Molecular and Organizational Changes in the Human Oral Mucosa During Aging (MMOBUCC)

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: Oral Health
• Intervention / Treatment: Other: Oral mucosa and saliva samples

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

Study Locations

• France
  • Toulouse, France, 31059
    • University Hospital of Toulouse

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 20-40 years old; 33 patients between 20 and 40 years old	Other: Oral mucosa and saliva samples; one oral mucosa sample and one saliva sample
Experimental: 70-90 years old; 33 patients between 70 and 90 years old	Other: Oral mucosa and saliva samples; 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	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	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	percentage of open water	Day 0
Thermal marker of the oral mucosa: percentage of water related	percentage of water related	Day 0
Thermal marker of the oral mucosa : percentage of total water	percentage of total water	Day 0
Thermal marker of the oral mucosa : maximum denaturation temperature	maximum denaturation temperature	Day 0
Thermal marker of the oral mucosa : collagen denaturation enthalpy	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	temperature of mode 1 in the hydrated state	Day 0

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Collaborators: University Paul Sabatier of Toulouse
• Investigators: Principal Investigator: Marie-Hélène LACOSTE-FERRE, MD, University Hospital of Toulouse

Publications and helpful links

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

Study record dates

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

• Keywords: ageing; saliva; oral mucosa; molecular mobility; collagen denaturation
• 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