Flapless Periodontal Regeneration Using Hyaluronic Acid Versus Enamel Matrix Derivative

Recruiting now · Not applicable

Conditions studied: Guided Tissue Regeneration, Periodontal / Methods, Dental Enamel Proteins* / Therapeutic Use, Alveolar Bone Loss* / Therapy, Hyaluronic Acid* / Therapeutic Use, Humans, Intrabony Defect, Flapless

In brief

The goal of this clinical trial is to radiographically assess the effectiveness of minimally invasive non-surgical technique (MINST) combined with local administration of sodium hypochlorite gel (Perisolv®) and 1.6% cross-linked hyaluronic acid (HA, Hyadent BG®) compared to a neutral formulation of EDTA (Prefgel®) and enamel matrix derivative (EMD, Emdogain® FL) in periodontal regeneration. The main questions it aims to answer are: * ¿Does the combination of MINST with the local administration of sodium hypochlorite gel and 1.6% cross-linked hyaluronic acid show a potential for periodontal regeneration similar to evaluating clinical and radiographic variables compared to a neutral formulation of EDTA and enamel matrix derivative? * ¿What is the patient perception and satisfaction with the received treatment? Researchers will compare A (MINST with Perisolv® + Hyadent BG®), B (MINST with PrefGel® + Emdogain® FL) and C(MINST without any bioactive product). The sample will be distributed according to the following treatments: * Experimental group: Scaling and root planing (SRP), MINST with Perisolv® + Hyadent BG®. * Active comparator group: SRP, MINST with PrefGel® + Emdogain® FL. * Control group: SRP, MINST without any bioactive product. Patients will be screened by a first visit in which they will be assigned their periodontal status. If they meet the eligibility criteria, they will be treated according to the EFP clinical guideline for periodontitis treatment: step I and step II.If the periodontal defect persists at the 12-week re-evaluation, patients will be randomised to treatment A, B or C. After the intervention, all participants will be checked weekly for the first 6 weeks to remove accumulated plaque, and every 3 months for 1 year. Periodontal parameters will be re-evaluated 6 and 12 months after periodontal regenerative intervention.

Key facts

Study ID: NCT07339605
Run by: University of Valencia
People needed: 60
Starts: 2024-10-26
Expected to finish: 2027-07-01
Last updated by the study team: 2026-01-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Periodontitis stage III or IV, grade A or B (Tonetti et al., 2017): attachment loss ≥ 5mm, radiographic bone loss extending to to the middle third and beyond, tooth loss ≥4 due to periodontitis, probing depth (PD) ≥ 6mm.
Older adults ≥ 18 years. The number per sex shall be balanced.
Plaque index (PI) < 1 following initial periodontal therapy and hygiene instructions.
Bleeding on probing (BoP) ≤ 10%.
Only patients with optimal compliance, assessed during etiological therapy, will be selected.
At least a 2-3 wall interproximal bone defect with a radiographically moderate or deep intrabony defect (≥3mm), PD≥ 6mm using a Williams probe on uniradicular teeth or mandibular molars without furcation involvement after non-surgical periodontal treatment.
Vital teeth or teeth with well-performed root canal treatment.
Absence of caries, prosthetic restoration or periapical infection in the tooth to be regenerated.
Absence of systemic pathology.
Negative history of pregnancy.
Signed informed consent.
The participant is willing and able to comply with the necessary visits for the treatments and evaluations scheduled during the clinical study.

You may not qualify if…

The participant is pregnant, breastfeeding or plans to become pregnant in the next 6 months.
Smoking ≥10 cigarettes/day.
Daily alcohol intake > 4U.
Chronic illness or reduced mental capacity that may influence compliance with the protocol.
Medications or drugs that alter the patient's healing or with concomitant oral manifestations that, in the opinion of the investigator, could interfere with the assessment of safety or efficacy.
Systemic diseases that may influence treatment such as diabetes mellitus or rheumatoid disease.
Allergies to drug compounds.
Antibiotic intake 3 months prior to the start of the study or systemic condition requiring antibiotic coverage at the time of periodontal treatment.
Periodontal treatment 6 months prior to the start of the study.

Where it is running

Clínica Odontológica de la Universidad de Valencia — Valencia, Valencia, Spain (enrolling)

Full record on ClinicalTrials.gov

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