Molecular and Organizational Changes in the Human Oral Mucosa During Aging

Oral Health Clinical Trial

— MMOBUCC  

Official title:

Molecular and Organizational Changes in the Human Oral Mucosa During Aging

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04178668
• Other study ID #: RC31/19/0423
• Status: Terminated
• Phase: N/A
• Start date: March 11, 2020
• Est. completion date: October 27, 2021

Study information

• Verified date: May 2023
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 collected from 66 patients divided in two groups (20-40 and 70-90 years old).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 38
• Est. completion date: October 27, 2021
• Est. primary completion date: October 27, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Oral Health

Intervention

Other:
• Oral mucosa and saliva samples
one oral mucosa sample and one saliva sample

Locations

Country	Name	City	State
France	University hospital of Toulouse	Toulouse

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Toulouse	University Paul Sabatier of Toulouse

Country where clinical trial is conducted

France, 

References & Publications (1)

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 May 5;143:105898. doi: 10.1016/j.jmbbm.2023.105898. Online ahead of print. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Day 0
Primary	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	Day 0
Primary	Thermal marker of the oral mucosa : percentage of open water	percentage of open water	Day 0
Primary	Thermal marker of the oral mucosa: percentage of water related	percentage of water related	Day 0
Primary	Thermal marker of the oral mucosa : percentage of total water	percentage of total water	Day 0
Primary	Thermal marker of the oral mucosa : maximum denaturation temperature	maximum denaturation temperature	Day 0
Primary	Thermal marker of the oral mucosa : collagen denaturation enthalpy	collagen denaturation enthalpy (in J/g) determined by differential calorimetric analysis	Day 0
Primary	Dielectric marker of the oral mucosa : temperature of mode 1 in the hydrated state	temperature of mode 1 in the hydrated state	Day 0