinsed with sterile saline to remove any residual EDTA. * Application of Hyadent BG® 1,8% filling the bone defect from the bottom upwards in the test group. * Single internal modified mattress suture (5/0 Vicryl, Ethicon). * Sutures will be removed after two weeks.

DRUG

Enamel Matrix Proteins (Active comparator group)

Regenerative periodontal therapy + Enamel matrix proteins: * The modified minimal invasive surgical technique, described by Cortellini 2011, will be used to raise the interdental papilla over the bone defect. * Measurement of bone defect with a 0.5mm periodontal probe (PCP-UNC 15, Hu-Friedy Manufacturing, Illinois, USA) to characterize the defect anatomy. * Inflammatory tissue will be debrided and the root carefully planed using Gracey curettes. * The site will be washed with physiologic sterile solution, dried and the root wil be conditioned with 24% Ethylenediamine tetraacetic acid (EDTA) for two minutes, then the defect area will be carefully rinsed with sterile saline to remove any residual EDTA. * Application of Emdogain® filling the bone defect from the bottom upwards in the active comparator group. * Single internal modified mattress suture (5/0 Vicryl, Ethicon). * Sutures will be removed after two weeks.

Sponsors & Collaborators

• Regedent AG, Zürich

  collaborator UNKNOWN

• University of Valencia

  lead OTHER

Principal Investigators

• Andrés López Roldán · University of Valencia

• Manuel Rodríguez Aranda · University of Valencia

• Francisco Alpiste Illueca · University of Valencia

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-03-01

Primary Completion

2020-09-30

Completion

2022-12-31