Flapless periodontal regeneration with hyaluronic acid versus enamel matrix derivative

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.