[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"flapless\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:flapless":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":33,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":5},"100619052","flapless-periodontal-regeneration-using-hyaluronic-acid-versus-enamel-matrix-derivative-100619052",false,"NCT07339605","Flapless Periodontal Regeneration Using Hyaluronic Acid Versus Enamel Matrix Derivative","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","Inclusion Criteria:\n\n* 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.\n* Older adults ≥ 18 years. The number per sex shall be balanced.\n* Plaque index (PI) \\\u003C 1 following initial periodontal therapy and hygiene instructions.\n* Bleeding on probing (BoP) ≤ 10%.\n* Only patients with optimal compliance, assessed during etiological therapy, will be selected.\n* 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.\n* Vital teeth or teeth with well-performed root canal treatment.\n* Absence of caries, prosthetic restoration or periapical infection in the tooth to be regenerated.\n* Absence of systemic pathology.\n* Negative history of pregnancy.\n* Signed informed consent.\n* The participant is willing and able to comply with the necessary visits for the treatments and evaluations scheduled during the clinical study.\n\nExclusion Criteria:\n\n* The participant is pregnant, breastfeeding or plans to become pregnant in the next 6 months.\n* Smoking ≥10 cigarettes\u002Fday.\n* Daily alcohol intake \\> 4U.\n* Chronic illness or reduced mental capacity that may influence compliance with the protocol.\n* 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.\n* Systemic diseases that may influence treatment such as diabetes mellitus or rheumatoid disease.\n* Allergies to drug compounds.\n* Antibiotic intake 3 months prior to the start of the study or systemic condition requiring antibiotic coverage at the time of periodontal treatment.\n* Periodontal treatment 6 months prior to the start of the study.","ALL","18 Years",{"count":19,"type":20},60,"ESTIMATED","INTERVENTIONAL",[23],"NA","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:\n\n* ¿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?\n* ¿What is the patient perception and satisfaction with the received treatment?\n\nResearchers will compare A (MINST with Perisolv® + Hyadent BG®), B (MINST with PrefGel® + Emdogain® FL) and C(MINST without any bioactive product).\n\nThe sample will be distributed according to the following treatments:\n\n* Experimental group: Scaling and root planing (SRP), MINST with Perisolv® + Hyadent BG®.\n* Active comparator group: SRP, MINST with PrefGel® + Emdogain® FL.\n* Control group: SRP, MINST without any bioactive product.\n\nPatients 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.\n\nAfter 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.",[26,27,28,29,30,31,32],"Guided Tissue Regeneration, Periodontal \u002F Methods","Dental Enamel Proteins* \u002F Therapeutic Use","Alveolar Bone Loss* \u002F Therapy","Hyaluronic Acid* \u002F Therapeutic Use","Humans","Intrabony Defect","Flapless",[34,35,36,37,38],"Periodontitis","Intrabony defect","Hyaluronic acid","Enamel matrix derivative","Periodontal regeneration","RECRUITING","2026-01-04",{"date":42,"type":43},"2026-01-14","ACTUAL",{"date":45,"type":43},"2024-10-26",{"date":47,"type":20},"2027-07",{"name":49,"class":50},"University of Valencia","OTHER"]