Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2025-12-30 @ 8:31 AM
Study NCT ID:
NCT04732104
Status:
COMPLETED
Last Update Posted:
2021-02-01
First Post:
2021-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Lidocaine and Xylometazoline Intranasal Spray in Anesthetizing Maxillary Teeth
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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-03-20', 'size': 526028, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2021-01-21T02:37', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2020-08-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-26', 'studyFirstSubmitDate': '2021-01-14', 'studyFirstSubmitQcDate': '2021-01-26', 'lastUpdatePostDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Achievement of local anesthesia', 'timeFrame': 'First reading on VAS will be taken after administering 2 intranasal sprays i.e. 14 minutes after administration of the first spray', 'description': "local anesthesia will be assessed with the help of Visual Analog Scale. VAS score must be '0' before cavity preparation must begin"}, {'measure': 'Achievement of local anesthesia', 'timeFrame': 'If needed, second reading on VAS will be taken after administering 3 intranasal sprays i.e. 24 minutes after administration of the first spray', 'description': "local anesthesia will be assessed with the help of Visual Analog Scale. VAS score must be '0' before cavity preparation must begin"}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Effect of Drug']}, 'descriptionModule': {'briefSummary': "Different anesthetic techniques are used for achieving pulpal anesthesia of maxillary teeth. Recently tetracaine and oxymetazoline were used as local anesthetic agents in the form of an intranasal spray to achieve pulpal anesthesia of maxillary teeth. However tetracaine has its share of demerits, therefore we in our study have used lidocaine with xylometazoline in the form of an intranasal spray to achieve local anesthesia of maxillary anterior and premolar teeth for restorative procedures.\n\nThe objective of the study was to evaluate the efficacy of 4% lidocaine and 0.1% xylometazoline intranasal spray solution as compared to injectable 2% lidocaine with 1:100,000 epinephrine solution in anesthetizing maxillary anterior \\& premolar teeth for dental restorative procedures.\n\nMETHODS:\n\nA total of 60 patients were enrolled in the study. Consecutive sampling was done for the study participants who met the inclusion criteria. 30 patients were randomized each to lidocaine/Xylometazoline or control local anesthesia group. Group A participants received 4% Lidocaine and 0.1% Xylometazoline solution as intranasal spray while Group B participants received injectable local anesthesia. Group 'A' participants received two doses of intranasal spray anesthesia four minutes apart. Local anesthesia was then assessed by probing soft tissues adjacent to the tooth and reading was taken on the Visual Analog Scale. If the reading was '0' the cavity preparation was performed. If the VAS reading was more than '0' a third dose of intranasal spray anesthesia was delivered. Local anesthesia was again assessed after ten minutes. If profound local anesthesia was still not achieved the case was labeled as failure of intranasal spray anesthesia and local anesthesia was achieved by conventional infiltration anesthesia. For Group B participants, local anesthesia was achieved by means of conventional infiltration anesthesia. Data were recorded on a designed proforma.\n\nChi-square test and Fischer exact test were applied to see the difference of efficacy among the two groups and any influence of variables (age group, gender, tooth location, cavity classification, ICDAS score or the number of sprays required to produce local anesthesia) on the efficacy.", 'detailedDescription': "Different anesthetic techniques are used for achieving pulpal anesthesia of maxillary teeth. The most commonly used technique is the infiltration anesthesia that currently is the gold standard. However, infiltration uses a dental needle that is associated with its de merits also. This led to the discovery of novel methods to anesthetize teeth with smaller diameter needles or computerized delivery of local anesthesia. Recently tetracaine and oxymetazoline were used as local anesthetic agents in the form of an intranasal spray to achieve pulpal anesthesia of maxillary teeth. However tetracaine has its share of demerits, therefore we in our study have used lidocaine with xylometazoline in the form of an intranasal spray to achieve local anesthesia of maxillary anterior and premolar teeth for restorative procedures.\n\nOBJECTIVES:\n\nThe objective of the study was to evaluate the efficacy of 4% lidocaine and 0.1% xylometazoline intranasal spray solution as compared to injectable 2% lidocaine with 1:100,000 epinephrine solution in anesthetizing maxillary anterior \\& premolar teeth for dental restorative procedures.\n\nMETHODS:\n\nThis open label randomized controlled trial was performed at the Department of Operative Dentistry, Dr.Ishrat Ul Ebad Khan Institute of Oral Health Sciences, Dow University of Health Sciences Karachi between July 2018 and June 2020.\n\nA total of 60 patients were enrolled in the study. Consecutive sampling was done for the study participants who met the inclusion criteria. 30 patients were randomized each to lidocaine/Xylometazoline or control local anesthesia group. Group A participants received 4% Lidocaine and 0.1% Xylometazoline solution as intranasal spray while Group B participants received injectable local anesthesia. Group 'A' participants received two doses of intranasal spray anesthesia four minutes apart. Local anesthesia was then assessed by probing soft tissues adjacent to the tooth and reading was taken on the Visual Analog Scale. If the reading was '0' the cavity preparation was performed. If the VAS reading was more than '0' a third dose of intranasal spray anesthesia was delivered. Local anesthesia was again assessed after ten minutes. If profound local anesthesia was still not achieved the case was labeled as failure of intranasal spray anesthesia and local anesthesia was achieved by conventional infiltration anesthesia. For Group B participants, local anesthesia was achieved by means of conventional infiltration anesthesia. Data were recorded on a designed proforma.\n\nSPSS v16 was used to analyze the data with level of significance set at p\\<0.05. Demographic data were analyzed upon the basis of frequency and percentages. Chi-square test and Fischer exact test were applied to see the difference of efficacy among the two groups and any influence of variables (age group, gender, tooth location, cavity classification, ICDAS score or the number of sprays required to produce local anesthesia) on the efficacy."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'INCLUSION CRITERIA\n\n* Adults aged 18-40 years,\n* Patients having a vital maxillary premolar, canine or incisor.\n* Patients having Class 1,2,3,4 or 5 restorations (G.V. Black).95\n* Patients having heart rate between 55 and 100 beats per min.\n* Patients with a seated Systolic blood pressure between 95 and 150 mm Hg and diastolic blood pressure between 60 and 100 mm of Hg. (Although short-term use of topical alpha-2 agonists like xylometazoline has no systemic toxicity and are available as over the counter drugs but long-term abuse has been reported to cause systemic vasoconstriction and cardiovascular complications like hypertensive crisis therefore the cut off limit has been selected for blood pressure).\n* Teeth with no radiographic evidence of pulpal or periapical pathosis.\n* Patients having ICDAS caries detection score of 4, 5 or 6.\n* Patients who fulfilled alcohol sniff test criterion.\n\nEXCLUSION CRITERIA\n\n* Patients with Upper respiratory tract infection.\n* Patients with Uncontrolled thyroid disease.\n* Patients having a known allergy to any of the components used in the solution.\n* Pregnant or breast feeding patients.\n* Those patients having 5 or more nosebleeds per month.\n* Patients who received any local anesthetic/analgesic within 24 hours of study drug administration.'}, 'identificationModule': {'nctId': 'NCT04732104', 'briefTitle': 'Efficacy of Lidocaine and Xylometazoline Intranasal Spray in Anesthetizing Maxillary Teeth', 'organization': {'class': 'OTHER', 'fullName': 'Dow University of Health Sciences'}, 'officialTitle': 'Efficacy of Lidocaine and Xylometazoline Intranasal Spray in Anesthetizing Maxillary Teeth: An Open Label Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'UWahid'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'intranasal spray anesthesia', 'description': 'intranasal lidocaine lidocaine 4% topical', 'interventionNames': ['Drug: Lidocaine topical']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'injectable local anesthesia', 'description': 'gold standard infiltration local anesthesia (2% lidocaine with 1:100,000 epinephrine)', 'interventionNames': ['Drug: Lidocaine Hydrochloride']}], 'interventions': [{'name': 'Lidocaine topical', 'type': 'DRUG', 'otherNames': ['xylometazoline intranasal OTC decongestant'], 'description': 'intranasal spray anesthesia will be administered for achieving pulpal local anesthesia of maxillary anterior and premolar teeth. Xylometazoline OTC decongestant will be used to prolong the duration of anesthesia', 'armGroupLabels': ['intranasal spray anesthesia']}, {'name': 'Lidocaine Hydrochloride', 'type': 'DRUG', 'otherNames': ['gold standard local anesthesia'], 'description': 'injectable local anesthesia will be administered to achieve pulpal local anesthesia of maxillary anterior and premolar teeth', 'armGroupLabels': ['injectable local anesthesia']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Karachi', 'state': 'Sindh', 'country': 'Pakistan', 'facility': 'Dow University of Health Sciences', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}], 'overallOfficials': [{'name': 'Umair Wahid, MDS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'DUHS'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dow University of Health Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Umair Wahid', 'investigatorAffiliation': 'Dow University of Health Sciences'}}}}