Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 12:46 PM
Study NCT ID:
NCT07421934
Status:
TERMINATED
Last Update Posted:
2026-02-19
First Post:
2026-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Performance and Safety of a Linear Hyaluronic Acid-Based Medical Device in the Treatment of Surgical Wounds in the Oral Cavity.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'whyStopped': 'We agreed with the sponsor that the recruitment of 28 subjects would already be sufficient to obtain statistically significant results. For this reason, we submitted an amendment to the Ethics Committee.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2024-10-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-12', 'studyFirstSubmitDate': '2026-02-12', 'studyFirstSubmitQcDate': '2026-02-12', 'lastUpdatePostDateStruct': {'date': '2026-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement in Clinical Healing Score (CHS)', 'timeFrame': '7 days after the surgical treatment (Visit 2).', 'description': 'The Clinical Healing Score is a clinician-reported assessment used to evaluate the quality of wound healing on a scale from 1 to 5.\n\n5 (Excellent): All wound area is pink; no bleeding on palpation; no granulation tissue; no connective tissue at incision margin.\n\n4 (Very Good): Less than one quarter of wound area is red; no bleeding on palpation; no granulation tissue; no connective tissue at incision margin.\n\n3 (Good): Less than half of the wound area is red; no bleeding on palpation; no granulation tissue; no connective tissue at incision margin.\n\n2 (Poor): More than half of the wound area is red; bleeding on palpation; granulation tissue evident; incision margin not epithelialized.\n\n1 (Very Poor): Two or more features present, such as more than half of the wound area being red, bleeding on palpation, evident granulation tissue, no epithelium at incision margin, or infection with suppuration.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Interventional, monocentric, controlled trial', 'Medical Device Class III', 'Linear Hyaluronic Acid (HA)', 'Amino Acid complex (L-proline, L-hydroxyproline, Glycine, L-lysine)', 'Split-mouth design (one treated site vs one internal control site', 'Oral surgery and post-surgical wounds', 'Tooth extraction (impacted third molar)', 'Wound healing acceleration', 'Clinical Healing Score (CHS)', 'Morphometric analysis of oral mucosa', 'Post-extractive alveolar socket treatment', 'High molecular weight sodium hyaluronate (2500-3500 Kd)'], 'conditions': ['Post-surgical Oral Wounds', 'Oral Cavity Surgery', 'Wound Healing/Regeneration', 'Dental Extraction Sites', 'Alveolar Socket Recovery', 'Post-extractive Inflammation']}, 'descriptionModule': {'briefSummary': 'The PR-DENT study is an interventional, single-center, controlled clinical investigation aimed at evaluating the clinical performance and safety of a Class III medical device based on linear hyaluronic acid for the treatment of oral surgical wounds.\n\nThe investigational device consists of high molecular weight sodium hyaluronate (2500-3500 kDa), obtained through bacterial fermentation, combined with amino acids (L-proline, L-hydroxyproline, glycine, and L-lysine HCl), formulated at a concentration of 25 mg/ml. The device is designed to promote wound healing through the hydrating and film-forming properties of hyaluronic acid, creating a favorable microenvironment for re-epithelialization and tissue regeneration.\n\nThe study is sponsored by The Wave Innovation Srl and conducted at the Oral Surgery and Stomatology Unit of the Azienda Ospedaliera Universitaria Luigi Vanvitelli, under the scientific responsibility of Prof. Luigi Laino. No additional costs are foreseen for the National Health Service, and no compensation is provided to investigators.\n\nThe primary objective of the study is to assess the safety and clinical performance of the device in improving the healing of post-surgical oral wounds. The main outcomes include improvement in the Clinical Healing Score (CHS)-a clinical score assessing redness, edema, suppuration, healthy granulation tissue, and signs of re-epithelialization-the rate of wound closure evaluated through morphometric analysis, and the incidence of adverse events.\n\nThe study population consists of adult patients requiring extraction of at least two teeth. For each patient, two surgical sites are identified: one treated with the hyaluronic acid-based device and one serving as an internal control, allowing for direct intra-patient comparison. The device is injected into the post-extraction socket prior to suturing or applied to the adjacent soft tissues.\n\nThe study design includes a screening visit (Visit 0), a surgical treatment visit (Visit 1), and three follow-up visits at 7, 14, and 30 days after treatment completion (Visits 2, 3, and 4). During follow-up visits, the Clinical Healing Score, wound closure via morphometric analysis, and the occurrence of any adverse events are assessed.\n\nInclusion criteria include adult patients in good systemic and oral health, able to comply with study procedures, and who have provided written informed consent. Exclusion criteria include factors that may interfere with wound healing, such as smoking more than 10 cigarettes per day, recent oncological therapies, recent antibiotic therapy, bisphosphonate treatment, pregnancy or breastfeeding, and acute infection at the surgical site.\n\nSafety is evaluated through the recording and classification of all adverse events (AEs) and serious adverse events (SAEs), in accordance with applicable regulations and Good Clinical Practice (ISO 14155). Risks associated with the use of the device are considered minimal and mainly related to the surgical procedure itself. Based on extensive scientific literature supporting the use of hyaluronic acid in oral wound healing, the overall risk-benefit profile is considered favorable.\n\nThe study is conducted in compliance with the principles of the Declaration of Helsinki, Good Clinical Practice, and Regulation (EU) 2017/745 on medical devices.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients requiring extractive surgery in at least two different sites , with a good state of oral and systemic health.\n* Subjects capable of complying with the study protocol procedures.\n* Provision of a signed Informed Consent form.\n\nExclusion Criteria:\n\n* Patients with a history of alcoholism.\n* Smokers of more than 10 cigarettes per day.\n* Patients who have undergone radiotherapy, chemotherapy, or immunosuppressive therapy within the last five years.\n* Patients who have undergone antibiotic therapy within the last two months.\n* Patients on bisphosphonate therapy.\n* Patients with poor oral hygiene, an acute infection at the treatment site, or any contraindications to extractive surgery.\n* Allergies to local anesthetics.\n* Pregnancy and breastfeeding.'}, 'identificationModule': {'nctId': 'NCT07421934', 'acronym': 'PR-DENT', 'briefTitle': 'Evaluation of the Performance and Safety of a Linear Hyaluronic Acid-Based Medical Device in the Treatment of Surgical Wounds in the Oral Cavity.', 'organization': {'class': 'INDUSTRY', 'fullName': 'The Wave Innovation Group s.r.l.'}, 'officialTitle': 'Evaluation of the Performance and Safety of a Linear Hyaluronic Acid-Based Medical Device in the Treatment of Surgical Wounds in the Oral Cavity.', 'orgStudyIdInfo': {'id': 'CIP-01-23'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental: Linear Hyaluronic Acid', 'description': 'Description: Participants in this arm receive a single injection of a Class III medical device composed of high molecular weight linear hyaluronic acid (25 mg/ml) and a specific complex of amino acids (L-proline, L-hydroxyproline, Glycine, L-lysine HCl).\n\nProcedure: The gel is administered directly into the post-extractive alveolar socket or applied to the adjacent soft tissues immediately following the surgical extraction of a dental element and prior to wound suturing.\n\nDosage: The device is supplied in a 2 ml pre-filled sterile syringe.\n\nObjective: The intervention is intended to create a favorable microenvironment for healing, providing a hydrating film that protects the tissue and promotes rapid re-epithelialization and wound closure.', 'interventionNames': ['Procedure: Intervention: Linear Hyaluronic Acid (Gumblast)']}, {'type': 'SHAM_COMPARATOR', 'label': 'Control: Standard Surgical Procedure', 'description': 'Description: This arm consists of the second surgical site (post-extractive alveolar socket) within the same patient that does not receive the study device.\n\nProcedure: The site undergoes the identical standard surgical extraction protocol as the experimental site but is sutured without the injection or application of the hyaluronic acid-based gel.\n\nObjective: To serve as an internal baseline control for assessing the natural healing process and to compare the safety and performance outcomes (Clinical Healing Score and morphometric analysis) against the experimental intervention.', 'interventionNames': ['Procedure: Control: Standard Surgical Procedure']}], 'interventions': [{'name': 'Intervention: Linear Hyaluronic Acid (Gumblast)', 'type': 'PROCEDURE', 'description': 'Combined Ingredients: Unlike many standalone hyaluronic acid (HA) treatments, this intervention uses a specific complex of high molecular weight linear HA (25 mg/ml) combined with a precise pool of four amino acids: L-proline, L-hydroxyproline, Glycine, and L-lysine HCl.\n\nSpecific HA Molecular Weight: The sodium hyaluronate used has a high molecular weight range of 2500-3500 Kd, produced specifically from Streptococcus equi bacteria.\n\nClass III Classification: The device is classified under Class III (EU 2017/745), emphasizing its biological effect and absorption characteristics within the human body.\n\nSpecific Delivery and Surgical Application:\n\nIntra-Operative Timing: The device is not just a topical post-operative gel; it is specifically injected into the surgical wound or applied to the soft tissues before suturing.\n\nVersatile Delivery Tools: The protocol allows for the use of both pointed or blunt needles applied to a 2 ml pre-filled syringe.', 'armGroupLabels': ['Experimental: Linear Hyaluronic Acid']}, {'name': 'Control: Standard Surgical Procedure', 'type': 'PROCEDURE', 'description': 'Intervention Type: Other (Standard Care/Sham).\n\nDescription: This arm consists of the second surgical site (post-extractive alveolar socket) within the same patient that does not receive the study device.\n\nProcedure: The site undergoes the identical standard surgical extraction protocol as the experimental site but is sutured without the injection or application of the hyaluronic acid-based gel.\n\nObjective: To serve as an internal baseline control for assessing the natural healing process and to compare the safety and performance outcomes (Clinical Healing Score and morphometric analysis) against the experimental intervention.', 'armGroupLabels': ['Control: Standard Surgical Procedure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80138', 'city': 'Naples', 'country': 'Italy', 'facility': 'Dipartimento Multidisciplinare di Specialità Medico-Chirurgiche e Odontoiatriche - Via Luigi De Crecchio,6 , 80138 NAPOLI', 'geoPoint': {'lat': 40.85216, 'lon': 14.26811}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Wave Innovation Group s.r.l.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}