Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

COMPLETED

NCT04274244

PHASE4

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

Sponsor: University of Valencia

View on ClinicalTrials.gov

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.

Official title: Comparison of Clinical and Radiographic Parameters in the Application of Cross-linked Hyaluronic Acid 1.8% (Hyadent BG®) and Enamel Matrix Derivative (Emdogain®) in Periodontal Regeneration: A Randomized Clinical Trial

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2020-03-01

Completion Date

2024-12-30

Last Updated

2026-07-07

Healthy Volunteers

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.

Inclusion Criteria: 1. 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. 2. At least, 20 teeth in the mouth. 3. Plaque Index (PI) \< 1, following initial nonsurgical periodontal therapy and hygiene instructions. 4. 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. 5. Absence of caries or overflowing restorations and periapical injuries of the target tooth. 6. Non-smokers. 7. Absence of systemic disease. 8. Negative history for pregnancy 9. No relevant medical history that contraindicate periodontal surgery. 10. All participants signed an inform consent form. 11. The participant is female or male adult of ≥ 18 years. The sample in sex will be compensated. 12. The participant is willing and able to return to the treatments and evaluations programmed throughout this clinical study. Exclusion Criteria: 1. The participant is pregnant or lactating or plans to become pregnant within the next 6 months. 2. Heavy smoker (\>10 cigarettes/day). 3. The participant takes\> 4 U of alcohol / day. 4. The participant has a chronic illness or decreased mental capacity which would mitigate the ability to comply with the protocol. 5. 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. 6. Participants with systemic diseases that interfere with treatment such as, Diabetes mellitus, or rheumatoid arthritis. 7. Allergies to drug compounds. 8. 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.). 9. Participants should not have received periodontal tretment within the 6-month period prior to study.

Locations (1)

University of Valencia

Valencia, Valencia, Spain