Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2025-12-26 @ 1:49 AM
Study NCT ID:
NCT04051905
Status:
COMPLETED
Last Update Posted:
2020-03-10
First Post:
2019-08-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bone Loss in Posterior Mandible Postextraction Sockets
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2020-03-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-09', 'studyFirstSubmitDate': '2019-08-08', 'studyFirstSubmitQcDate': '2019-08-08', 'lastUpdatePostDateStruct': {'date': '2020-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cone beam diagnostic examination', 'timeFrame': 'Day diagnostic (Day 0)', 'description': 'Cone beam diagnostic examination: Millimeter measurements will be taken at Day 0.\n\nThis examination is an X-ray technique that uses a cone-shaped radiation beam. The measurements will be made on radiographic examinations\n\nMucous measures\n\n* Vestibular cortical Distance, lingual cortical measured in the middle of the cell\n* Depth of the slot lingual cortical side\n* Depth of the cell vestibular cortical side\n\nBone measures\n\n* Thickness of the lingual cortical measured caliper 2 millimeters under the rim\n* Vestibular cortical thickness measured with calipers 2 millimeters under the rim\n* Depth of the slot lingual cortical side\n* Depth of the cell vestibular cortical side'}], 'secondaryOutcomes': [{'measure': 'Cone beam pre implant examination', 'timeFrame': '5 or 6 months', 'description': 'Cone beam pre implant examination : millimeter measurements will be taken at 5 or 6 months.\n\nThis examination is an X-ray technique that uses a cone-shaped radiation beam. The measurements will be made on radiographic examinations\n\nMucous measures\n\n* Vestibular cortical Distance, lingual cortical measured in the middle of the cell\n* Depth of the slot lingual cortical side\n* Depth of the cell vestibular cortical side\n\nBone measures\n\n* Thickness of the lingual cortical measured caliper 2 millimeters under the rim\n* Vestibular cortical thickness measured with calipers 2 millimeters under the rim\n* Depth of the slot lingual cortical side\n* Depth of the cell vestibular cortical side'}, {'measure': 'Clinical measures', 'timeFrame': 'Day of surgery', 'description': 'Clinical measures on the day of surgery\n\nBone measures\n\n* Thickness of the lingual cortical measured caliper 2 millimeters under the rim\n* Vestibular cortical thickness measured with calipers 2 millimeters under the rim\n* Cortical vestibular cortical lingual distance, measured in the middle of the cell\n* Depth of the slot lingual cortical side\n* Depth of the cell vestibular cortical side\n\nMucous measure:\n\n* Gum buccal keratinized\n* Keratinized gingiva lingual\n* Cortical vestibular cortical lingual distance measured in the middle of the cell'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Regeneration'], 'conditions': ['Guided Bone']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the bone loss after extraction. The surgery protocol is flapless, and the teeth are mandibular premolars or molars leaving sockets with 4 walls intact or at least 3 walls intact and the buccal wall at 80% . This study will include 40 patients', 'detailedDescription': 'Primary objective :\n\nEstimate the percentage of bone volume loss o and the percentage thickness loss of the buccal and palatal cortical for patients who underwent natural healing in the mandibular molar and premolar areas.\n\nMethods :\n\nBefore tooth extraction of a premolar or molar in mandibular area by flapless technique, a CBCT preoperative is performed to verify the integrity of cortical and measure the height and width of the residual cavity. Caliper measurements will also be performed during surgery in order to integrate also the thickness of the bone tables and gingival thickness.\n\nAfter natural healing , the pre-implant scan performed at six months postoperatively will measure the height and width of the grafted cell, to compare measurements and evaluate the dynamics of alveolar resorption.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Population of patients aged between 18 and 80 years with one to two posterior mandibular teeth to extract in absence of bone graft and able to benefit from a flapless technique.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\n* patients requiring tooth extraction\n* aged 18 to 80\n* Patients showing no indication against-General to surgery\n\nExclusion criteria\n\n* Patient with against-indication for surgical treatment.\n* Patients with an important loss of vestibular cortical\n* Patients requiring and accepting a bone graft\n* Unstabilized periodontal disease or aesthetic indication.\n* Inability to maintain a good level of oral hygiene and good cooperation.\n* Higher tobacco consumption has 10cig / day\n* Acute dental infection'}, 'identificationModule': {'nctId': 'NCT04051905', 'briefTitle': 'Bone Loss in Posterior Mandible Postextraction Sockets', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Evolution of Bone Volume in the Mandibular Posterior Area After Natural Healing and Flapless Technique', 'orgStudyIdInfo': {'id': 'RECHMPL19_0395'}}, 'contactsLocationsModule': {'locations': [{'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'UHMontpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'overallOfficials': [{'name': 'Philippe BOUSQUET, MCU PH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Montpellier'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'NC'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}