Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-27 @ 5:41 AM
Study NCT ID:
NCT06700434
Status:
COMPLETED
Last Update Posted:
2024-11-22
First Post:
2024-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Efficacy of In-office Bleaching With Different Concentrations of Hydrogen Peroxide
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014075', 'term': 'Tooth Discoloration'}, {'id': 'D003807', 'term': 'Dentin Sensitivity'}], 'ancestors': [{'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Inclusion criteria: Females and males (least 18 years old), good oral and general health, no periodontal disease, no caries, and teeth colored A3 or darker according to the VITA Easy Shade Guide (VITA Zanhnfabrik, BadSckingrn, Germany).'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A 6-month a double-blinded randomized controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-09-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-19', 'studyFirstSubmitDate': '2024-11-15', 'studyFirstSubmitQcDate': '2024-11-19', 'lastUpdatePostDateStruct': {'date': '2024-11-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Impact of oral condition on quality of life', 'timeFrame': 'baseline and 180 days after bleaching', 'description': "The OHIP-14 questionnaire was utilized to evaluate the quality of life.24 This questionnaire consists of seven different domains and a total of 14 questions aimed at assessing one's quality of life. Responses to questions were determined by selecting one choice from a Likert scale. The scale included options like never (0 points), rarely (1 points), sometimes (2 points), often (3 points), and always (4 points), each corresponding to a certain number of points. A person's oral health-related quality of life (OHRQoL) is negatively affected when the average value of seven dimensions is higher."}], 'primaryOutcomes': [{'measure': 'Tooth Shade evaluation', 'timeFrame': 'baseline, immediately after the first bleaching session, immediately after the second whitening session (7 days after the first bleaching), 180 days after the first bleaching session', 'description': 'Tooth color was objectively evaluated using VitaTM Easy Shade V spectrophotometer (VITA Zanhnfabrik, BadSckingrn, Germany). The assesment was performed with daylight (10 a.m.to 2 p.m.) considering a 6 mm area situated in the middle section of the labial surface of the upper central incisors. In order to ensure consistency, alginate impressions were taken of the upper dental arches of each participant and stone molds were created. The custom trays were fabricated by using a 2mm Essix plate (Essix C; Dentsply, FL, USA) in a vacuum press machine (Ministar, Scheu, Iserlohn, Nordrhein-Westfalen Germany). 6 mm wide holes were drilled in the middle third of the buccal face of the central incisors on this trays to serve as a guide for using Easyshade V.'}], 'secondaryOutcomes': [{'measure': 'Tooth sensitivity evaluation', 'timeFrame': 'baseline, immediately after the first bleaching session, two hours later, and 7 days later.', 'description': 'To measure tooth sensitivity, participants indicated their discomfort level using a Visual Analog Scale (VAS).23 This scale is represented by a horizontal line measuring 10 centimeters in length. The endpoint of the line labeled "no pain" represents the absence of discomfort, while the opposite endpoint labeled "worst pain" represents the highest level of discomfort.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hydrogen Peroxide', 'In-office bleaching', 'Randomized clinical trial', 'Tooth sensitivity', 'Whitening effectiveness', 'Quality of life'], 'conditions': ['Tooth Discoloration']}, 'referencesModule': {'references': [{'pmid': '40259078', 'type': 'DERIVED', 'citation': 'Altinisik H, Nezir M. Clinical evaluation of in-office bleaching with low, medium, and high concentrate hydrogen peroxide: a 6-month a double-blinded randomized controlled trial. Clin Oral Investig. 2025 Apr 21;29(5):260. doi: 10.1007/s00784-025-06348-8.'}]}, 'descriptionModule': {'briefSummary': 'Objective: The study evaluated the longevity, effectiveness, sensitivity and impact on the oral health-related quality of life of in-office dental bleaching using low, medium, and high concentrate hydrogen peroxide.\n\nMaterial and Methods: Randomized, parallel, and double-blinded clinical trial was performed with 54 participants using18% hydrogen peroxide (HP), 20%HP, and 40%HP in-office bleaching agent. Tooth color was evaluated at baseline, after the 1st session bleaching, after the 2st session bleaching and 6 months (T5) after finishing the bleaching using spectrophotometer. Tooth sensitivity was measured with the Visual Analog Scale at baseline, immediately after bleaching, after 1 day, and after 7 days. The impact on quality of life was evaluated using the Oral Health Impact Profile (OHIP) questionnaire at baseline, and 6 months after bleaching.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '28 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women and men (at least 18 years old)\n* People with good oral and general health\n* People without periodontal disease\n* Teeth without caries\n* Teeth A3 or darker according to the VITA Easy Shade Guide (VITA Zanhnfabrik, BadSckingrn, Germany)\n\nExclusion Criteria:\n\n* Having undergone teeth bleaching procedure in the last 2 years,\n* People with tooth sensitivity,\n* Use of fixed orthodontic appliances or prostheses on upper and/or lower anterior teeth,\n* People with gingival recession,\n* Discoloration due to parafunction, tetracycline or fluorosis,\n* Smokers,\n* Tooth fracture.'}, 'identificationModule': {'nctId': 'NCT06700434', 'briefTitle': 'Clinical Efficacy of In-office Bleaching With Different Concentrations of Hydrogen Peroxide', 'organization': {'class': 'OTHER', 'fullName': 'Gazi University'}, 'officialTitle': 'Clinical Evaluation of In-office Bleaching With Low, Medium, and High Concentrate Hydrogen Peroxide: A 6-month a Double-blinded Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'TGA-2023-8355'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'HP18', 'description': 'Bleaching agent containing Hydrogen Peroxide 18% and nano- hydroxyapatite', 'interventionNames': ['Other: Bleaching treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'HP25', 'description': 'Bleaching agent containing Hydrogen Peroxide 20% and nano- hydroxyapatite', 'interventionNames': ['Other: Bleaching treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'HP40', 'description': 'Bleaching agent containing Hydrogen Peroxide 40% and nano- hydroxyapatite', 'interventionNames': ['Other: Bleaching treatment']}], 'interventions': [{'name': 'Bleaching treatment', 'type': 'OTHER', 'description': 'After the lip retractor (OptraGate, Ivoclar Vivadent, Schaan, Liechtenstein) was placed, the gingival barrier protection (Biowhiten, Biodent Ltd., İstanbul, Turkey) included in the products was applied to the upper and lower arches from premolar to premolar at the beginning of each session and removed after each treatment. The bleaching gels were applied according to the manufacturer and removed after the recommended period with a disposable surgical saliva ejector, cleaned with gauze and washed with air-water spray. Two bleaching sessions were performed at a 1-week interval. Participants were advised to maintain regular oral hygiene by brushing with toothpaste that does not contain desensitizing or whitening ingredients.\n\nHP18 is applied in 5 applications of 10 minutes per session. HP25 is applied in 3 applications of 15 minutes per session. HP40 is applied in 3 applications of 15 minutes per session.', 'armGroupLabels': ['HP18', 'HP25', 'HP40']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Gazi University', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'Associate Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Gazi University'}, {'name': 'Research assistant', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gazi University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gazi University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Hanife ALTINIŞIK', 'investigatorAffiliation': 'Gazi University'}}}}