NCT07665489

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
12mo left

Started Sep 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 11, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 24, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

July 6, 2026

Status Verified

March 1, 2026

Enrollment Period

1 year

First QC Date

June 11, 2026

Last Update Submit

July 2, 2026

Conditions

Periodontitis, AdultPeriodontitisOral Disease

Outcome Measures

Primary Outcomes (1)

  • Value of the patient's masticatory performance

    Value of the patient's masticatory performance, obtained from the masticatory performance test (two-color chewing gum test) (quantitative variable).

    Baseline

Secondary Outcomes (7)

  • Severity of periodontal disease assessed by stage.

    Baseline (T0)

  • Pocket Depth

    Baseline

  • Gingival recessions

    Baseline

  • Bleeding on Probing (BOP)

    Baseline

  • Plaque Index

    Baseline

  • +2 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients diagnosed with periodontitis and followed at a university hospital (CHU), recruited during routine periodontal care.

You may qualify if:

  • 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.

You may not qualify if:

  • Minors.
  • Patients under legal protection (guardianship, trusteeship, or judicial protection measures).
  • Pregnant or breastfeeding women.
  • Patients who refuse to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, France

Location

MeSH Terms

Conditions

Chronic PeriodontitisPeriodontitisMouth Diseases

Condition Hierarchy (Ancestors)

Periodontal DiseasesStomatognathic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Lise Laclautre

CONTACT

0473754963promo_interne_drci@chu-clermontferrand.fr

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2026

First Posted

June 24, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

July 6, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)