Ignite Creation Date:
2025-12-24 @ 5:23 PM
Ignite Modification Date:
2026-01-01 @ 4:40 PM
Study NCT ID:
NCT05213650
Status:
COMPLETED
Last Update Posted:
2023-07-27
First Post:
2022-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cleaning Agents Impact on Invisalign Aligners: A Cross-Over Randomized Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'It will be shared with the participants of the study that when their treatment is finished, the plaques will be requested back and a study will be carried out on these plaques to affect the plaques from the process. However, the information that the study is on the effects of the cleaning agent they use will not be shared. Therefore, the participants do not have information about being in a group related to plaque cleaning efficiency.'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'controlled clinical trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-26', 'studyFirstSubmitDate': '2022-01-17', 'studyFirstSubmitQcDate': '2022-01-17', 'lastUpdatePostDateStruct': {'date': '2023-07-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Colour change (Delta E)_control', 'timeFrame': '2 week', 'description': 'Delta E of 12 clear aligners of patients who clean their plaques only with liquid soap and a toothbrush'}, {'measure': 'Colour change (Delta E)_Invisalign non-abrasive toothpaste patients', 'timeFrame': '2 week', 'description': 'Delta E of 12 clear aligners of patients who clean their plaques with non-abrasive toothpaste and toothbrush'}, {'measure': 'Colour change (Delta E)_ Invisalign abrasive toothpaste patients', 'timeFrame': '2 week', 'description': 'lDelta E of 12 clear aligners of patients who clean their plaque with abrasive toothpaste and toothbrush'}, {'measure': 'Colour change (Delta E) Invisalign Efferdent patients', 'timeFrame': '2 week', 'description': 'Delta E of 12 clear aligners of patients who clean their plaques with liquid soap and use Efferdent antibacterial cleaning tablet once a week'}, {'measure': 'Colour change (Delta E) Invisalign Cleaning Crystals patients', 'timeFrame': '2 week', 'description': 'Delta E of 12 clear aligners of patients who clean their plaques with liquid soap and use Invisalign Cleaning Crystals tablet once a week'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Aligner Staining']}, 'referencesModule': {'references': [{'pmid': '30264270', 'type': 'BACKGROUND', 'citation': 'Papadimitriou A, Mousoulea S, Gkantidis N, Kloukos D. Clinical effectiveness of Invisalign(R) orthodontic treatment: a systematic review. Prog Orthod. 2018 Sep 28;19(1):37. doi: 10.1186/s40510-018-0235-z.'}, {'pmid': '19121497', 'type': 'BACKGROUND', 'citation': 'Kravitz ND, Kusnoto B, BeGole E, Obrez A, Agran B. How well does Invisalign work? A prospective clinical study evaluating the efficacy of tooth movement with Invisalign. Am J Orthod Dentofacial Orthop. 2009 Jan;135(1):27-35. doi: 10.1016/j.ajodo.2007.05.018.'}, {'pmid': '41188779', 'type': 'DERIVED', 'citation': 'Kilic B, Canpolat S, Ozturk M. Comparative evaluation of the effect of different cleaning agents on colour and surface roughness of Invisalign clear aligners: a cross-over randomized controlled trial. BMC Oral Health. 2025 Nov 4;25(1):1745. doi: 10.1186/s12903-025-06928-w.'}]}, 'descriptionModule': {'briefSummary': "Today, the increasing aesthetic expectations of the patients, showing its effect in the field of orthodontics, leads to the orientation towards aesthetic materials. The Invisalign system is also polyurethane for aesthetic purposes.\n\nIt is a series of transparent plaques personalized to the patient's problems. However, the transparent structure of the plaque increases the importance of its cleanliness.\n\nThere are many studies evaluating the removal of bacterial biofilm from plaques. However There are minimal studies evaluating the effect of the materials used for cleaning on the light transmittance, which has a significant effect on the aesthetics of the plaques.\n\nThe aim of this study is to compare 5 different agents' effects on colour change.\n\nThe work created will be divided into 5 groups according to the cleaning materials used.\n\nOne of the cleaning agents will be assigned by lot and will be used while the treatment processes are continuing.\n\nThe colour measurement will be carried out using the VITA Easyshade Compact spectrophotometer (VITA Zahnfabrik DEASYC220, Bad Sackingen, Germany). To prevent external light interference and keep the measurement head in a fixed position for each measurement, a special cubic box with a 3 mm radius entrance was created. The head of the device was firmly attached to the box lid with black tape to increase light-tightness. The colour measurement will be performed from the occlusal region of the second premolar tooth on the aligners, which will be placed on a standard white background. The colour measurement will be carried out as received and after the aligners were used in the patient's mouth for 2 weeks. Prior to measurements, the spectrophotometer will be calibrated according to the manufacturer's instructions. Each measurement will be repeated three times, and the average value will be determined. The Commision de l'Eclairage (CIE) Lab\\* system will be used for colour measurements. This system uses three parameters to define colour. The L\\* coordinate is a brightness measure that ranges from 0 (black) to 100 (white); the a\\* coordinate is horizontal and shows chromatic coordinates between red (+) and green (-), and the b\\* coordinate is also horizontal and extends in the direction of yellow (b+) and blue (b-). To determine the colour difference, a formula (Formula 1) will be used. ∆L, ∆a, and ∆b values will be calculated by subtracting the starting measurements (L0, a0, b0) from the final measurements (L1, a1, b1). The ∆E value will be calculated using these values, and the colour difference between groups will be compared.\n\n∆E2-1 = \\[(∆L)2 + (+ (∆a)2 + (∆b)2\\]1/2= \\[(L1-L0)2 + (a1-a0)2 + (b1-b0)2\\]1/2 The formula proposed by Filho and da Silva will be used to convert ΔE values to National Bureau of Standards (NBS) values. NBS unit = ΔE\\* × 0.92. The ΔE values will be converted to their clinical significance using the NBS system.\n\nAccording to the results of the research, the colour change of the agents used to clean Invisalign aligners will be determined.\n\nThe use of agents that have a minor effect on aesthetics can be considered ideal according to the results of the study", 'detailedDescription': "In recent years, following the developments in the field of orthodontics, the participation and expectations of patients in treatment have also changed. Conventional orthodontic brackets may cause aesthetic concerns in patients. The use of aesthetic materials and techniques aimed at overcoming such limitations has increased.\n\nAn orthodontic treatment system made with a material made of polyurethane was introduced for the first time in 1998 as an alternative to conventional brackets. This system uses CAD/CAM technology to produce serial plates personalized to the treatment process.\n\nIt is very important to clean these appliances for aesthetic reasons and to prevent bacteria from accumulating and becoming a focus of infection for the oral cavity. If plaques are not cleaned regularly, they can act as a reservoir for bacteria, leading to periodontal diseases, cavities and bad breath.\n\nIn the treatment of clear plaque, the patient is asked not to eat or drink anything other than water while the plaques are in the mouth. However, despite all the recommendations, patients sometimes do not comply with these and may consume coloring drinks while the plaques are in their mouths. This situation causes changes in the polymer of the material and adversely affects the aesthetics, which is the main advantage of clear aligner treatment.\n\nColor stability of clear aligners remain critical considerations for both patients and clinicians. Despite the increasing cost, patients' desire for transparent aligners is due to the fact that these plates have almost no transparency in the mouth, so maintaining the original colour of the aligners is an important issue.\n\nAlthough there are many studies in the literature evaluating the removal of bacterial biofilm after cleaning of clear plaques, there are very limited studies evaluating the Colour change of plaques.\n\nIn the light of this information, the aim of this research is to evaluate the colour change of transparent plaques, which is a polyurethane material, using 5 different cleaning methods. The cleaning methods to be used for this; toothpaste, whitening toothpaste, Corega Pro Guard \\& Retainer cleaning tablet, Efferdent antibacterial cleaning tablet and liquid soap."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '7 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Inclusion criteria for the study:\n\n 1. No active periodontal disease\n 2. No caries\n 3. No systemic disease\n 4. Patients who do not use any medication will be included in the study.\n 5. Patients who will use more than 20 transparent plates in their treatment-\n\nExclusion Criteria:\n\n1. Smoking (more than 1 pack per day)\n2. Patients consuming dyes such as coffee, tea, beer and red wine more than 2 times a day\n3. Patients using less than 20 clear plates in their treatment'}, 'identificationModule': {'nctId': 'NCT05213650', 'acronym': 'İnvisalign', 'briefTitle': 'Cleaning Agents Impact on Invisalign Aligners: A Cross-Over Randomized Trial', 'organization': {'class': 'OTHER', 'fullName': 'Bezmialem Vakif University'}, 'officialTitle': 'Comparative Evaluation of Cleaning Agents on Color and Roughness of Invisalign Clear Aligners: A Cross-Over Randomized Trial', 'orgStudyIdInfo': {'id': 'BezmialemVU invisalign'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Invisalign control patients (liquid soap)', 'description': 'Patients who clean their plaques only with liquid soap and toothbrush'}, {'type': 'EXPERIMENTAL', 'label': 'Invisalign non-abrasive toothpaste patients', 'description': 'Patients who clean their plaque with non-abrasive toothpaste and toothbrush', 'interventionNames': ['Other: non-abrasive toothpaste']}, {'type': 'EXPERIMENTAL', 'label': 'Invisalign abrasive toothpaste patients', 'description': 'Patients who clean their plaque with abrasive toothpaste and toothbrush', 'interventionNames': ['Other: abrasive toothpaste']}, {'type': 'EXPERIMENTAL', 'label': 'Invisalign Efferdent patients', 'description': 'Patients who clean their plaques with liquid soap and use Efferdent antibacterial cleaning tablet once a week', 'interventionNames': ['Other: Efferdent']}, {'type': 'EXPERIMENTAL', 'label': 'Invisalign Cleaning Crystals patients', 'description': 'Patients who clean their plaques with liquid soap and use Invisalign Cleaning Crystals tablet once a week', 'interventionNames': ['Other: Cleaning Crystals']}], 'interventions': [{'name': 'non-abrasive toothpaste', 'type': 'OTHER', 'otherNames': ['cleaning agent'], 'description': 'Aligners should be cleaned at least once a day, but twice is preferred to prevent them from changing color or having a bad odor. They should be treated just like teeth and cleaned often, especially after eating and drinking.Usually, dentists advise their patients to clean their plaques with only liquid soap, toothbrush and water. Non-abrasive toothpaste will be used as intervention to aligner cleaning during invisalign treatment.', 'armGroupLabels': ['Invisalign non-abrasive toothpaste patients']}, {'name': 'abrasive toothpaste', 'type': 'OTHER', 'otherNames': ['cleaning agent'], 'description': 'Aligners should be cleaned at least once a day, but twice is preferred to prevent them from changing color or having a bad odor. They should be treated just like teeth and cleaned often, especially after eating and drinking.Usually, dentists advise their patients to clean their plaques with only liquid soap, toothbrush and water. Abrasive toothpaste will be used as intervention to aligner cleaning during invisalign treatment.', 'armGroupLabels': ['Invisalign abrasive toothpaste patients']}, {'name': 'Efferdent', 'type': 'OTHER', 'otherNames': ['cleaning agent'], 'description': 'Aligners should be cleaned at least once a day, but twice is preferred to prevent them from changing color or having a bad odor. They should be treated just like teeth and cleaned often, especially after eating and drinking.Usually, dentists advise their patients to clean their plaques with only liquid soap, toothbrush and water.The Efferdent tablet will be used once a week as an intervention to aligner cleaning during invisalign treatment.', 'armGroupLabels': ['Invisalign Efferdent patients']}, {'name': 'Cleaning Crystals', 'type': 'OTHER', 'otherNames': ['cleaning agent'], 'description': 'Aligners should be cleaned at least once a day, but twice is preferred to prevent them from changing color or having a bad odor. They should be treated just like teeth and cleaned often, especially after eating and drinking.Usually, dentists advise their patients to clean their plaques with only liquid soap, toothbrush and water. Invisalign Cleaning Crystals will be used once a week as an intervention to aligner cleaning during invisalign treatment.', 'armGroupLabels': ['Invisalign Cleaning Crystals patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34093', 'city': 'Fatih', 'state': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Banu Kılıç', 'geoPoint': {'lat': 41.0225, 'lon': 28.94083}}], 'overallOfficials': [{'name': 'Banu Kılıç', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bezmialem Vakıf Üniversitesi'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bezmialem Vakif University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Banu Kılıç', 'investigatorAffiliation': 'Bezmialem Vakif University'}}}}