NCT07339605 Flapless Periodontal Regeneration Using Hyaluronic Acid Versus Enamel Matrix Derivative
| NCT ID | NCT07339605 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Valencia |
| Condition | Guided Tissue Regeneration, Periodontal / Methods |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-10-26 |
| Primary Completion | 2027-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2024-10-26 with a primary completion date of 2027-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Contact & Investigator
Andrés López Roldán
STUDY DIRECTOR
University of Valencia
Frequently Asked Questions
Who can join the NCT07339605 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Guided Tissue Regeneration, Periodontal / Methods. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07339605 currently recruiting?
Yes, NCT07339605 is actively recruiting participants. Contact the research team at sanbefe@alumni.uv.es for enrollment information.
Where is the NCT07339605 trial being conducted?
This trial is being conducted at Valencia, Spain.
Who is sponsoring the NCT07339605 clinical trial?
NCT07339605 is sponsored by University of Valencia. The principal investigator is Andrés López Roldán at University of Valencia. The trial plans to enroll 60 participants.