- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04178668
Molecular and Organizational Changes in the Human Oral Mucosa During Aging (MMOBUCC)
May 23, 2023 updated by: University Hospital, Toulouse
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).
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
38
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Toulouse, France, 31059
- University Hospital of Toulouse
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patient requiring a classic dental surgery (extraction, implantology...) at the Toulouse University Hospital,
- Between the ages of 20 and 40 or between 70 and 90 years
Exclusion Criteria:
- Patient with gastrotomy probes or chemotherapy, palliative care (or with a life expectancy of less than 30 days),
- 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,
- Patient at high risk of infectious endocarditis
- Patient under safeguard of justice.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 20-40 years old
33 patients between 20 and 40 years old
|
one oral mucosa sample and one saliva sample
|
Experimental: 70-90 years old
33 patients between 70 and 90 years old
|
one oral mucosa sample and one saliva sample
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Vibrational marker of the oral mucosa: collagen 1 fraction indicator
Time Frame: Day 0
|
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
|
Day 0
|
Vibrational marker of the oral mucosa : collagen 2 fraction indicator
Time Frame: Day 0
|
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
|
Day 0
|
Thermal marker of the oral mucosa : percentage of open water
Time Frame: Day 0
|
percentage of open water
|
Day 0
|
Thermal marker of the oral mucosa: percentage of water related
Time Frame: Day 0
|
percentage of water related
|
Day 0
|
Thermal marker of the oral mucosa : percentage of total water
Time Frame: Day 0
|
percentage of total water
|
Day 0
|
Thermal marker of the oral mucosa : maximum denaturation temperature
Time Frame: Day 0
|
maximum denaturation temperature
|
Day 0
|
Thermal marker of the oral mucosa : collagen denaturation enthalpy
Time Frame: Day 0
|
collagen denaturation enthalpy (in J/g) determined by differential calorimetric analysis
|
Day 0
|
Dielectric marker of the oral mucosa : temperature of mode 1 in the hydrated state
Time Frame: Day 0
|
temperature of mode 1 in the hydrated state
|
Day 0
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Marie-Hélène LACOSTE-FERRE, MD, University Hospital of Toulouse
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 11, 2020
Primary Completion (Actual)
October 27, 2021
Study Completion (Actual)
October 27, 2021
Study Registration Dates
First Submitted
November 13, 2019
First Submitted That Met QC Criteria
November 25, 2019
First Posted (Actual)
November 26, 2019
Study Record Updates
Last Update Posted (Actual)
May 25, 2023
Last Update Submitted That Met QC Criteria
May 23, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- RC31/19/0423
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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