💬In plain words
What the trial is, and whether it could suit you
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
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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 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.
💊
What it tests
- Flapless instrumentation of the defect following MINST in conjuction with NaOCl and hyaluronic acid application
- Flapless instrumentation of the defect following MINST, root conditioning with EDTA and EMD application
- Flapless instrumentation of the defect and product application simulation
Clínica Odontológica de la Universidad de Valencia
Valencia, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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