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Periodontitis, AdultPAROQoLNCT07868042

Evaluation of Changes in Oral Health-related Quality of Life During the Treatment of Periodontitis.

An observational study of Periodontitis, Adult and Periodontitis, run by University Hospital, Clermont-Ferrand at 1 site in France.

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Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

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Trial summary

Periodontitis is a chronic inflammatory disease affecting the supporting tissues of the teeth and may negatively affect patients' oral health-related quality of life. Although periodontal treatment is expected to improve periodontal health, its impact on patients' perceived oral quality of life has been less… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Periodontitis, Adult, Periodontitis, Oral Disease
How many people
100 participants
Where
1 siteFrance
Study dates
1 Oct 2026to 1 Sep 2028
Phase
Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: The study population will consist of approximately 100 adult patients with periodontitis requiring non-surgical and/or surgical periodontal treatment in the Department of Odontology at Clermont-Ferrand University Hospital. Participants will be French-speaking and able to understand and complete the oral health-related quality of life questionnaires used in the study. Patients will be followed prospectively throughout their periodontal treatment and subsequent reassessment visits.

Who may be able to join

  • Patient requiring non-surgical and/or surgical periodontal treatment in the Periodontology Department, Department of Odontology.
  • Patient willing to participate in the study and not opposed to participation.
  • Patient able to understand and speak French.

Who cannot join

  • Patient under 18 years of age.
  • Patient with cognitive impairment.
  • Patient without health insurance coverage.
  • Patient under guardianship, curatorship, or judicial safeguard.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Lise Laclautre contact

0473754963

promo_interne_drci@chu-clermontferrand.fr

France1 site

  • CHU de Clermont-Ferrand

    Clermont-Ferrand

    Lise Laclautre, 0473754963, promo_interne_drci@chu-clermontferrand.fr

    Anne COUDERT

Other trials in France

About this study

Official title: Evaluation of Changes in Oral Health-related Quality of Life During the Treatment of Periodontitis

Periodontitis is a chronic inflammatory disease affecting the supporting tissues of the teeth and may negatively affect patients' oral health-related quality of life. Although periodontal treatment is expected to improve periodontal health, its impact on patients' perceived oral quality of life has been less extensively studied.

The PAROQoL CROC study is a prospective and monocentric study designed to evaluate changes in oral health-related quality of life in patients with periodontitis undergoing periodontal treatment. Oral quality of life will be assessed using two validated questionnaires, the OHIP-14 and the GOHAI, before treatment and during follow-up.

Read more

Clinical periodontal parameters, including probing pocket depth, bleeding on probing, plaque levels and clinical attachment loss, will also be collected. The study will investigate the relationship between changes in oral quality of life and clinical periodontal outcomes, as well as the potential influence of patient characteristics and oral hygiene habits.

A total of 100 adult patients with periodontitis requiring periodontal treatment will be included.

Read the detailed description

The PAROQoL CROC study is a prospective, monocentric study conducted in the Department of Odontology of Clermont-Ferrand University Hospital, France. The study will include 100 adult patients diagnosed with periodontitis who require non-surgical and/or surgical periodontal treatment.

At baseline (T0), participants will complete two self-administered questionnaires assessing oral health-related quality of life: the OHIP-14 and the GOHAI. Periodontal clinical data routinely collected as part of patient care will also be recorded. These include probing pocket depth, bleeding on probing, plaque levels and clinical attachment loss.

Participants will subsequently complete the same quality-of-life questionnaires at four follow-up assessments. The first reassessment (T1) will take place approximately 6 to 8 weeks after the initial periodontal treatment. A second reassessment (T2) will take place approximately 6 to 8 weeks later. Depending on the clinical response, further periodontal treatment, including additional non-surgical treatment or periodontal surgery, may be performed as part of routine care.

A third reassessment (T3) will take place approximately 3 months after the preceding treatment phase, and a final assessment (T4) will take place approximately 3 months later. The timing of the follow-up assessments will therefore take into account the periodontal treatment pathway of each participant.

Medical subject headings
Chronic Periodontitis, Periodontitis, Mouth Diseases

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in OHIP-14 score

    Change in OHIP-14 score from before periodontal scaling to the periodontal disease reassessment visit approximately 6-8 weeks later, corresponding to the time required for gingival healing.

    Measured: Baseline (T0, before treatment); 6-8 weeks after T0 (T1); 6-8 weeks after T1 (T2); 3 months after T2 (T3); 3 months after T3 (T4).

Secondary outcomes (12)

  1. Change in mean probing pocket depth

    Change in mean probing pocket depth (mm) between baseline (T0) and the first reassessment visit (T1).

    Measured: From baseline (T0) to the first reassessment visit (T1), approximately 6-8 weeks after initial periodontal treatment.

  2. Change in mean clinical attachment loss

    Change in mean clinical attachment loss (mm) between baseline (T0) and the first reassessment visit (T1).

    Measured: From baseline (T0) to the first reassessment visit (T1), approximately 6-8 weeks after initial periodontal treatment.

  3. Change in mean plaque percentage

    Change in mean plaque percentage (%) between baseline (T0) and the first reassessment visit (T1).

    Measured: From baseline (T0) to the first reassessment visit (T1), approximately 6-8 weeks after initial periodontal treatment.

  4. Change in mean bleeding on probing percentage

    Change in mean bleeding on probing percentage (%) between baseline (T0) and the first reassessment visit (T1).

    Measured: From baseline (T0) to the first reassessment visit (T1), approximately 6-8 weeks after initial periodontal treatment.

  5. Change in number of functional units

    Change in the number of functional units between baseline (T0) and the first reassessment visit (T1).

    Measured: From baseline (T0) to the first reassessment visit (T1), approximately 6-8 weeks after initial periodontal treatment.

  6. Correlation between periodontal parameters and patient characteristics, oral hygiene habits, and quality-of-life scores

    Correlation between mean probing pocket depth (mm), mean clinical attachment loss (mm), mean plaque percentage (%), and mean bleeding on probing percentage (%) and diabetes status, age (years), smoking status, twice-daily tooth brushing (yes/no), interdental brush use (yes/no), and changes in GOHAI and OHIP-14 scores.

    Measured: Baseline (T0, before treatment); 6-8 weeks after T0 (T1); 6-8 weeks after T1 (T2); 3 months after T2 (T3); 3 months after T3 (T4).

  7. Patient costs associated with periodontal treatment.

    Assessment of direct medical costs from the hospital perspective, including the cost of periodontal procedures and radiological examinations, as well as costs related to the management of patients with diabetes when applicable. Patient-related costs will include transportation costs and out-of-pocket expenses after reimbursement by complementary health insurance at each assessment time point.

    Measured: Baseline (T0, before treatment); 6-8 weeks after T0 (T1); 6-8 weeks after T1 (T2); 3 months after T2 (T3); 3 months after T3 (T4).

  8. Correlation between changes in oral health-related quality of life and changes in probing pocket depth

    Correlation between changes in OHIP-14 and GOHAI scores and changes in mean probing pocket depth (mm).

    Measured: Baseline (T0, before treatment); 6-8 weeks after T0 (T1); 6-8 weeks after T1 (T2); 3 months after T2 (T3); 3 months after T3 (T4).

  9. Correlation between changes in oral health-related quality of life and changes in clinical attachment loss

    Correlation between changes in OHIP-14 and GOHAI scores and changes in mean clinical attachment loss (mm).

    Measured: Baseline (T0, before treatment); 6-8 weeks after T0 (T1); 6-8 weeks after T1 (T2); 3 months after T2 (T3); 3 months after T3 (T4).

  10. Correlation between changes in oral health-related quality of life and changes in plaque percentage

    Correlation between changes in OHIP-14 and GOHAI scores and changes in mean plaque percentage (%).

    Measured: Baseline (T0, before treatment); 6-8 weeks after T0 (T1); 6-8 weeks after T1 (T2); 3 months after T2 (T3); 3 months after T3 (T4).

  11. Correlation between changes in oral health-related quality of life and changes in bleeding on probing percentage

    Correlation between changes in OHIP-14 and GOHAI scores and changes in mean bleeding on probing percentage (%).

    Measured: Baseline (T0, before treatment); 6-8 weeks after T0 (T1); 6-8 weeks after T1 (T2); 3 months after T2 (T3); 3 months after T3 (T4).

  12. Correlation between changes in oral health-related quality of life and changes in number of functional units

    Correlation between changes in OHIP-14 and GOHAI scores and changes in the number of functional units (number).

    Measured: Baseline (T0, before treatment); 6-8 weeks after T0 (T1); 6-8 weeks after T1 (T2); 3 months after T2 (T3); 3 months after T3 (T4).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Oct 2026
  2. Study start1 Oct 2026 (estimated)
  3. Primary completion1 Sep 2027 (estimated)
  4. Study completion1 Sep 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07868042
Sponsor's protocol ID
RNI 2026 COUDERT (PAROQoLCROC)
Other IDs
2026-A00727-44
Acronym
PAROQoL
Status last verified
Aug 2026
First submitted
14 Sep 2026
Last updated
9 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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