RecruitingNot Applicable

Flapless Periodontal Regeneration Using Hyaluronic Acid Versus Enamel Matrix Derivative

Spain60 participantsStarted 2024-10-26

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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 th…

What they're measuring

Radiographic bone fill

Timeframe: Baseline, 6 and 12 months.

Trial details

NCT IDNCT07339605

SponsorUniversity of Valencia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-07

Contact for this trial

Ferran Sánchez Benito

+34646411370 sanbefe@alumni.uv.es