Ignite Creation Date:
2025-12-26 @ 11:13 PM
Ignite Modification Date:
2025-12-26 @ 11:13 PM
Study NCT ID:
NCT03566212
Status:
COMPLETED
Last Update Posted:
2018-10-05
First Post:
2018-05-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Camouflaged Syringe vs Conventional Syringe
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'local anesthesia is administered by using either camouflaged syringe or conventional syringe and was compared for reduction in anxiety levels in both groups'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2017-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-03', 'studyFirstSubmitDate': '2018-05-30', 'studyFirstSubmitQcDate': '2018-06-11', 'lastUpdatePostDateStruct': {'date': '2018-10-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-08-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anxiety levels by using the Chotta Bheem and Chutki scale', 'timeFrame': 'after 5 minutes', 'description': "Anxiety levels in both camouflaged group and conventional group in the children were scored before and after the procedure using the Chotta Bheem and Chutki scale. The Chotta Bheem and Chutki (CBC) scale comprises two separate cards: one for boys and the other for girls. The cartoon characters of Chotta Bheem and Chutki were chosen to depict various emotions for boys and girls respectively. Each card consists of a series of six figures depicting sequentially various emotions from 'happy' to 'unhappy and running away' of the cartoon character. Score 1 is happy face, score 2 is sad face, score 3 is crying face, score 4 is angry face, score 5 is shouting and score 6 is running. So, here, score 1 depicts patient is happy whereas as score increases anxiety level also increases which denotes that patient is unhappy."}], 'secondaryOutcomes': [{'measure': 'Behavior rating by using Frankel Behaviour rating scale', 'timeFrame': 'after 10 minutes', 'description': "Behavior rating in both camouflaged group and conventional group in the children were scored before and after the procedure using Frankel Behaviour rating scale. Behavior rating scale comprised of scores from definitely negative to definitely positive. 'Double negative'(--) i.e. 'definitely negative' score indicates that patient refuses treatment, 'negative score'(-) indicates that patient is reluctant to accept treatment, there is evidence of negative attitude but not pronounced, ' positive score' (+) indicates that patient accepts treatment though there is cautious with treatment but follows dentist's instructions cooperatively whereas ' definitely positive score' (++) indicates that there is good raport of patient with dentist and accepts the treatment with enjoyment. So, as score increases from definitely negative to definitely positive, behaviour of children also increases."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Anxiety', 'Camouflaged syringe', 'Conventional syringe'], 'conditions': ['Dental Anxiety', 'Behavior']}, 'descriptionModule': {'briefSummary': 'This study evaluates the efficacy of Camouflage syringe vs Conventional syringe in reducing Dental Anxiety and increasing behaviour rating.Half of the participants received local anesthesia using camouflaged syringe, while others received using conventional syringe.', 'detailedDescription': 'Dental anxiety and phobia result in avoidance of dental care. Since the injection itself can be painful, pain reduction procedures warrant continued investigation. Camouflage design deals with the visual impact of the needle and syringe though the tactile sensation remains unaltered. In our study, post treatment anxiety levels in camouflaged syringe was reduced as compared to conventional syringe group and this might be because, patients with low anxiety tend to have high pain thresholds.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '3 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* retained teeth,\n* badly carious teeth,\n* mobile teeth\n* requiring a dental procedure under local anesthesia were selected.\n\nExclusion Criteria:\n\n* Mentally challenged children\n* those with medical conditions contraindicating the use of local anesthesia and / or surgical procedures'}, 'identificationModule': {'nctId': 'NCT03566212', 'acronym': 'ECC', 'briefTitle': 'Efficacy of Camouflaged Syringe vs Conventional Syringe', 'organization': {'class': 'OTHER', 'fullName': 'Saraswati-Dhanwantari Dental College & Hospital'}, 'officialTitle': 'Clinical Comparative Study of Efficacy of Camouflaged Syringe vs Conventional Syringe in Reducing Dental Anxiety', 'orgStudyIdInfo': {'id': 'SaraswatiDhanwantari'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'conventional syringe', 'description': 'Individuals requiring local anesthesia for dental treatment were treated in first group by using conventional syringe.', 'interventionNames': ['Device: Conventional Syringe']}, {'type': 'EXPERIMENTAL', 'label': 'camouflaged syringe', 'description': 'Individuals requiring local anesthesia for dental treatment were treated in second group by using camouflage syringe.', 'interventionNames': ['Device: Camouflage Syringe']}], 'interventions': [{'name': 'Conventional Syringe', 'type': 'DEVICE', 'description': 'local anesthesia was administered in first group using Conventional syringe', 'armGroupLabels': ['conventional syringe']}, {'name': 'Camouflage Syringe', 'type': 'DEVICE', 'description': 'local anesthesia was administered in second group using Camouflage syringe', 'armGroupLabels': ['camouflaged syringe']}]}, 'contactsLocationsModule': {'locations': [{'zip': '431401', 'city': 'Parbhani', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Dr Sneha D Suwarnkar', 'geoPoint': {'lat': 19.26855, 'lon': 76.77081}}], 'overallOfficials': [{'name': 'Sneha D Suwarnkar, MDS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Saraswati Dhanwantari Dental College and Hospital, Parbhani'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'it will be dependent on publication'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sneha D. Suwarnkar', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Sneha D. Suwarnkar', 'investigatorAffiliation': 'Saraswati-Dhanwantari Dental College & Hospital'}}}}