Flapless Periodontal Regeneration Using Hyaluronic Acid Versus Enamel Matrix Derivative

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Valencia

About this trial

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

Qualifiers

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%.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • 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

Treatment groups

60 Participants
are divided into 3 treatment groups

Sponsors and collaborators