Ignite Creation Date:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2026-04-22 @ 6:23 AM
Study NCT ID:
NCT02590835
Status:
COMPLETED
Last Update Posted:
2015-10-29
First Post:
2015-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficiency of Piezocision-assisted Orthodontic Treatment in Adult Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-28', 'studyFirstSubmitDate': '2015-10-21', 'studyFirstSubmitQcDate': '2015-10-28', 'lastUpdatePostDateStruct': {'date': '2015-10-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-10-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall treatment time measurement (in days)', 'timeFrame': '3 years', 'description': 'Comparaison of the overall treatment time between the test group (piezocision group) and the control group will be performed. It will be evaluated by measuring the time (in days) between the placement and the debond of the orthodontic appliance. The hypothesis is that piezocision accelerate orthodontic tooth movement.'}], 'secondaryOutcomes': [{'measure': 'Root resorption parameters measurements (intrabuccal radiographic in millimeters)', 'timeFrame': '3 years', 'description': 'A comparaison of orthodontic parameters (root resorption) between the test group and the control group before and after orthodontic treatment will be performed. The root resorption will be measured in intrabuccal radiographic (millimeters) on the day of the placement of this appliance and at the debond.'}, {'measure': 'Comparaison of periodontal parameters between the test group and the control group before (at baseline) and after orthodontic treatment.', 'timeFrame': '3 years'}, {'measure': 'Patient-centered outcomes (VAS questionnaire)', 'timeFrame': '7 days', 'description': 'Satisfaction post treatment using a VAS questionnaire and analgesic consumption (milligrams of paracetamol) during 7 days after the placement of the orthodontic appliance.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Adult patients', 'Patient demand for orthodontic treatment'], 'conditions': ['Tooth Overcrowding']}, 'referencesModule': {'references': [{'pmid': '27129491', 'type': 'DERIVED', 'citation': 'Charavet C, Lecloux G, Bruwier A, Rompen E, Maes N, Limme M, Lambert F. Localized Piezoelectric Alveolar Decortication for Orthodontic Treatment in Adults: A Randomized Controlled Trial. J Dent Res. 2016 Aug;95(9):1003-9. doi: 10.1177/0022034516645066. Epub 2016 Apr 29.'}]}, 'descriptionModule': {'briefSummary': 'This study was designed as a randomized controlled clinical trial to compare conventional orthodontic treatment (control group) and piezocision-assisted orthodontic treatment (PS group). Twenty-four consecutive adult patients from the Orthodontics Department of Liege University Hospital, Belgium who met the inclusion criteria were enrolled from January to October of 2013.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients (completed growth)\n* Maxillary and mandibular overcrowding\n* Patient demand for orthodontic treatment\n* Adequate dento-oral health\n* ASA I and ASA II\n* Compliance with clinic visits every 2 weeks\n\nExclusion Criteria:\n\n* A need for tooth extraction\n* A need for orthodontic temporary anchorage devices\n* A history of periodontal disease\n* Smokers\n* Altered bone metabolism (e.g., due to anti-resorptive drug, steroid or immunosuppressant use)\n* Mental or motor disabilities\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT02590835', 'briefTitle': 'Efficiency of Piezocision-assisted Orthodontic Treatment in Adult Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Liege'}, 'officialTitle': 'Efficiency of Piezocision-assisted Orthodontic Treatment in Adult Patients', 'orgStudyIdInfo': {'id': 'H2013-3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Treated with conventional orthodontics', 'interventionNames': ['Procedure: Orthodontic procedures (for both groups : Control group and Test group)']}, {'type': 'EXPERIMENTAL', 'label': 'Test group', 'description': 'subjected to piezo-assisted orthodontics', 'interventionNames': ['Procedure: Orthodontic procedures (for both groups : Control group and Test group)', 'Procedure: Piezo-assisted orthodontics (only the Test group)']}], 'interventions': [{'name': 'Orthodontic procedures (for both groups : Control group and Test group)', 'type': 'PROCEDURE', 'description': "Damon self-ligating systems (Ormco, Orange, Calif) were used for all patients. The patients were allowed to choose between clear or metal brackets. The bonding method was standardized and applied according to the manufacturer's instructions. After bracket bonding, 0.014-in copper-nickel-titanium Damon arch forms were placed. The subjects were recalled every two weeks, and the archwires were changed only when full bracket engagement was achieved. The sequence of archwires was as follows: 0.018-in, 0.014x0.025-in and 0.018x0.025-in copper nickel-titanium archwires for alignment; and 0.019x0.025-in stainless steel archwires for fine-tuning. Following the alignment steps, impressions were taken, and blinded orthodontic consultants validated appliance removal or provided advice regarding further adjustments. Alginate impressions were taken after the removal of the appliances, and both fixed and removable retainers were placed.", 'armGroupLabels': ['Control group', 'Test group']}, {'name': 'Piezo-assisted orthodontics (only the Test group)', 'type': 'PROCEDURE', 'description': 'The piezocisionTM surgery was performed one week after orthodontic appliance placement . The patients received local anesthesia in both arches, and vertical interproximal micro-incisions were created below each interdental papilla. In cases of root proximity (i.e., less than 2 mm of interdental bone), this procedure was not applied. These incisions were kept to a minimum (varying from 5 mm to 8 mm). Next, using a vertical piezoelectric device, 5-mm long and 3-mm deep corticotomies were made, and no subsequent sutures were required needed (figure 1). The patients were advised to take analgesics (paracetamol) only if necessary and to record their daily intakes for one week. Anti-inflammatories were prohibited to avoid interference with the RAP. Careful tooth brushing and the use of a mouthwash (chlorhexidine 0.2% Perio-Aid, Dentaid Benelux, Houten, Netherlands) were recommended for 7 days.', 'armGroupLabels': ['Test group']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr. France LAMBERT', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Dr. France LAMBERT', 'investigatorAffiliation': 'University of Liege'}}}}