Actively Recruiting
Flapless Periodontal Regeneration Using Hyaluronic Acid Versus Enamel Matrix Derivative
Led by University of Valencia · Updated on 2026-01-14
60
Participants Needed
1
Research Sites
139 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Flapless Periodontal Regeneration Using Hyaluronic Acid Versus Enamel Matrix Derivative
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Periodontitis stage III or IV, grade A or B with attachment loss 5mm and radiographic bone loss to middle third or beyond
- Tooth loss of 4 or more due to periodontitis
- Probing depth of 6mm or more
- Adults 18 years or older with balanced numbers per sex
- Plaque index less than 1 after initial periodontal therapy and hygiene instructions
- Bleeding on probing 10% or less
- Patients showing optimal compliance during etiological therapy
- At least a 2-3 wall interproximal bone defect with moderate or deep intrabony defect of 3mm or more
- Probing depth of 6mm or more on specific teeth after non-surgical periodontal treatment
- Vital teeth or teeth with well-performed root canal treatment
- No caries, prosthetic restoration, or periapical infection in the tooth to be treated
- No systemic pathology
- Negative history of pregnancy
- Signed informed consent
- Willingness and ability to attend all necessary study visits for treatment and evaluations
You will not qualify if you...
- Pregnant, breastfeeding, or planning pregnancy within 6 months
- Smoking 10 or more cigarettes per day
- Daily alcohol intake exceeding 4 units
- Chronic illness or reduced mental capacity affecting study compliance
- Medications or conditions altering healing or causing oral manifestations affecting safety or efficacy assessment
- Systemic diseases like diabetes mellitus or rheumatoid disease that may influence treatment
- Allergies to study drug compounds
- Antibiotic use within 3 months before study or need for antibiotics during treatment
- Periodontal treatment within 6 months before study enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Clínica Odontológica de la Universidad de Valencia
Valencia, Valencia, Spain, 46010
Actively Recruiting
Research Team
F
Ferran Sánchez Benito
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here