Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2026-02-17 @ 6:24 PM
Study NCT ID:
NCT02816593
Status:
COMPLETED
Last Update Posted:
2018-02-12
First Post:
2016-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
In-office and At-home Tooth Bleaching Using Low Concentration Peroxides.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014075', 'term': 'Tooth Discoloration'}], 'ancestors': [{'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2018-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-08', 'studyFirstSubmitDate': '2016-06-21', 'studyFirstSubmitQcDate': '2016-06-24', 'lastUpdatePostDateStruct': {'date': '2018-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of color change', 'timeFrame': 'T0 (Baseline): Before treatment;T1:After one week of starting treatment;T2: After 2 weeks of starting treatment;T3: After 3 weeks of starting treatment;T4: After 30 days of starting treatment;T5:After 6 months ;T6:After 12 months', 'description': 'Visual evaluation using color scale Vita Classical 3D Master (Vita Zahnfabrik, Germany); (B1, A1, B2, D2, A2, C1, C2, D4, A3, D3, B3, A3.5, B4, C3, A4, C4) Quantitative evaluation using a spectrophotometer Easy Shade Advance ® (Wilcos Brazil).\n\nSystem CIE L \\* a \\* b \\* - L represents the value (lightness or darkness), the value of a \\* is a measure red (positive a \\*) or green (negative a \\*); the value of b \\* is a yellow extent (b \\* positive) or blue (b \\* negative) and the color difference between the color coordinate is calculated as ΔE \\* = \\[(ΔL \\*) 2 + (Δa \\*) 2 + (Δb \\*) 2\\] 1/2.'}], 'secondaryOutcomes': [{'measure': 'Tooth sensitivity assessment', 'timeFrame': 'T0 (Baseline): Before treatment;T1:After one week of starting treatment;T2: After 2 weeks of starting treatment;T3: After 3 weeks of starting treatment;T4: After 30 days of starting treatment;', 'description': 'It will be registered according to the Visual Analogue Scale (VAS), according to the criteria: none, mild, moderate or severe.'}, {'measure': 'Evaluation of gingival irritation', 'timeFrame': 'T0 (Baseline): Before treatment;T1:After one week of starting treatment;T2: After 2 weeks of starting treatment;T3: After 3 weeks of starting treatment;T4: After 30 days of starting treatment;', 'description': 'The Modified Gingival Index (IGM) The criteria are as follows: 0: Absence of inflammation;1: mild inflammation - slight change in color and texture of the gum; 2: mild inflammation involving the entire gingival margin; 3: moderate inflammation, shiny surface and edema; 4: Severe inflammation, spontaneous bleeding and severe edema.'}, {'measure': 'Impact assessment on quality of life', 'timeFrame': 'T0 (Baseline): Before treatment;T4: After 30 days of starting treatment;', 'description': 'The Brazilian version of the oral impact on daily performance (OIDP) will be used to assess the impact on quality of life. The instrument will be applied in interview form at two different times at baseline (T0) and thirty days after the first evaluation (T4) to assess the perception of changes in oral health after treatment.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['carbamide peroxide', 'Hydrogen peroxide', 'Quality of life'], 'conditions': ['Discolored Teeth']}, 'referencesModule': {'references': [{'pmid': '26057085', 'type': 'BACKGROUND', 'citation': 'Martin J, Vildosola P, Bersezio C, Herrera A, Bortolatto J, Saad JR, Oliveira OB Jr, Fernandez E. Effectiveness of 6% hydrogen peroxide concentration for tooth bleaching-A double-blind, randomized clinical trial. J Dent. 2015 Aug;43(8):965-72. doi: 10.1016/j.jdent.2015.05.011. Epub 2015 Jun 6.'}, {'pmid': '24316342', 'type': 'BACKGROUND', 'citation': 'Meireles SS, Goettems ML, Dantas RV, Bona AD, Santos IS, Demarco FF. Changes in oral health related quality of life after dental bleaching in a double-blind randomized clinical trial. J Dent. 2014 Feb;42(2):114-21. doi: 10.1016/j.jdent.2013.11.022. Epub 2013 Dec 4.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the efficacy, safety and impact on quality of life related to oral health of home and office tooth whitening techniques in young individuals.', 'detailedDescription': 'The aim of this study is to evaluate the efficacy, safety and impact on quality of life related to oral health of tooth whitening techniques in young individuals. It will be a randomized, parallel and single blind. Participants are divided into three groups (n = 30) according to bleaching technique to be performed (G1 = Office / hydrogen peroxide 6%; G2 = Office / hydrogen peroxide 15%; G3 = Home / carbamide peroxide 10%). The color of the teeth will be evaluated in seven different times, using the color scale Vita Master Classic 3D and spectrophotometer Vita Easy Shade Advance. IGM (1986) - the presence of tooth sensitivity by visual analogue scale and gingival security through modified gingival index will be evaluated. The impact of bleaching quality of life will be assessed using the Brazilian version of the oral impact on daily performance (OIDP). The instrument will be applied in interview form at two different times at baseline (T0) and thirty days after the first evaluation (T4). Statistical analysis include descriptive analysis and testing to compare the two bleaching techniques as the color change, sensitivity, gum irritation and impact on quality of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* tooth color ranging from A3 or darker, teeth with no stains and restorations without whitening experience\n\nExclusion Criteria:\n\n* participants with gingivitis and periodontal disease, the total biofilm accumulation greater than 30%, severe crowding dental, smoking with tooth sensitivity and pregnant women.'}, 'identificationModule': {'nctId': 'NCT02816593', 'briefTitle': 'In-office and At-home Tooth Bleaching Using Low Concentration Peroxides.', 'organization': {'class': 'OTHER', 'fullName': 'Federal University of Minas Gerais'}, 'officialTitle': 'In-office and At-home Tooth Bleaching Using Low Concentration Peroxides.: Effectiveness, Security and Impact on Quality of Life Related to Oral Health', 'orgStudyIdInfo': {'id': 'FUMinasGerais01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1 - HP 6%', 'description': 'Group 1: Experimental: Office; hydrogen peroxide 6%,', 'interventionNames': ['Drug: hydrogen peroxide 6%']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2 - HP 15%', 'description': 'Group 2: Experimental: Office; hydrogen peroxide 15%,', 'interventionNames': ['Drug: hydrogen peroxide 15%']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 3 - CP 10%', 'description': 'Group 3: Control: Homemade; Carbamide Peroxide 10%,', 'interventionNames': ['Drug: Carbamide Peroxide 10%']}], 'interventions': [{'name': 'hydrogen peroxide 6%', 'type': 'DRUG', 'otherNames': ['Group 1 - HP 6%'], 'description': 'Office; hydrogen peroxide 6%, 3 sessions of 20 minutes of application', 'armGroupLabels': ['Group 1 - HP 6%']}, {'name': 'hydrogen peroxide 15%', 'type': 'DRUG', 'otherNames': ['Group 2 - HP 15%'], 'description': 'Office; hydrogen peroxide 15%, 3 sessions of 20 minutes of application', 'armGroupLabels': ['Group 2 - HP 15%']}, {'name': 'Carbamide Peroxide 10%', 'type': 'DRUG', 'otherNames': ['Group 3 - CP 10%'], 'description': 'Homemade; Carbamide Peroxide 10%, 2 hours per day for 21 days', 'armGroupLabels': ['Group 3 - CP 10%']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Belo Horizonte', 'state': 'Minas Gerais', 'country': 'Brazil', 'facility': 'Federal University of Minas Gerais', 'geoPoint': {'lat': -19.92083, 'lon': -43.93778}}], 'overallOfficials': [{'name': 'Nayara Kelly Lyrio Ferraz', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'PhD student of Federal University of Minas Gerais'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal University of Minas Gerais', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor IV, Department of Restorative Dentistry at the Federal University of Minas Gerais', 'investigatorFullName': 'Cláudia Silami de Magalhães', 'investigatorAffiliation': 'Federal University of Minas Gerais'}}}}