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Not yet recruitingNCT07868042PAROQoLUpdated Oct 9, 2026

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

An observational study in Periodontitis, Adult, Periodontitis and Oral Disease, sponsored by University Hospital, Clermont-Ferrand. Not yet recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-09.

Sponsored by University Hospital, Clermont-Ferrand · Observational

Updated Oct 9, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
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Study 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 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.

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.

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Conditions studied

  • Periodontitis, Adult
  • Periodontitis
  • Oral Disease
  • Quality of Life
03

In context

Chronic Periodontitis

386 studies on the registry are indexed under Chronic Periodontitis; 23 are open to participants now.

This study's planned enrollment of 100 is above the median of 75 across 67 observational studies indexed under Chronic Periodontitis.

Browse Chronic Periodontitis studies →

Lead sponsor

University Hospital, Clermont-Ferrand is the lead sponsor of 854 studies on the registry; 180 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

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

Observational model
Other
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No
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What researchers measure

Primary outcomes

  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.

    Time frame: 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

  1. Change in mean probing pocket depth

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

    Time frame: 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).

    Time frame: 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).

    Time frame: 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).

    Time frame: 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).

    Time frame: 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.

    Time frame: 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.

    Time frame: 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).

    Time frame: 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).

    Time frame: 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 (%).

    Time frame: 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 (%).

    Time frame: 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).

    Time frame: 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).

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Study locations

1 site
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 9, 2026
Show all 1 update
  1. Oct 9, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

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Registry details

Key details

Study ID
NCT07868042
Responsible party
Sponsor
First posted
Oct 9, 2026
Start date
Oct 1, 2026 (estimated)
Primary completion
Sep 1, 2027 (estimated)
Completion
Sep 1, 2028 (estimated)
Last update
Oct 9, 2026

Study contacts

Lise Laclautre
Contact
promo_interne_drci@chu-clermontferrand.fr
0473754963
Anne COUDERT
principal investigator · University Hospital, Clermont-Ferrand

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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