NCT07651579

Brief Summary

The objective of this single-center prospective study is to evaluate the impact of periodontal treatment on masticatory performance in patients with periodontitis. Participants will be asked to complete several questionnaires related to their oral health and quality of life. Functional masticatory tests and salivary flow measurements will also be performed.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
24mo left

Started Sep 2026

Typical duration for not_applicable

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 1, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 16, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2028

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2028

Last Updated

July 6, 2026

Status Verified

March 1, 2026

Enrollment Period

2 years

First QC Date

June 1, 2026

Last Update Submit

July 2, 2026

Conditions

PeriodontitisPeriodontal DiseasesQuality of Life

Outcome Measures

Primary Outcomes (1)

  • The patient's masticatory performance score

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

    Baseline (T0), T1 (T0 + 3 month), T2 (end of treatment if complementary treatments are required, assessed no later than 1 year after the start of the initial treatment)

Secondary Outcomes (12)

  • Severity of periodontal disease assessed by stage.

    Baseline (T0), T1 (T0 + 3 month), T2 (end of treatment if complementary treatments are required, assessed no later than 1 year after the start of the initial treatment)

  • Salivation

    Baseline (T0), T1 (T0 + 3 month), T2 (end of treatment if complementary treatments are required, assessed no later than 1 year after the start of the initial treatment)

  • Swallowing

    Baseline (T0), T1 (T0 + 3 month), T2 (end of treatment if complementary treatments are required, assessed no later than 1 year after the start of the initial treatment)

  • Periodontitis grade (Chicago Classification)

    Baseline (T0), T1 (T0 + 3 month), T2 (end of treatment if complementary treatments are required, assessed no later than 1 year after the start of the initial treatment)

  • Gingival recessions

    Baseline (T0), T1 (T0 + 3 month), T2 (end of treatment if complementary treatments are required, assessed no later than 1 year after the start of the initial treatment)

  • +7 more secondary outcomes

Study Arms (1)

Periodontisis

EXPERIMENTAL

Patients diagnosed with periodontitis will receive standard non-surgical periodontal treatment as part of routine care. Clinical and functional assessments will be performed at baseline (T0) and during follow-up visits (T1, T2) to evaluate changes in masticatory performance, salivary flow, and oral health-related quality of life.

Other: Functionnal test

Interventions

Functionnal testOTHER

Administration of questionnaires, functional masticatory test, and saliva collection.

Periodontisis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients treated at the university hospital and diagnosed with periodontitis
  • Adult patients who have provided informed consent
  • Patients enrolled in a social security system
  • Patients who speak and understand French.

You may not qualify if:

  • Minors
  • Pregnant or breastfeeding patients
  • Patients under legal protection or conservatorship
  • 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

PeriodontitisPeriodontal Diseases

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Central Study Contacts

Lise Laclautre

CONTACT

0473754963promo_interne_drci@chu-clermontferrand.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2026

First Posted

June 16, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

September 1, 2028

Last Updated

July 6, 2026

Record last verified: 2026-03

Locations

FR(1)