Ignite Creation Date:
2025-12-24 @ 10:32 PM
Ignite Modification Date:
2026-02-23 @ 12:22 PM
Study NCT ID:
NCT05912335
Status:
COMPLETED
Last Update Posted:
2023-06-22
First Post:
2023-05-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Efficiency of Xanthan Hydrogels Containing Local Anesthetics Encapsulated in Nanostructured Lipid Carries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009059', 'term': 'Mouth Diseases'}], 'ancestors': [{'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000779', 'term': 'Anesthetics, Local'}, {'id': 'D004304', 'term': 'Dosage Forms'}], 'ancestors': [{'id': 'D000777', 'term': 'Anesthetics'}, {'id': 'D002492', 'term': 'Central Nervous System Depressants'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D018689', 'term': 'Sensory System Agents'}, {'id': 'D018373', 'term': 'Peripheral Nervous System Agents'}, {'id': 'D002491', 'term': 'Central Nervous System Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D013678', 'term': 'Technology, Pharmaceutical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER'], 'maskingDescription': "The participant and the applicator don't know which formulation was applied because these were named A, B, C, and D and the applicator doesn't have access to the data of which formulation was titled by each letter."}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': '40 volunteers will receive the following formulations: hydrogels containing LAs - lidocaine, and prilocaine (both at 2.5%) encapsulated in CLN (XAN-CLN) or not (XAN-CLN ), EMLA and placebo hydrogel. The formulations will be applied for 2 minutes, bilaterally on the palatal mucosa (first premolar region), in two distinct sessions. Soon after the removal of the topical formulation, an AL will be performed at the region using 0.3 mL of anesthetic solution at an injection speed of 1 mL/min. Pain resulting from needle insertion and LA injection will be measured using two visual analog scales (VAS).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2022-05-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-12', 'studyFirstSubmitDate': '2023-05-25', 'studyFirstSubmitQcDate': '2023-06-12', 'lastUpdatePostDateStruct': {'date': '2023-06-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain sensitivity assessment by Visual Analogue Scale after the puncture of the needle of the local anesthetic.', 'timeFrame': '2 minutes', 'description': 'The blind investigator evaluated the values obtained on VAS, with a rule, the left far end mean 0, for no pain at all and the right far end mean 100 for maximum pain. Therefore, a a higher score means a worse outcome.'}], 'secondaryOutcomes': [{'measure': 'Pain sensitivity assessment by Visual Analogue Scale after the injection of the local anesthetic.', 'timeFrame': '2 minutes', 'description': 'The blind investigator evaluated the values obtained on VAS, with a rule, the left far end mean 0, for no pain at all and the right far end mean 100 for maximum pain. Therefore, a a higher score means a worse outcome.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Topical Anesthesia', 'Topical Formulation', 'Oral Mucosa', 'Lidocaine', 'Prilocaine', 'Nanostructured Lipid Carrier'], 'conditions': ['Dental Trauma', 'Local Anesthesia', 'Oral Cavity Disease']}, 'descriptionModule': {'briefSummary': 'In a crossover, randomized, placebo-controlled, double-blind study, 40 volunteers will receive the following formulations: hydrogels containing LAs (local anesthetic) - lidocaine and prilocaine (both at 2.5%) encapsulated in CLN (XAN-CLN) or not (XAN-CLN ), EMLA (topical anesthetic available on the market) and placebo hydrogel. The formulations will be applied for 2 minutes, bilaterally on the palatal mucosa (first premolar region), in two distinct sessions. Soon after removal of the topical formulation, an AL will be performed at the region using 0.3 mL of anesthetic solution at an injection speed of 1 mL/min. Pain resulting from needle insertion and LA injection will be measured using two visual analog scales (VAS).', 'detailedDescription': 'Dental treatment presents numerous innovations, but the pain associated with the administration of local anesthesia (LA) continuous to be a traumatic procedure for many patients. Although we use topical anesthetics (TA) to reduce pain, the commercially available formulations are only effective in preventing the pain of the needle puncture.\n\nThis project aims to evaluate the clinical efficacy of xanthan-based hydrogels (2%) containing LAs encapsulated in nanostructured lipid carriers (CLN), reducing pain during puncture and injection of LA in the palatine mucosa. In a crossover, randomized, placebo-controlled, double-blind study, 40 volunteers will receive the following formulations: hydrogels containing LAs - lidocaine and prilocaine (both at 2.5%) encapsulated in CLN (XAN-CLN) or not (XAN-CLN ), EMLA and placebo hydrogel. The formulations will be applied for 2 minutes, bilaterally on the palatal mucosa (first premolar region), in two distinct sessions. Soon after the removal of the topical formulation, an AL will be performed at the region using 0.3 mL of anesthetic solution at an injection speed of 1 mL/min. The computerized Morpheus® anesthetic injector will be used in order to control the variables of volume and injection speed. Pain resulting from needle insertion and LA injection will be measured using two visual analog scales (VAS). Hydrogels containing CLN are expected to have good mechanical properties and allow the permeation of LAs efficiently through the oral mucosal epithelium. In addition, they can improve the efficacy of topical anesthesia in order to perform a painless LA in the palatal mucosa.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy participants\n* No lesions in the study area\n* Have already been submitted to local anesthesia without intercurrence\n\nExclusion Criteria:\n\n* Used any drugs that change the pain sensibility 1 week before\n* Smokers\n* Alcoholic'}, 'identificationModule': {'nctId': 'NCT05912335', 'briefTitle': 'Clinical Efficiency of Xanthan Hydrogels Containing Local Anesthetics Encapsulated in Nanostructured Lipid Carries', 'organization': {'class': 'OTHER', 'fullName': 'University of Campinas, Brazil'}, 'officialTitle': 'Clinical Efficiency of Xanthan Hydrogels Containing Local Anesthetics Encapsulated in Nanostructured Lipid Carries', 'orgStudyIdInfo': {'id': 'CAAE: 45317521.9.0000.5418'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Topical anesthetic available on the market - Lidocaine (2.5%), Prilocaine (2.5%)', 'description': 'Applied at palatal mucosa (first premolar region), for 2 minutes. After that, this formulation will be removed.\n\n100 mg.', 'interventionNames': ['Drug: Topical anesthetic']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Xanthan hydrogel 2%', 'description': 'Applied at palatal mucosa (first premolar region), for 2 minutes. After that, this formulation will be removed.\n\n100 mg.', 'interventionNames': ['Drug: Topical anesthetic']}, {'type': 'EXPERIMENTAL', 'label': 'Xanthan hydrogel (2%), Lidocaine (2.5%), Prilocaine (2.5%) in NLC', 'description': 'Applied at palatal mucosa (first premolar region), for 2 minutes. After that, this formulation will be removed.\n\n100 mg. Local Anesthetic encapsulated in nanostructured lipid carriers (NLC)', 'interventionNames': ['Drug: Topical anesthetic']}, {'type': 'EXPERIMENTAL', 'label': 'Xanthan hydrogel (2%), Lidocaine (2.5%), Prilocaine (2.5%)', 'description': 'Applied at palatal mucosa (first premolar region), for 2 minutes. After that, this formulation will be removed.\n\n100 mg.', 'interventionNames': ['Drug: Topical anesthetic']}], 'interventions': [{'name': 'Topical anesthetic', 'type': 'DRUG', 'otherNames': ['Topical Formulation'], 'description': 'The topical anesthetic, or topical formulation, was applied to the palatal mucosa for 2 minutes.', 'armGroupLabels': ['Topical anesthetic available on the market - Lidocaine (2.5%), Prilocaine (2.5%)', 'Xanthan hydrogel (2%), Lidocaine (2.5%), Prilocaine (2.5%)', 'Xanthan hydrogel (2%), Lidocaine (2.5%), Prilocaine (2.5%) in NLC', 'Xanthan hydrogel 2%']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13414903', 'city': 'Piracicaba', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Michelle Franz Montan Braga Leite', 'geoPoint': {'lat': -22.72528, 'lon': -47.64917}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Campinas, Brazil', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Michelle Franz Montan Braga Leite, DDS, MSc, PhD', 'investigatorAffiliation': 'University of Campinas, Brazil'}}}}