Ignite Creation Date:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2025-12-27 @ 6:15 AM
Study NCT ID:
NCT04438434
Status:
UNKNOWN
Last Update Posted:
2020-06-18
First Post:
2020-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Hydrogen Peroxide and Hyaluronic Acid (BMG0703) in the Healing of Post-extraction Sites
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006470', 'term': 'Hemorrhage'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006820', 'term': 'Hyaluronic Acid'}], 'ancestors': [{'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'The products will be packaged in such a way that they are not recognizable either by the operator or by the patient. Each package will be assigned a number that in turn will refer to the type of the product. The association between the number and type of the product will be collected by another operator on the basis of the association carried out by a dedicated software. The operator who will deliver the product will be informed about the type only at the end of the treatment.\n\nThe data will be collected in pseudonymised form and inserted into a dedicated database in order to carry out the statistical analysis provided.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 57}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2020-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-06-16', 'studyFirstSubmitDate': '2020-06-16', 'studyFirstSubmitQcDate': '2020-06-16', 'lastUpdatePostDateStruct': {'date': '2020-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Healing Index (Laundry-Turnbull and Howley, modified by Pippi and coll. in 2015)', 'timeFrame': '7 days', 'description': 'For evaluation of healing, the Laundry-Turnbull and Howley index will be used, considering the changes made by Pippi and coll. in 2015. In particular, seven parameters will be evaluated; a value of 1 or 0 will be assigned to each of these parameters; the sum of the values will indicate the degree of healing to be subsequently compared between the different groups.\n\nIn particular, seven parameters will be assessed, to each of which a value of 1 or 0 will be assigned. The sum of the values will indicate the degree of healing to be compared between the different groups.\n\nThese seven parameters are: redness of mucosa, granulation tissue, suppuration, swelling, re-epithelialization, bleeding, pain on palpation.\n\nHigher score means worse outcome.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Impacted Third Molar Tooth', 'Surgical wound healing', 'Bleeding'], 'conditions': ['Impacted Third Molar Tooth', 'Healing Surgical Wounds']}, 'referencesModule': {'references': [{'pmid': '12636218', 'type': 'BACKGROUND', 'citation': 'Rahban SR, Garner WL. Fibroproliferative scars. Clin Plast Surg. 2003 Jan;30(1):77-89. doi: 10.1016/s0094-1298(02)00069-x.'}, {'pmid': '25867983', 'type': 'BACKGROUND', 'citation': 'Araujo MG, Silva CO, Misawa M, Sukekava F. Alveolar socket healing: what can we learn? Periodontol 2000. 2015 Jun;68(1):122-34. doi: 10.1111/prd.12082.'}, {'pmid': '17335366', 'type': 'BACKGROUND', 'citation': 'Cosyn J, Sabzevar MM. Subgingival chlorhexidine varnish administration as an adjunct to same-day full-mouth root planing. II. Microbiological observations. J Periodontol. 2007 Mar;78(3):438-45. doi: 10.1902/jop.2007.060222.'}, {'pmid': '25709411', 'type': 'BACKGROUND', 'citation': "Lee CT, Zhang S, Leung YY, Li SK, Tsang CC, Chu CH. Patients' satisfaction and prevalence of complications on surgical extraction of third molar. Patient Prefer Adherence. 2015 Feb 10;9:257-63. doi: 10.2147/PPA.S76236. eCollection 2015."}, {'pmid': '18088870', 'type': 'BACKGROUND', 'citation': 'Bouloux GF, Steed MB, Perciaccante VJ. Complications of third molar surgery. Oral Maxillofac Surg Clin North Am. 2007 Feb;19(1):117-28, vii. doi: 10.1016/j.coms.2006.11.013.'}, {'pmid': '39012233', 'type': 'DERIVED', 'citation': 'Boccalari E, Khijmatgar S, Occhipinti C, Del Fabbro M, Inchingolo F, Tartaglia GM. Effect of hydrogen peroxide and hyaluronic acid in mouth rinse after third molar extraction: a triple-blind parallel randomized controlled clinical trial. Eur Rev Med Pharmacol Sci. 2024 Jul;28(13):3946-3957. doi: 10.26355/eurrev_202407_36527.'}]}, 'descriptionModule': {'briefSummary': 'A clinical study to evaluate the efficacy and safety of a mouthwash containing Hydrogen Peroxide, Sodium Hyaluronate and Glycine in the healing of post-extraction sites of wisdom teeth by film forming action.', 'detailedDescription': '57 subjects, with an indication for a third molar extraction, will be enrolled in the study. Participants selection will take place at the IRCCS "Ca" Granda Ospedale Maggiore Policlinico of Milan - UOC Surgery Maxillo Facial and Dentistry where the internship activity of the Degree Course in Dentistry and Dental Prosthetics, Dental Hygiene and the School of Specialization in Orthodontics of the University of Milan is held.\n\nSubsequently, subjects will be equally divided and randomly assigned into the test or control groups. Assessment of outcomes will be carried out at a distance of 7 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '50 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Acceptance of informed consent\n* Need to carry out extraction of a third molar in total or partial impaction\n\nExclusion Criteria:\n\n* subjects suffering from HIV\n* subjects suffering from hepatitis\n* serious systemic diseases preventing the use of specific dental therapies\n* acute and/or chronic infectious diseases\n* inability to provide consent'}, 'identificationModule': {'nctId': 'NCT04438434', 'briefTitle': 'Evaluation of Hydrogen Peroxide and Hyaluronic Acid (BMG0703) in the Healing of Post-extraction Sites', 'organization': {'class': 'OTHER', 'fullName': 'University of Milan'}, 'officialTitle': 'Evaluation of a Filming Formulation of Hydrogen Peroxide and Hyaluronic Acid (BMG0703) in Promoting the Healing of Post-extraction Sites, Compared to Placebo and 0.2% Chlorhexidine. A Randomised Controlled Clinical Trial.', 'orgStudyIdInfo': {'id': 'Orto_BMG0703_WIS_June_2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hydrogen Peroxide and Hyaluronic acid mouthwash (BMG0703)', 'description': 'The enrolled subjects will be examined and treated by specialized medical personnel.\n\nThe extraction will be carried out by an experienced operator and will follow the standard guidelines for the extraction of impacted teeth. Once the tooth has been removed, a suture with detached stitches using silk thread 3/0 will be applied.\n\nFrom a pharmacological point of view, the patient will be prescribed antibiotic therapy (Amoxicillin 1g) to be administered twice daily for seven days, analgesic/anti-inflammatory therapy with NSAIDs (e.g. Synflex 550 mg/Brufen 800 mg) are to be used for a maximum of twice daily.\n\nThe treatment to be evaluated involves mouth rinsing with 10 ml of BMG0703 three times daily, after meals and after normal oral hygiene procedures, for one week (date of the follow-up visit).\n\nPatients with allergic reactions or hypersensitivity to the product will be advised to discontinue its use, and seek medical advice.', 'interventionNames': ['Drug: Filming Formulation of Hydrogen Peroxide and Hyaluronic Acid']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Chlorhexidine 0.2% mouthwash', 'description': 'The enrolled subjects will be examined and treated by specialized medical personnel.\n\nThe extraction will be carried out by an experienced operator and will follow the standard guidelines for the extraction of impacted teeth. Once the tooth has been removed, a suture with detached stitches using silk thread 3/0 will be applied.\n\nFrom a pharmacological point of view, the patient will be prescribed antibiotic therapy (Amoxicillin 1g) to be administered twice daily for seven days, analgesic/anti-inflammatory therapy with NSAIDs (e.g. Synflex 550 mg/Brufen 800 mg) are to be used for a maximum of twice daily.\n\nSubjects in this group are to use Chlorhexidine 0.2% mouthwash as an active comparator; 10 ml three times daily, after meals and after normal oral hygiene procedures, for one week (date of the follow-up visit).\n\nPatients with allergic reactions or hypersensitivity to Chlorhexidine will be advised to discontinue its use, and seek medical advice.', 'interventionNames': ['Drug: Chlorhexidine mouthwash']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo product', 'description': 'The enrolled subjects will be examined and treated by specialized medical personnel.\n\nThe extraction will be carried out by an experienced operator and will follow the standard guidelines for the extraction of impacted teeth. Once the tooth has been removed, a suture with detached stitches using silk thread 3/0 will be applied.\n\nFrom a pharmacological point of view, the patient will be prescribed antibiotic therapy (Amoxicillin 1g) to be administered twice daily for seven days, analgesic/anti-inflammatory therapy with NSAIDs (e.g. Synflex 550 mg/Brufen 800 mg) are to be used for a maximum of twice daily.\n\nSubjects in this group are to use a placebo product, and will be instructed to use 10 ml for mouth rinsing three times daily, after meals and after normal oral hygiene procedures, for one week (date of the follow-up visit).\n\nPatients with allergic reactions or hypersensitivity to the product will be advised to discontinue its use, and seek medical advice.', 'interventionNames': ['Other: Placebo product']}], 'interventions': [{'name': 'Filming Formulation of Hydrogen Peroxide and Hyaluronic Acid', 'type': 'DRUG', 'otherNames': ['BMG0703'], 'description': 'The enrolled subjects will be examined and treated by specialized medical personnel.\n\nThe extraction will be carried out by an experienced operator and will follow the standard guidelines for the extraction of impacted teeth. Once the tooth has been removed, a suture with detached stitches using silk thread 3/0 will be applied.\n\nFrom a pharmacological point of view, the patient will be prescribed antibiotic therapy (Amoxicillin 1g) to be administered twice daily for seven days, analgesic/anti-inflammatory therapy with NSAIDs (e.g. Synflex 550 mg/Brufen 800 mg) are to be used for a maximum of twice daily.\n\nThe treatment to be evaluated involves mouth rinsing with 10 ml of BMG0703 three times daily, after meals and after normal oral hygiene procedures, for one week (date of the follow-up visit).\n\nPatients with allergic reactions or hypersensitivity to the product will be advised to discontinue its use, and seek medical advice.', 'armGroupLabels': ['Hydrogen Peroxide and Hyaluronic acid mouthwash (BMG0703)']}, {'name': 'Chlorhexidine mouthwash', 'type': 'DRUG', 'otherNames': ['Chlorhexidine 0.2%'], 'description': 'The enrolled subjects will be examined and treated by specialized medical personnel.\n\nThe extraction will be carried out by an experienced operator and will follow the standard guidelines for the extraction of impacted teeth. Once the tooth has been removed, a suture with detached stitches using silk thread 3/0 will be applied.\n\nFrom a pharmacological point of view, the patient will be prescribed antibiotic therapy (Amoxicillin 1g) to be administered twice daily for seven days, analgesic/anti-inflammatory therapy with NSAIDs (e.g. Synflex 550 mg/Brufen 800 mg) are to be used for a maximum of twice daily.\n\nSubjects in this group are to use Chlorhexidine 0.2% mouthwash as an active comparator; 10 ml three times daily, after meals and after normal oral hygiene procedures, for one week (date of the follow-up visit).\n\nPatients with allergic reactions or hypersensitivity to Chlorhexidine will be advised to discontinue its use, and seek medical advice.', 'armGroupLabels': ['Chlorhexidine 0.2% mouthwash']}, {'name': 'Placebo product', 'type': 'OTHER', 'otherNames': ['Placebo'], 'description': 'The enrolled subjects will be examined and treated by specialized medical personnel.\n\nThe extraction will be carried out by an experienced operator and will follow the standard guidelines for the extraction of impacted teeth. Once the tooth has been removed, a suture with detached stitches using silk thread 3/0 will be applied.\n\nFrom a pharmacological point of view, the patient will be prescribed antibiotic therapy (Amoxicillin 1g) to be administered twice daily for seven days, analgesic/anti-inflammatory therapy with NSAIDs (e.g. Synflex 550 mg/Brufen 800 mg) are to be used for a maximum of twice daily.\n\nSubjects in this group are to use a placebo product, and will be instructed to use 10 ml for mouth rinsing three times daily, after meals and after normal oral hygiene procedures, for one week (date of the follow-up visit).\n\nPatients with allergic reactions or hypersensitivity to the product will be advised to discontinue its use, and seek medical advice.', 'armGroupLabels': ['Placebo product']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20122', 'city': 'Milan', 'state': 'Lombardy', 'country': 'Italy', 'facility': 'UOC Maxillofacial Surgery and Odontology, University of Milan', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'centralContacts': [{'name': 'Chiara Occhipinti, Professor', 'role': 'CONTACT', 'email': 'Chiara.Occhipinti@unimi.it', 'phone': '+393339155689'}], 'overallOfficials': [{'name': 'Giampietro Farronato, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Milan'}, {'name': 'Gianguido Cossellu, Fellow', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Milan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data available upon request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Milan', 'class': 'OTHER'}, 'collaborators': [{'name': 'BMG Pharma', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Chiara Occhipinti', 'investigatorAffiliation': 'University of Milan'}}}}