Oral HealthMMOBUCCNCT04178668
Molecular and Organizational Changes in the Human Oral Mucosa During Aging
A study testing Oral mucosa and saliva samples in people with Oral Health, run by University Hospital, Toulouse at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Oral Health
- What is being tested?
- Oral mucosa and saliva samples
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteFrance
- Study dates
- 11 Mar 2020to 27 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the 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.
- Conditions
- Oral Health
- Being tested
- Oral mucosa and saliva samples
- Keywords
- molecular mobility, collagen denaturation, oral mucosa, saliva, ageing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral mucosa and saliva samplesOther
one oral mucosa sample and one saliva sample
| Study group | Role | What they receive |
|---|---|---|
| 20-40 years old | Experimental | 33 patients between 20 and 40 years old Receives: Other: Oral mucosa and saliva samples |
| 70-90 years old | Experimental | 33 patients between 70 and 90 years old Receives: Other: Oral mucosa and saliva samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vibrational marker of the oral mucosa: collagen 1 fraction indicator
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
Measured: Day 0
Vibrational marker of the oral mucosa : collagen 2 fraction indicator
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
Measured: Day 0
Thermal marker of the oral mucosa : percentage of open water
percentage of open water
Measured: Day 0
Thermal marker of the oral mucosa: percentage of water related
percentage of water related
Measured: Day 0
Thermal marker of the oral mucosa : percentage of total water
percentage of total water
Measured: Day 0
Thermal marker of the oral mucosa : maximum denaturation temperature
maximum denaturation temperature
Measured: Day 0
Thermal marker of the oral mucosa : collagen denaturation enthalpy
collagen denaturation enthalpy (in J/g) determined by differential calorimetric analysis
Measured: Day 0
Dielectric marker of the oral mucosa : temperature of mode 1 in the hydrated state
temperature of mode 1 in the hydrated state
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2019
- Study start11 Mar 2020
- Primary completion27 Oct 2021
- Study completion27 Oct 2021
Why it stopped: Difficulty in recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Oral HealthStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Collaborators
- University Paul Sabatier of Toulouse
- Responsible party
- Sponsor
- Investigators
- Marie-Hélène LACOSTE-FERRE, MD, Principal investigator, University Hospital of Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04178668
- Sponsor's protocol ID
- RC31/19/0423
- Acronym
- MMOBUCC
- Status last verified
- May 2023
- First submitted
- 13 Nov 2019
- Last updated
- 25 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37156074Samouillan V, Ober C, Lacoste-Ferre MH. Impact of Aging and Pathologies on Human Oral Mucosa: Preliminary Investigation of Biophysical Markers from Thermal and Vibrational Analyses. Biomolecules. 2025 Jul 8;15(7):978. doi: 10.3390/biom15070978.
PubMed 40723850
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular and Organizational Changes in the Human Oral Mucosa During Aging
- ClinicalTrials.gov ID
- NCT04178668
- Acronym / sponsor ID
- MMOBUCC / RC31/19/0423
- Conditions
- Oral Health
- Keywords
- molecular mobility, collagen denaturation, oral mucosa, saliva, ageing
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty in recruitment
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Collaborators
- University Paul Sabatier of Toulouse
- Study start
- 11 Mar 2020 (actual)
- Primary completion
- 27 Oct 2021 (actual)
- Study completion
- 27 Oct 2021 (actual)
- First posted
- 26 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 20-40 years old | Experimental | Other: Oral mucosa and saliva samples33 patients between 20 and 40 years old |
| 70-90 years old | Experimental | Other: Oral mucosa and saliva samples33 patients between 70 and 90 years old |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral mucosa and saliva samplesone oral mucosa sample and one saliva sample | Other | 20-40 years old, 70-90 years old |
Primary outcome
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
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
Thermal marker of the oral mucosa : percentage of open water
Time frame: Day 0
percentage of open water
Thermal marker of the oral mucosa: percentage of water related
Time frame: Day 0
percentage of water related
Thermal marker of the oral mucosa : percentage of total water
Time frame: Day 0
percentage of total water
Thermal marker of the oral mucosa : maximum denaturation temperature
Time frame: Day 0
maximum denaturation temperature
Thermal marker of the oral mucosa : collagen denaturation enthalpy
Time frame: Day 0
collagen denaturation enthalpy (in J/g) determined by differential calorimetric analysis
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
Results and safety
The study was stopped early (reason given: Difficulty in recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2023.
- Results publication: PubMed 37156074Lacoste-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.
- Derived from this study: PubMed 40723850Samouillan V, Ober C, Lacoste-Ferre MH. Impact of Aging and Pathologies on Human Oral Mucosa: Preliminary Investigation of Biophysical Markers from Thermal and Vibrational Analyses. Biomolecules. 2025 Jul 8;15(7):978. doi: 10.3390/biom15070978.
- Individual participant dataSharing planned: No
Related trials for Oral Health
Active, not recruiting
Alveolar Ridge Reconstruction in Post-extraction Sites Using a Magnesium Resorbable Membrane. An Explorative Study
Bone Augmentation, Alveolar Ridge Augmentation
RecruitingPhase 4
Oral Azacitidine in Transplant-Eligible Patients With Acute Myeloid Leukemia (AML) Suffering From Health-Inequality
Acute Myeloid Leukemia
Not yet recruiting
Game-based Oral Health Promotion
Oral Hygiene
Not yet recruiting
Manus AI-Assisted Orthodontic Education and Oral Health-Related Quality of Life
Oral Health-Related Quality of Life
Recruiting
CBCT vs OPT on the Oral Health Status at 12 Months of Patients Hospitalized for Infective Endocarditis.
Infective Endocarditis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie-Hélène LACOSTE-FERRE, MD principal investigator
University Hospital of Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral mucosa and saliva samples in people with Oral Health, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Difficulty in recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vibrational marker of the oral mucosa: collagen 1 fraction indicator (time frame: Day 0). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04178668, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2023.