Evaluation of Changes in Oral Health-related Quality of Life During the Treatment of Periodontitis.
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Clermont-Ferrand
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Patient under 18 years of age.
Patient with cognitive impairment.
Patient without health insurance coverage.
Patient under guardianship, curatorship, or judicial safeguard.
Trial 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.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
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.Sponsors and contacts
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Source ClinicalTrials.gov
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