NCT04178668

Brief 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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 13, 2019

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 26, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

March 11, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 27, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 27, 2021

Completed
Last Updated

May 25, 2023

Status Verified

May 1, 2023

Enrollment Period

1.6 years

First QC Date

November 13, 2019

Last Update Submit

May 23, 2023

Conditions

Oral Health

Keywords

molecular mobilitycollagen denaturationoral mucosasalivaageing

Outcome Measures

Primary Outcomes (8)

  • 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

Study Arms (2)

20-40 years old

EXPERIMENTAL

33 patients between 20 and 40 years old

Other: Oral mucosa and saliva samples

70-90 years old

EXPERIMENTAL

33 patients between 70 and 90 years old

Other: Oral mucosa and saliva samples

Interventions

Oral mucosa and saliva samplesOTHER

one oral mucosa sample and one saliva sample

20-40 years old70-90 years old

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University hospital of Toulouse

Toulouse, 31059, France

Location

Related 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 Jul;143:105898. doi: 10.1016/j.jmbbm.2023.105898. Epub 2023 May 5.

    PMID: 37156074RESULT

MeSH Terms

Interventions

Endomet

Study Officials

  • Marie-Hélène LACOSTE-FERRE, MD

    University Hospital of Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2019

First Posted

November 26, 2019

Study Start

March 11, 2020

Primary Completion

October 27, 2021

Study Completion

October 27, 2021

Last Updated

May 25, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)