Flapless Periodontal Regeneration Using Hyaluronic Acid Versus Enamel Matrix Derivative

University of Valencia

Status: Enrolling

Conditions: Flapless; Dental Enamel Proteins* / Therapeutic Use; Humans; Alveolar Bone Loss* / Therapy; Intrabony Defect; Hyaluronic Acid* / Therapeutic Use; Guided Tissue Regeneration, Periodontal / Methods

Treatments: Procedure: Flapless instrumentation of the defect following MINST, root conditioning with EDTA and EMD application; Procedure: Flapless instrumentation of the defect and product application simulation; Procedure: Flapless instrumentation of the defect following MINST in conjuction with NaOCl and hyaluronic acid application

Study type: Interventional

Funder types: Other

Identifiers

NCT07339605

2023-ODON-3018356

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

60 participants in 3 patient groups

(MINST + NaOCl) + HA

Experimental group

Treatment:

Procedure: Flapless instrumentation of the defect following MINST in conjuction with NaOCl and hyaluronic acid application

(MINST + EDTA) + EMD

Active Comparator group

Treatment:

Procedure: Flapless instrumentation of the defect following MINST, root conditioning with EDTA and EMD application

MINST

Sham Comparator group

Treatment:

Procedure: Flapless instrumentation of the defect and product application simulation