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

NCT07868042 | Not Yet Recruiting

• 2 other identifiers: RNI 2026 COUDERT (PAROQoLCROC)2026-A00727-44
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Periodontitis, Adult; Periodontitis; Oral Disease; Quality of Life

Outcome Measures

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.

  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)

• Change in mean probing pocket depth

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

• Change in mean clinical attachment loss

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

• Change in mean plaque percentage

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

• Change in mean bleeding on probing percentage

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

• Change in number of functional units

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, France

Location

MeSH Terms

Conditions

Chronic Periodontitis; Periodontitis; Mouth Diseases

Condition Hierarchy (Ancestors)

Periodontal Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Anne COUDERT

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise Laclautre

CONTACT

0473754963; promo_interne_drci@chu-clermontferrand.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2026
• First Posted: October 9, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2028
• Last Updated: October 9, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)