Ignite Creation Date:
2025-12-24 @ 2:14 PM
Ignite Modification Date:
2025-12-24 @ 2:14 PM
Study NCT ID:
NCT05340595
Status:
COMPLETED
Last Update Posted:
2022-04-28
First Post:
2022-04-07
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Primer Application on the Lingual Retainer
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']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2016-07-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-21', 'studyFirstSubmitDate': '2022-04-07', 'studyFirstSubmitQcDate': '2022-04-15', 'lastUpdatePostDateStruct': {'date': '2022-04-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-11-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bond Failure Rate of a Mandibular Bonded Lingual Retainer', 'timeFrame': '24 months', 'description': 'Bond Failure Rate of a Mandibular Bonded Lingual Retainer'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dental Bonding', 'Orthodontic Retainers']}, 'referencesModule': {'references': [{'pmid': '18216373', 'type': 'BACKGROUND', 'citation': 'Elekdag-Turk S, Isci D, Turk T, Cakmak F. Six-month bracket failure rate evaluation of a self-etching primer. Eur J Orthod. 2008 Apr;30(2):211-6. doi: 10.1093/ejo/cjm119. Epub 2008 Jan 23.'}, {'pmid': '15014415', 'type': 'BACKGROUND', 'citation': 'Sfondrini MF, Cacciafesta V, Scribante A, De Angelis M, Klersy C. Effect of blood contamination on shear bond strength of brackets bonded with conventional and self-etching primers. Am J Orthod Dentofacial Orthop. 2004 Mar;125(3):357-60. doi: 10.1016/j.ajodo.2003.09.022.'}]}, 'descriptionModule': {'briefSummary': "Background: The aim of this study was to examine the effect of self-etch primer (SEP) application on the bond failure rate of a mandibular bonded lingual retainer over 24 months.\n\nMaterials and Methods: After the removal of the orthodontic appliances, the lingual retainers, which were made of six-stranded stainless steel wire 0.0215 inches in diameter, wiil bent and bond onto the lingual surface of all mandibular anterior teeth. The study will performed using a split-mouth design. In the study group, the SEP will be administired to the teeth's lingual surfaces. In the control group, they will etch using 37% phosphoric etchant liquid gel. After etching, the primer wiil be applied. The adhesive resin was applied and the lingual retainer was fitted. The patients will be re-valuated over 24 months. The first bond failures and the amount of adhesive remaining on the tooth will be recorded as the adhesive remnant index (ARI) scores.\n\nThe chi-square test will be used to compare the bond failure rates and ARI scores between the groups. The survival rates of the retainers will be estimated using the Kaplan-Meier test. The significance level will P \\< 0.05."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '34 Years', 'minimumAge': '11 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Individuals who will continue to the retention phase after fixed orthodontic treatment,\n2. Presence of all mandibular incisor and canine teeth,\n3. Good oral hygiene,\n4. No caries,\n5. No fractures,\n6. Healthy periodontal condition,\n7. No restorations,\n8. No previous bonded retainer,\n9. No traumatic parafunctional habits such as bruxism.\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT05340595', 'briefTitle': 'Effect of Primer Application on the Lingual Retainer', 'organization': {'class': 'OTHER', 'fullName': 'Ondokuz Mayıs University'}, 'officialTitle': 'Effect of Self-Etch Primer Application on the Bond Failure Rate of a Mandibular Bonded Lingual Retainer', 'orgStudyIdInfo': {'id': '2013/17'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Control group', 'description': 'The primer (Transbond XT Primer; 3M Unitek, California) was applied in a thin and uniform coat. Then the adhesive resin (Transbond LR Light Cure Adhesive Paste; 3M Unitek, California) was administered to the lingual surface of the anterior teeth and the lingual retainer was placed in position. The adhesive resin was polymerized from two directions for a total of 20 s using a visible-light curing unit (Hilux 200, Benlioglu Dental Inc., Ankara, Turkey) with an output power of 600 mW/cm2.', 'interventionNames': ['Other: Orthodontic retainer bonding']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Study group', 'description': "In the study group, the SEP (3M Unitek, Monrovia, California) was used according to the manufacturer's instructions, namely it was administered to the lingual surfaces of the teeth and rubbed for 3 s. Then a gentle burst of dry air was delivered to thin the primer. In the control group, the lingual surfaces of the teeth were etched using 37% phosphoric etchant liquid gel (3M Espe, St Paul, Minnesota, USA) for 30 s, followed by rinsing and drying.", 'interventionNames': ['Other: Orthodontic retainer bonding']}], 'interventions': [{'name': 'Orthodontic retainer bonding', 'type': 'OTHER', 'description': "Self-etch primer (Transbond XT Primer; 3M Unitek, California) was administered to the teeth's lingual surfaces.", 'armGroupLabels': ['Control group', 'Study group']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ondokuz Mayıs University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sabahat Yazıcıoğlu', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Dr. Fethiye ÇAKMAK ÖZLÜ', 'investigatorAffiliation': 'Ondokuz Mayıs University'}}}}