Ignite Creation Date:
2025-12-24 @ 7:04 PM
Ignite Modification Date:
2026-03-01 @ 9:46 AM
Study NCT ID:
NCT02931357
Status:
COMPLETED
Last Update Posted:
2019-10-02
First Post:
2016-09-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of a New Medical Device in Gel Formulation Versus Calgel® for the Topical Treatment of Teething in Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008012', 'term': 'Lidocaine'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-30', 'studyFirstSubmitDate': '2016-09-29', 'studyFirstSubmitQcDate': '2016-10-10', 'lastUpdatePostDateStruct': {'date': '2019-10-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Teething pain', 'timeFrame': 'day 0, 3 and 7', 'description': 'scored according to intensity with the following Verbal Rating Scale: Absent = 0, Moderate = 1, Intense = 2'}], 'secondaryOutcomes': [{'measure': 'day pain', 'timeFrame': 'day 0, 3 and 7', 'description': 'scored according to intensity with the following Verbal Rating Scale: Absent = 0, Moderate = 1, Intense = 2'}, {'measure': 'gingival rush', 'timeFrame': 'day 0, 3 and 7', 'description': 'scored according to intensity with the following Verbal Rating Scale: Absent = 0, Moderate = 1, Intense = 2'}, {'measure': 'hyper-salivation', 'timeFrame': 'day 0, 3 and 7', 'description': 'scored according to intensity with the following Verbal Rating Scale: Absent = 0, Moderate = 1, Intense = 2'}, {'measure': 'redness', 'timeFrame': 'day 0, 3 and 7', 'description': 'scored according to intensity with the following Verbal Rating Scale: Absent = 0, Moderate = 1, Intense = 2'}, {'measure': 'swelling', 'timeFrame': 'day 0, 3 and 7', 'description': 'scored according to intensity with the following Verbal Rating Scale: Absent = 0, Moderate = 1, Intense = 2'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Treatment of teething in infants'], 'conditions': ['Pain Teeth']}, 'referencesModule': {'references': [{'pmid': '2640634', 'type': 'BACKGROUND', 'citation': "Pytlik W. [Symptoms of the failure of the biological mechanism of teething. Symptomatology of the primary teeth's reinclusion]. Czas Stomatol. 1989 Jan;42(1):29-34. Polish."}, {'pmid': '11924952', 'type': 'BACKGROUND', 'citation': 'McIntyre GT, McIntyre GM. Teething troubles? Br Dent J. 2002 Mar 9;192(5):251-5. doi: 10.1038/sj.bdj.4801349.'}, {'pmid': '20096079', 'type': 'BACKGROUND', 'citation': "Owais AI, Zawaideh F, Al-Batayneh OB. Challenging parents' myths regarding their children's teething. Int J Dent Hyg. 2010 Feb;8(1):28-34. doi: 10.1111/j.1601-5037.2009.00412.x."}, {'pmid': '18280086', 'type': 'BACKGROUND', 'citation': 'Curtis LA, Dolan TS, Seibert HE. Are one or two dangerous? Lidocaine and topical anesthetic exposures in children. J Emerg Med. 2009 Jul;37(1):32-9. doi: 10.1016/j.jemermed.2007.11.005. Epub 2008 Feb 14.'}, {'pmid': '3736072', 'type': 'BACKGROUND', 'citation': 'Weigel PH, Fuller GM, LeBoeuf RD. A model for the role of hyaluronic acid and fibrin in the early events during the inflammatory response and wound healing. J Theor Biol. 1986 Mar 21;119(2):219-34. doi: 10.1016/s0022-5193(86)80076-5.'}, {'pmid': '2967366', 'type': 'BACKGROUND', 'citation': 'Bartold PM. The effect of interleukin-1 beta on hyaluronic acid synthesized by adult human gingival fibroblasts in vitro. J Periodontal Res. 1988 Mar;23(2):139-47. doi: 10.1111/j.1600-0765.1988.tb01347.x. No abstract available.'}, {'pmid': '7529785', 'type': 'BACKGROUND', 'citation': 'Oksala O, Salo T, Tammi R, Hakkinen L, Jalkanen M, Inki P, Larjava H. Expression of proteoglycans and hyaluronan during wound healing. J Histochem Cytochem. 1995 Feb;43(2):125-35. doi: 10.1177/43.2.7529785.'}, {'pmid': '7799210', 'type': 'BACKGROUND', 'citation': 'Irwin CR, Schor SL, Ferguson MW. Effects of cytokines on gingival fibroblasts in vitro are modulated by the extracellular matrix. J Periodontal Res. 1994 Sep;29(5):309-17. doi: 10.1111/j.1600-0765.1994.tb01227.x.'}, {'pmid': '15999421', 'type': 'BACKGROUND', 'citation': 'Pistorius A, Martin M, Willershausen B, Rockmann P. The clinical application of hyaluronic acid in gingivitis therapy. Quintessence Int. 2005 Jul-Aug;36(7-8):531-8.'}, {'pmid': '18488885', 'type': 'BACKGROUND', 'citation': 'Brandt FS, Cazzaniga A. Hyaluronic acid gel fillers in the management of facial aging. Clin Interv Aging. 2008;3(1):153-9. doi: 10.2147/cia.s2135.'}, {'pmid': '17096501', 'type': 'BACKGROUND', 'citation': 'Dagenais S. Intra-articular hyaluronic acid (viscosupplementation) for knee osteoarthritis. Issues Emerg Health Technol. 2006 Nov;(94):1-4.'}, {'pmid': '16979914', 'type': 'BACKGROUND', 'citation': 'Fernandez Lopez JC, Ruano-Ravina A. Efficacy and safety of intraarticular hyaluronic acid in the treatment of hip osteoarthritis: a systematic review. Osteoarthritis Cartilage. 2006 Dec;14(12):1306-11. doi: 10.1016/j.joca.2006.08.003. Epub 2006 Sep 18.'}, {'pmid': '17383810', 'type': 'BACKGROUND', 'citation': 'Iavazzo C, Athanasiou S, Pitsouni E, Falagas ME. Hyaluronic acid: an effective alternative treatment of interstitial cystitis, recurrent urinary tract infections, and hemorrhagic cystitis? Eur Urol. 2007 Jun;51(6):1534-40; discussion 1540-1. doi: 10.1016/j.eururo.2007.03.020. Epub 2007 Mar 20.'}, {'pmid': '9106924', 'type': 'BACKGROUND', 'citation': 'Liguori V, Guillemin C, Pesce GF, Mirimanoff RO, Bernier J. Double-blind, randomized clinical study comparing hyaluronic acid cream to placebo in patients treated with radiotherapy. Radiother Oncol. 1997 Feb;42(2):155-61. doi: 10.1016/s0167-8140(96)01882-8.'}, {'pmid': '22352262', 'type': 'BACKGROUND', 'citation': 'Igic M, Mihailovic D, Kesic L, Apostolovic M, Kostadinovic L, Janjic OT, Milasin J. [Efficacy of hyaluronic acid in the treatment of chronic gingivitis in children]. Vojnosanit Pregl. 2011 Dec;68(12):1021-5. doi: 10.2298/vsp1112021i. Serbian.'}, {'pmid': '12168783', 'type': 'BACKGROUND', 'citation': "Mesa FL, Aneiros J, Cabrera A, Bravo M, Caballero T, Revelles F, del Moral RG, O'Valle F. Antiproliferative effect of topic hyaluronic acid gel. Study in gingival biopsies of patients with periodontal disease. Histol Histopathol. 2002;17(3):747-53. doi: 10.14670/HH-17.747."}, {'pmid': '11989392', 'type': 'BACKGROUND', 'citation': 'Moseley R, Waddington RJ, Embery G. Hyaluronan and its potential role in periodontal healing. Dent Update. 2002 Apr;29(3):144-8. doi: 10.12968/denu.2002.29.3.144.'}, {'pmid': '16918596', 'type': 'BACKGROUND', 'citation': 'Nolan A, Baillie C, Badminton J, Rudralingham M, Seymour RA. The efficacy of topical hyaluronic acid in the management of recurrent aphthous ulceration. J Oral Pathol Med. 2006 Sep;35(8):461-5. doi: 10.1111/j.1600-0714.2006.00433.x.'}, {'pmid': '19267842', 'type': 'BACKGROUND', 'citation': 'Nolan A, Badminton J, Maguire J, Seymour RA. The efficacy of topical hyaluronic acid in the management of oral lichen planus. J Oral Pathol Med. 2009 Mar;38(3):299-303. doi: 10.1111/j.1600-0714.2008.00739.x.'}]}, 'descriptionModule': {'briefSummary': 'This is a randomized, open label, parallel-groups, multicenter study. The study will be conducted in three clinical sites. Test Medical Device: 0.54% Hyaluronic Acid rose honey flavour gel medical device class IIa.', 'detailedDescription': 'Due to the potentially serious toxicity that can result from the use of topical anesthetics to relieving the symptoms associated with gingival inflammatory conditions or gums trauma in infant, recently, products containing Hyaluronic Acid have been marketed in Europe. In particular, Ricerfarma is developing several high molecular weight Hyaluronic Acid medical devices characterized by the absence of preservatives, alcohol and dyes; therefore, the administration of these products in infants is safe and can help creating a natural protective layer on the gingival tissue. In previous clinical trials with these high molecular weight Hyaluronic Acid medical devices it was noted a periodontal tissue/fluid balance with accelerated healing and repair properties that could be of interest either for accelerating the wound healing process or for treating the complex physical symptoms (i.e. soreness and swelling of gums, crying, sleeplessness) related to the teething in infants. These data were confirmed by a recent pilot study on 18 infants suffering by teething where the two formulation of the tested high molecular weight Hyaluronic Acid medical device evidenced, at the end of treatment period, for pain, swelling, gingival rush, hyper-salivation and redness a statistically significant reduction from baseline.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '36 Months', 'minimumAge': '3 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female infants aged between 6 and 36 months.\n2. Teething diagnosed by the presence of at least 3 of the following clinical symptoms:\n\n pain, swelling, gingival rush, hyper-salivation, redness, abnormal teeth depth.\n3. At the moment of inclusion no subcutaneous mucosal laceration must be yet appeared.\n4. Informed consent form signed by parents or legal representative.\n5. Infants and parents who are in a general position to follow all study requirements\n\nExclusion Criteria:\n\n1. Infants in hospitalization and/or immobilization and/or confinement to bed.\n2. Infants with known history of severe renal insufficiency and/or known history of severe cardiac dysfunction and/or liver problems\n3. Use of topical Lidocaine and/or topical Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) within one day before inclusion.\n4. Use of systemic NSAIDs within 3 days before inclusion and/or use of systemic anesthetics within 10 days before.\n5. Concomitant use during the period of study of NSAIDs and/or any anesthetics (obviously Calgel® is allowed in patients randomized in group B, only)\n6. Subjects with known history of allergic or adverse reactions to avian proteins or to HA and to any ingredient of the Medical Device and/or of the comparator on study.\n7. Infants whose parents suffer from any form of psychiatric disorder or other condition which, in the opinion of the Investigator, might invalidate the required prescription and/or observation or complicate communication with the subject.\n8. Infants simultaneously participating or having participated in the last month before Visit 1 in another clinical trial.\n9. Infants already treated under this protocol.'}, 'identificationModule': {'nctId': 'NCT02931357', 'briefTitle': 'Study of a New Medical Device in Gel Formulation Versus Calgel® for the Topical Treatment of Teething in Infants', 'organization': {'class': 'OTHER', 'fullName': 'Ricerfarma S.r.l'}, 'officialTitle': 'A Randomized, Open, Parallel-group Multicenter Study of Efficacy and Tolerability of a New Medical Device in Gel Formulation (Hyaluronic Acid 0.54%) Versus Calgel® for the Topical Treatment of Teething in Infants', 'orgStudyIdInfo': {'id': 'GENG10-12'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hyaluronic Acid 0.54%', 'description': 'Administration: application of the gel on the gingival tissue, massage it in gently, five to six times a day.', 'interventionNames': ['Device: Hyaluronic Acid 0.54%']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Calgel®', 'description': 'Administration: application of the gel on the gingival tissue, massage it in gently, three/four times a day (away from meals). In any case the interval between gel applications must be at least 3 hours.', 'interventionNames': ['Drug: Calgel®']}], 'interventions': [{'name': 'Hyaluronic Acid 0.54%', 'type': 'DEVICE', 'otherNames': ['Hyaluronic Acid gel 0.54%.'], 'description': 'Administration: application of the gel on the gingival tissue, massage it in gently, five to six times a day', 'armGroupLabels': ['Hyaluronic Acid 0.54%']}, {'name': 'Calgel®', 'type': 'DRUG', 'otherNames': ['Lidocaine 0.33% and Cetylpyridinium Chloride 0.10%'], 'description': 'Administration: application of the gel on the gingival tissue, massage it in gently, three/four times a day (away from meals). In any case the interval between gel applications must be at least 3 hours.', 'armGroupLabels': ['Calgel®']}]}, 'contactsLocationsModule': {'locations': [{'zip': '300209', 'city': 'Timișoara', 'state': 'Timiș County', 'country': 'Romania', 'facility': 'Opera Contract Research Organization SRL', 'geoPoint': {'lat': 45.75372, 'lon': 21.22571}}], 'overallOfficials': [{'name': 'Serban Rosu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Societatea Civile Medicala Dr.Rosu'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ricerfarma S.r.l', 'class': 'OTHER'}, 'collaborators': [{'name': 'Opera CRO, a TIGERMED Group Company', 'class': 'OTHER'}, {'name': 'Latis S.r.l.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}