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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
38

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • France
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Toulouse

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University Paul Sabatier of Toulouse

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 11, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 27, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 27, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 13, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 25, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 26, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 25, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 23, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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