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

NCT04274244 | Unknown Phase 4 DMC

• 1 other identifier: UV3
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Periodontitis; Hyaluronic acid; Periodontal regeneration

Outcome Measures

Primary Outcomes (1)

• Clinical measure: Clinical attachment loss (CAL). Changes will be assessed at 3 time points.

  It is defined as the distance in millimeters between CEJ and the end of the periodontal pocket. The calculation of the depth of the pocket + gingival recession or pocket depth - gingival hyperplasia will be carried out.

  1. Baseline, 2. Reevaluation (60 days after root debridement), 3. Second reevaluation (180 days after Periodontal regenerative surgery).

Secondary Outcomes (8)

• Radiographic measure: Cemento-enamel junction (A1)

  1. Baseline, 2. Second reevaluation (180 days after Periodontal regenerative surgery).

• Radiographic measure: B1

  1. Baseline, 2. Second reevaluation (180 days after Periodontal regenerative surgery).

• Radiographic measure: D1

  1. Baseline, 2. Second reevaluation (180 days after Periodontal regenerative surgery).

• Clinical measure: Probing pocket depth (PPD). Changes will be assessed at 3 time points.

  1. Baseline, 2. Reevaluation (60 days after Scale and root planing), 3. Second reevaluation (180 days after Periodontal regenerative surgery).

• Clinical measure: Gingival recession (GR). Changes will be assessed at 3 time points.

  1. Baseline, 2. Reevaluation (60 days after Scale and root planing), 3. Second reevaluation (180 days after Periodontal regenerative surgery).

Study Arms (3)

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

EXPERIMENTAL

1. The study participants will first undergo SCALE AND ROOT PLANING. This procedure is the same as that used in the active comparator group and the control group. 2. Eight weeks following the initial therapy, reevaluation of the intrabony defects in the interproximal sites with a clinical probing depth \>5 mm will be performed by radiographs as well as by using William's graduated periodontal probe to confirm the indication for periodontal surgery. Pairs of premolar and molar teeth in the maxilla or the mandible will be randomized to receive the test treatment (REGENERATIVE PERIODONTAL SURGERY with adjunctive hyaluronic acid gel application) or to serve as active comparators (regenerative periodontal surgery with adjunctive enamel matrix derivative application).

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

Enamel Matrix Proteins

ACTIVE COMPARATOR

1. SCALE AND ROOT PLANING 2. REGENERATIVE PERIODONTAL SURGERY: Application of enamel matrix derivative.

Drug: Enamel Matrix Proteins (Active comparator group)

Scale and root planning

NO INTERVENTION

Control group: Just SCALE AND ROOT PLANING is performed

Interventions

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

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.

Also known as: REGENERATIVE PERIODONTAL SURGERY (Test group)

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

Enamel Matrix Proteins (Active comparator group) DRUG

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.

Also known as: REGENERATIVE PERIODONTAL SURGERY

Enamel Matrix Proteins

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Periodontitis stage II or III, grade A or B: based on the "Consensus report of workgroup of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions" Tonetti 2017. Clinical attachment loss of 3-5mm, radiographic bone loss to the middle third, loss of teeth ≤4 due to periodontitis, probing depth ≥ 6 mm.
• At least, 20 teeth in the mouth.
• Plaque Index (PI) \< 1, following initial nonsurgical periodontal therapy and hygiene instructions.
• At least one interproximal 2, 3-wall bone defect with moderate to deep intrabony defects (≥3mm) on the radiographs, and clinical probing depths (PD) \>5mm using William's graduated periodontal probe on premolars or molars following initial nonsurgical periodontal therapy.
• Absence of caries or overflowing restorations and periapical injuries of the target tooth.
• Non-smokers.
• Absence of systemic disease.
• Negative history for pregnancy
• No relevant medical history that contraindicate periodontal surgery.
• All participants signed an inform consent form.
• The participant is female or male adult of ≥ 18 years. The sample in sex will be compensated.
• The participant is willing and able to return to the treatments and evaluations programmed throughout this clinical study.

You may not qualify if:

• The participant is pregnant or lactating or plans to become pregnant within the next 6 months.
• Heavy smoker (\>10 cigarettes/day).
• The participant takes\> 4 U of alcohol / day.
• The participant has a chronic illness or decreased mental capacity which would mitigate the ability to comply with the protocol.
• Taking drugs that could alter the participant's response in healing or with oral concomitant manifestations that, in the opinion of the investigator, could interfere with the assessment of safety or efficacy.
• Participants with systemic diseases that interfere with treatment such as, Diabetes mellitus, or rheumatoid arthritis.
• Allergies to drug compounds.
• The participant has been treated with antibiotics within 3 months before starting the study or has any other systemic condition that requires antibiotic coverage for routine periodontal procedures (eg, heart disease, prosthetic joints, etc.).
• Participants should not have received periodontal tretment within the 6-month period prior to study.

Sponsors & Collaborators

• University of Valencia: lead
• Regedent AG, Zürich: collaborator

Related Publications (1)

• Rodriguez-A M, Montiel-Company JM, Alpiste-Illueca F, Rodriguez-A L, Paredes-Gallardo V, Lopez-Roldan A. Comparision of crosslinked hyaluronic acid vs. enamel matrix derivative for periodontal regeneration: an 18-month follow-up randomized clinical trial. Clin Oral Investig. 2025 Mar 19;29(4):197. doi: 10.1007/s00784-025-06278-5.

  PMID: 40106008 DERIVED

MeSH Terms

Conditions

Chronic Periodontitis; Alveolar Bone Loss; Periodontitis

Interventions

enamel matrix proteins

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy

Study Officials

• Andrés López Roldán

  University of Valencia

  STUDY DIRECTOR

• Manuel Rodríguez Aranda

  University of Valencia

  PRINCIPAL INVESTIGATOR

• Francisco Alpiste Illueca

  University of Valencia

  STUDY DIRECTOR

Central Study Contacts

Manuel Rodríguez Aranda

CONTACT

+34696902721; m.rodriguezaranda1@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blinding: The researchers who performed the measurements will be different from those who performed the surgery; therefore, the examiner will be blinded during the entire duration of the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: April 9, 2019
• First Posted: February 18, 2020
• Study Start: March 1, 2020
• Primary Completion: September 30, 2020
• Study Completion: December 1, 2022
• Last Updated: February 18, 2020

Record last verified: 2020-02