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Flapless Periodontal Regeneration Using Hyaluronic Acid Versus Enamel Matrix Derivative
Sponsor: University of Valencia
Summary
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2024-10-26
Completion Date
2027-07
Last Updated
2026-01-14
Healthy Volunteers
No
Conditions
Interventions
Flapless instrumentation of the defect following MINST in conjuction with NaOCl and hyaluronic acid application
The NaOCL gel buffered with amino acids will be carefully injected and maintained for 60 seconds. Following this, pocket debridement will be carried out following the MINST technique. In order to allow for optimal root visualization and gain access to the intrabony defect, a microsurgical dental mirror will be used in conjunction with an atraumatic gingival retractor for a gentle lateral papilla displacement. Teeth will be instrumented until no residual calculus could be detected after a careful root evaluation with a periodontal explorer and no debris or biofilm flushed out of the pocket after irrigation. If this does not occur, the application of NaOCL, instrumentation and saline solution rinse shall be repeated until this is achieved. After irrigation, sterile gauze will be placed in the vestibule in the proximity of a selected site and a thorough drying of the site will be perfomed with air-spray. HA will be applied with a blunt tipped sterile syringe, until overflowing.
Flapless instrumentation of the defect following MINST, root conditioning with EDTA and EMD application
Subgingival instrumentation will be performed following the MINST technique in conjunction with a microsurgical dental mirror and an atraumatic gingival retractor without applying any product previously. Teeth will be instrumented until no residual calculus could be detected and no debris or biofilm flushed out of the pocket after irrigation with sterile saline solution. Following this, it will be dried and the root will be conditioned applying EDTA with a thin blunt tip for 2 minutes to remove the dentin mud layer from the root surfaces. Subsequently, the defect area will be carefully rinsed with water-spray and by 5-s passage of ultrasonic instrument's fine tip in the site with no contact to the root surface. A sterile gauze will be placed in the vestibule in the proximity of a selected site and a thorough drying of the site will be performed with an air-spray. Once bleeding control is achieved, EMD will be applied with a blunt tipped sterile syringe (25G), until overflowing.
Flapless instrumentation of the defect and product application simulation
Subgingival instrumentation will be performed following MINST and EDT+EMD or NaOCl+HA application will be simulated by inserting the manufacturer's syringes within the pocket, but the defects won't receive any adjunct.
Locations (1)
Clínica Odontológica de la Universidad de Valencia
Valencia, Valencia, Spain