Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2026-02-17 @ 4:44 PM
Study NCT ID:
NCT04178668
Status:
TERMINATED
Last Update Posted:
2023-05-25
First Post:
2019-11-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Molecular and Organizational Changes in the Human Oral Mucosa During Aging
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C112829', 'term': 'Endomet'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'whyStopped': 'Difficulty in recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-03-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2021-10-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-23', 'studyFirstSubmitDate': '2019-11-13', 'studyFirstSubmitQcDate': '2019-11-25', 'lastUpdatePostDateStruct': {'date': '2023-05-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vibrational marker of the oral mucosa: collagen 1 fraction indicator', 'timeFrame': 'Day 0', 'description': 'collagen 1 fraction indicator measured by Fourier-transform infrared spectroscopy. It corresponds to the ratio of the band area 1338 cm-1/1750-1000 cm-1'}, {'measure': 'Vibrational marker of the oral mucosa : collagen 2 fraction indicator', 'timeFrame': 'Day 0', 'description': 'collagen 2 fraction indicator measured by Fourier-transform infrared spectroscopy. It corresponds to the ratio of the band area 1202 cm-1/1750-1000 cm-1'}, {'measure': 'Thermal marker of the oral mucosa : percentage of open water', 'timeFrame': 'Day 0', 'description': 'percentage of open water'}, {'measure': 'Thermal marker of the oral mucosa: percentage of water related', 'timeFrame': 'Day 0', 'description': 'percentage of water related'}, {'measure': 'Thermal marker of the oral mucosa : percentage of total water', 'timeFrame': 'Day 0', 'description': 'percentage of total water'}, {'measure': 'Thermal marker of the oral mucosa : maximum denaturation temperature', 'timeFrame': 'Day 0', 'description': 'maximum denaturation temperature'}, {'measure': 'Thermal marker of the oral mucosa : collagen denaturation enthalpy', 'timeFrame': 'Day 0', 'description': 'collagen denaturation enthalpy (in J/g) determined by differential calorimetric analysis'}, {'measure': 'Dielectric marker of the oral mucosa : temperature of mode 1 in the hydrated state', 'timeFrame': 'Day 0', 'description': 'temperature of mode 1 in the hydrated state'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['molecular mobility', 'collagen denaturation', 'oral mucosa', 'saliva', 'ageing'], 'conditions': ['Oral Health']}, 'referencesModule': {'references': [{'pmid': '37156074', 'type': 'RESULT', 'citation': 'Lacoste-Ferre MH, Ober C, Samouillan V. Viscoelastic behavior of oral mucosa. A rheological study using small-amplitude oscillatory shear tests. J Mech Behav Biomed Mater. 2023 Jul;143:105898. doi: 10.1016/j.jmbbm.2023.105898. Epub 2023 May 5.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this interventional with mucosa et saliva samples, monocentric, transversal and pilot study is to extract vibrational, thermal and dielectric markers obtained by Differential Scanning Calorimetry, Thermo-Stimulated Currents and Fourier Transform Infrared spectroscopy on oral mucosa and saliva samples collected from 66 patients divided in two groups (20-40 and 70-90 years old).', 'detailedDescription': 'Edentulism is prevalent in elderly people and the current care is the use of removable denture based on edentulous jaw regions. Nevertheless, the close and extended contact of denture base with mucosa and the transmission of chewing movement trough the complete denture leads to a weakening of supporting tissues in the medium to long term. This embrittlement may be accompanied by pain, compromising the proper integration of complete denture. In geriatrics, the peculiar weakness of bearing surfaces, connected to physio-pathological conditions as well as the decrease of adaptability and resistance further complicate the biomechanical integration of this kind of prosthesis. It has been shown that chronical ageing induces a decrease of resiliency and hydration of oral mucosa, associated with a decrease of epithelium thickness; nevertheless few studies have been performed at the molecular and supramolecular level to characterize this mucosa. Techniques of material characterization (Fourier transform Infrared spectroscopy, Differential scanning calorimetry (DSC), Thermostimulated currents (TSC), have shown their ability to follow hydric, molecular and structural modification of dermis upon ageing. In accordance with this study, the distribution of thermal, vibrational and dielectric markers of oral mucosa will be extracted in two age groups. The principal hypothesis of the research is the possibility to identify specific markers and to follow molecular and organizational changes induced by ageing (intrinsic ageing or extrinsic ageing due to prostheses wearing). The characterization of saliva by Fourier transform infrared spectroscopy (FTIR) shows promise in quantifying the biochemical components of this biofluid. Some vibrational saliva biomarkers have high diagnostic potential (physiological stress, diabetes, salivary lithiasis, carcinomas, periodontitis).This study is a first step to redefine the specification for the most appropriate biomaterial in removable prostheses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient requiring a classic dental surgery (extraction, implantology...) at the Toulouse University Hospital,\n* Between the ages of 20 and 40 or between 70 and 90 years\n\nExclusion Criteria:\n\n* Patient with gastrotomy probes or chemotherapy, palliative care (or with a life expectancy of less than 30 days),\n* Patient with surgical contraindication: allergy to local anesthetics, major hemorrhagic risk: patient on unbalanced Anti Vitamin K, patient on new anticoagulants not relayed or not discontinued,\n* Patient at high risk of infectious endocarditis\n* Patient under safeguard of justice.'}, 'identificationModule': {'nctId': 'NCT04178668', 'acronym': 'MMOBUCC', 'briefTitle': 'Molecular and Organizational Changes in the Human Oral Mucosa During Aging', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Toulouse'}, 'officialTitle': 'Molecular and Organizational Changes in the Human Oral Mucosa During Aging', 'orgStudyIdInfo': {'id': 'RC31/19/0423'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '20-40 years old', 'description': '33 patients between 20 and 40 years old', 'interventionNames': ['Other: Oral mucosa and saliva samples']}, {'type': 'EXPERIMENTAL', 'label': '70-90 years old', 'description': '33 patients between 70 and 90 years old', 'interventionNames': ['Other: Oral mucosa and saliva samples']}], 'interventions': [{'name': 'Oral mucosa and saliva samples', 'type': 'OTHER', 'description': 'one oral mucosa sample and one saliva sample', 'armGroupLabels': ['20-40 years old', '70-90 years old']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31059', 'city': 'Toulouse', 'country': 'France', 'facility': 'University hospital of Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'overallOfficials': [{'name': 'Marie-Hélène LACOSTE-FERRE, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital of Toulouse'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Toulouse', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Paul Sabatier of Toulouse', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}