Flapless periodontal regeneration with hyaluronic acid versus enamel matrix derivative
Clinical and Radiographic Outcomes After Flapless Approach of Intrabony Defects With the Application of Enamel Matrix Derivative Versus Hyaluronic Acid: A Randomized Controlled Clinical Trial
This will test whether a flapless, minimally invasive treatment using hyaluronic acid helps adults with advanced periodontitis regenerate bone around teeth as well as a treatment using an enamel matrix derivative.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Valencia Academic / other |
| Locations | 1 site (Valencia, Valencia) |
| Trial ID | NCT07339605 on ClinicalTrials.gov |
What this trial studies
This trial compares three flapless approaches after minimally invasive non-surgical therapy: MINST with sodium hypochlorite gel plus cross‑linked hyaluronic acid, MINST with EDTA root conditioning plus enamel matrix derivative, and MINST alone. Participants have moderate-to-deep intrabony periodontal defects and will be followed radiographically to measure bone fill and clinically for pocket depth and healing. Patient perception and satisfaction with the received treatment will also be recorded. The protocol uses standardized flapless instrumentation and local application or simulation of bioactive products to isolate their effects.
Who should consider this trial
Good fit: Adults with stage III or IV periodontitis who have at least one 2–3 wall intrabony defect ≥3 mm with probing depth ≥6 mm, good plaque control and oral hygiene, and no relevant systemic disease are ideal candidates.
Not a fit: Patients with shallow defects, furcation involvement, active local infection, poor oral hygiene or uncontrolled systemic conditions are unlikely to benefit from the interventions tested here.
Why it matters
Potential benefit: If successful, the hyaluronic acid approach could offer a less invasive option that promotes periodontal bone regeneration while improving patient comfort.
How similar studies have performed: Enamel matrix derivative has prior clinical evidence supporting periodontal regeneration, while flapless applications of hyaluronic acid are less well studied but have shown promising early results in smaller reports.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Valencia, Valencia
- Clínica Odontológica de la Universidad de Valencia — Valencia, Valencia, Spain (Recruiting)
Study contacts
- Study coordinator: Ferran Sánchez Benito
- Email: sanbefe@alumni.uv.es
- Phone: +34646411370
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.