Molecular and Organizational Changes in the Human Oral Mucosa During Aging

NCT ID: NCT04178668

Last Updated: 2023-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-11

Study Completion Date

2021-10-27

Brief Summary

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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

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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

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Oral Health

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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20-40 years old

33 patients between 20 and 40 years old

Group Type EXPERIMENTAL

Oral mucosa and saliva samples

Intervention Type OTHER

one oral mucosa sample and one saliva sample

70-90 years old

33 patients between 70 and 90 years old

Group Type EXPERIMENTAL

Oral mucosa and saliva samples

Intervention Type OTHER

one oral mucosa sample and one saliva sample

Interventions

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Oral mucosa and saliva samples

one oral mucosa sample and one saliva sample

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Paul Sabatier of Toulouse

OTHER

Sponsor Role collaborator

University Hospital, Toulouse

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marie-Hélène LACOSTE-FERRE, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Toulouse

Locations

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University hospital of Toulouse

Toulouse, , France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 37156074 (View on PubMed)

Other Identifiers

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RC31/19/0423

Identifier Type: -

Identifier Source: org_study_id

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