Ignite Creation Date:
2025-12-24 @ 10:53 PM
Ignite Modification Date:
2026-02-23 @ 4:54 AM
Study NCT ID:
NCT06582069
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-09-03
First Post:
2024-08-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bleaching Effect of Solo and Combined Kiwi Extract and Ozone and Their Impact on Enamel
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014073', 'term': 'Tooth Bleaching'}], 'ancestors': [{'id': 'D004955', 'term': 'Esthetics, Dental'}, {'id': 'D003813', 'term': 'Dentistry'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-30', 'studyFirstSubmitDate': '2024-08-24', 'studyFirstSubmitQcDate': '2024-08-30', 'lastUpdatePostDateStruct': {'date': '2024-09-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Color change assessment', 'timeFrame': '24 Hours', 'description': 'all participants will be requested to return after 24 hours to permit rehydration of tooth surfaces before shade assessment Tooth Shades will then record using colorimeter. The color change (ΔE) will be calculated using the formula: ΔE= {(ΔL) 2+ (Δa) 2+ (Δb)'}, {'measure': 'Color change assessment', 'timeFrame': 'one month', 'description': 'all participants will be requested to return after one month for tooth shades recording using colorimeter. The color change (ΔE) will be calculated using the formula: ΔE= {(ΔL) 2+ (Δa) 2+ (Δb) at one month'}, {'measure': 'Color change assessment', 'timeFrame': 'three month', 'description': 'all participants will be requested to return after one month for tooth shades recording using colorimeter. The color change (ΔE) will be calculated using the formula: ΔE= {(ΔL) 2+ (Δa) 2+ (Δb) at three months'}, {'measure': 'Color change assessment', 'timeFrame': 'six months', 'description': 'all participants will be requested to return after one month for tooth shades recording using colorimeter. The color change (ΔE) will be calculated using the formula: ΔE= {(ΔL) 2+ (Δa) 2+ (Δb) at six months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Discoloration, Tooth']}, 'descriptionModule': {'briefSummary': 'ozone therapy has been extensively used in dentistry to manage wounds healing, dental caries, oral lichen planus, gingivitis and periodontitis, halitosis, osteonecrosis of the jaw, post-surgical pain, plaque and biofilms, root canal treatment, dentin hypersensitivity, tempro-mandibular joint disorders and teeth whitening, And based on the above, in this study kiwi extract and ozone gas will be used individually and combined to evaluate the resultant effects on bleaching, enamel microhardness and micromorphology.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A total of the 40 participants aged between (18-35 years) with no gender prediction.\n* The participation will be entirely voluntary, and a signed statement of informed consent will be obtained prior to the start of the study.\n* Systemically healthy subject based on medical and drug histories, a subject requiring scaling and polishing with moderate calculus with at least two non-adjacent hypersensitive teeth with Schiff scale scores \\>1 with air blast stimulus.\n* Access to sound maxillary anterior teeth.\n* Vitapan classical shades should be A3 or darker and lighter shades are not included.\n\nExclusion Criteria:\n\n* Participants with poor oral hygiene.\n* Participants with missing anterior teeth.\n* Participants with unrealistic expectations.\n* Participants with dental caries, those undergoing orthodontic treatment.\n* Participants with a history of periodontal treatment, pregnant or lactating women and individuals with a history of asthma.\n* Those who are allergic to kiwi or ozone skin therapy were excluded from the study.\n* Smokers are excluded from the present study.'}, 'identificationModule': {'nctId': 'NCT06582069', 'briefTitle': 'Bleaching Effect of Solo and Combined Kiwi Extract and Ozone and Their Impact on Enamel', 'organization': {'class': 'OTHER', 'fullName': 'Al-Azhar University'}, 'officialTitle': 'Bleaching Effect of Solo and Combined Kiwi Extract and Ozone and Their Impact on Enamel', 'orgStudyIdInfo': {'id': '24/3/2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'bleaching with 2% kiwi extract.', 'description': 'The fresh pulpy kiwi will be bought 200 gm of kiwi fruits were cleaned, cut into round shapes and blended with 15 mL of distilled water in a blender to obtain about 50 mL of kiwi concentrate.\n\nThis concentrate will be filtered and then transferred into a cooling centrifuge to be processed at 2000 rpm for about 20 minutes at a temperature of 40°C.\n\nThe extract thus collected will be stored at 4°C till further use.', 'interventionNames': ['Device: Bleaching']}, {'type': 'EXPERIMENTAL', 'label': 'bleaching using 2,350 ppm ozone gas.', 'description': 'A 2,350 ppm ozone concentration at a 615 cc per minute flow rate will be supplied by a well-known ozone producing machine.\n\nThe ppm of ozone supplied will be verified via an ozone detection device, and the ozone flow rate will be verified by a flow meter directly before the start of the experiment.\n\nOzone gas will be distributed to the tooth surfaces through special trays to assure a perfect seal to prevent any ozone leakage and to be safely employed to humans', 'interventionNames': ['Device: Bleaching']}, {'type': 'EXPERIMENTAL', 'label': 'bleaching with 2% kiwi extract followed By 2,350 ppm ozone gas.', 'description': 'The fresh pulpy kiwi will be bought 200 gm of kiwi fruits were cleaned, cut into round shapes and blended with 15 mL of distilled water in a blender to obtain about 50 mL of kiwi concentrate.\n\nThis concentrate will be filtered and then transferred into a cooling centrifuge to be processed at 2000 rpm for about 20 minutes at a temperature of 40°C.\n\nThe extract thus collected will be stored at 4°C till further use. A 2,350 ppm ozone concentration at a 615 cc per minute flow rate will be supplied by a well-known ozone producing machine.\n\nThe ppm of ozone supplied will be verified via an ozone detection device, and the ozone flow rate will be verified by a flow meter directly before the start of the experiment.\n\nOzone gas will be distributed to the tooth surfaces through special trays to assure a perfect seal to prevent any ozone leakage and to be safely employed to humans.', 'interventionNames': ['Device: Bleaching']}, {'type': 'EXPERIMENTAL', 'label': 'bleaching with 38% hydrogen peroxide.', 'description': 'Application of 38% H2O2 gel for 20 minutes. Then, the H2O2 gel will be removed, and teeth will be sprayed for 10 seconds with water from a 3-in-1 syringe', 'interventionNames': ['Device: Bleaching']}], 'interventions': [{'name': 'Bleaching', 'type': 'DEVICE', 'description': 'Bleaching', 'armGroupLabels': ['bleaching using 2,350 ppm ozone gas.', 'bleaching with 2% kiwi extract followed By 2,350 ppm ozone gas.', 'bleaching with 2% kiwi extract.', 'bleaching with 38% hydrogen peroxide.']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Al-Azhar University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Teaching Assistant', 'investigatorFullName': 'Mona Bedier El Lakanay', 'investigatorAffiliation': 'Al-Azhar University'}}}}