Clinical Evaluation of Hyaluronic Acid and Platelet Rich Fibrin Injection Efficacy in Interdental Papilla Reconstruction

2023/218

The goal of this clinical trial is to evaluate and compare the efficacy of injectable platelet rich fibrin (i-PRF) and hyaluronic acid (HA) in reconstruction of interdental papilla loss. The main questions it aims to answer are: * How compareable are above mentioned two interventions (i-PRF\&HA) in reconstruction of interdental papilla loss? * Which treatment option is better accepted by patients? Which treatment option would patients be more satisfied with? Participants with multiple interdental papilla loss will be treated with both i-PRF and HA in split-mouth design. Researchers will compare two treatment options to see if black triangles caused by interdental papilla loss closes and if yes, for how long do they last.

2024-04-10

2024-10-10

2024-11-10

Recruiting

Early phase I

15

Inclusion Criteria: * Systemically healthy (without cardiovascular diseases, diabetes, thyroid diseases, auto-immune diseases) * Patients with PPI 2 and PPI 3 papillae according to the Papillary Presence Index classification * Probable pocket depth of 4 mm or less in the relevant area * Plaque index and gingival index in the range of 0-1 * Neighbouring teeth in contact with each other in the relevant area * Absence of any restoration in the relevant area * Non-smoker * No surgical periodontal treatment in the last 6 months * For female subjects not pregnant or lactating * No known allergy to hyaluronic acid Exclusion Criteria: * Not systemically healthy (with cardiovascular diseases, diabetes, thyroid diseases, auto-immune diseases) * Diagnosed with periodontitis * History of allergic reactions to hyaluronic acid * Less than 2 mm keratinized tissue height in the relevant area * Teeth crowding in relevant area * Any kind of restoration (fillings, crowns, etc.) in the relevant area * Smoker * Ongoing orthodontic treatment * Having parafunctional habits (bruxism, etc.)

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A type of study used frequently in oral research: the mouth is divided into two or more subunits. Active and control (comparison) treatments are applied to the subunits (e.g., to the left and right sides).', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'Participant will be masked which side of her/his mouth treated with either i-PRF or HA.', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 15, 'type': 'ESTIMATED'}}

2024-03-18