- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07665489
Evaluation of Masticatory Performance in Patients With Periodontitis (PAROCHEW)
The objective of this observational study is to assess the correlation between the severity of periodontal involvement and masticatory performance in patients with periodontitis.
The secondary objectives are to identify periodontal parameters that may be associated with a reduction in masticatory performance.
This study includes a single group.
Participants will be asked to perform a masticatory performance test consisting of chewing a piece of gum for 20 cycles.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Lise Laclautre
- Phone Number: 0473754963
- Email: promo_interne_drci@chu-clermontferrand.fr
Study Locations
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-
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Clermont-Ferrand, France
- CHU clermont-ferrand
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Contact:
- Lise Laclautre
- Phone Number: 0473754963
- Email: promo_interne_drci@chu-clermontferrand.fr
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Principal Investigator:
- Thomas DOUILLARD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients followed at the university hospital (CHU) with a diagnosis of periodontitis.
- No objection from the patient to participate in the study.
- Patients able to speak and understand French.
Exclusion Criteria:
- Minors.
- Patients under legal protection (guardianship, trusteeship, or judicial protection measures).
- Pregnant or breastfeeding women.
- Patients who refuse to participate in the study.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Value of the patient's masticatory performance
Time Frame: Baseline
|
Value of the patient's masticatory performance, obtained from the masticatory performance test (two-color chewing gum test) (quantitative variable).
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pocket Depth
Time Frame: Baseline
|
Periodontal probing depth.
Unit of Measure: Millimeters (mm)
|
Baseline
|
|
Gingival recessions
Time Frame: Baseline
|
Measurement of gingival recession depth.
Unit of Measure : Millimeters (mm)
|
Baseline
|
|
Bleeding on Probing (BOP)
Time Frame: Baseline
|
Percentage (%) of sites showing bleeding on probing.
|
Baseline
|
|
Plaque Index
Time Frame: Baseline
|
Plaque accumulation assessed using a validated plaque index (specify full name of index).
|
Baseline
|
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Tooth Mobility
Time Frame: Baseline
|
Tooth mobility assessed using the Miller classification (Grade 0-3).
Higher scores indicate greater mobility and worse periodontal condition.
Unit of Measure: Millimeters (mm)
|
Baseline
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Edentulism
Time Frame: Baseline
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Presence or absence of edentulism.
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Baseline
|
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Severity of periodontal disease assessed by stage.
Time Frame: Baseline (T0)
|
Stage of periodontitis according to the Chicago classification.
Categorical (Stage 1 (early-stage periodontitis) to Stage 4 (severe periodontitis) as defined by classification)
|
Baseline (T0)
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RNI 2026 DOUILLARD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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