Clinical trial NCT04745598: Impact Evaluation of Personalized Oral Hygiene Education on Periodontal Patients Stage I/II/III
Official title: Impact Evaluation of Personalized Oral Hygiene Education on Periodontal Patients Stage I/II/III
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Periodontal Disease Stage I/II/III
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2021-02-09
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Periodontal patients in maintenance phase treated at the Periodontics Department of the Civil Hospital of Strasbourg

Brief summary: Evaluation of personalized oral hygiene education on plaque accumulation and gingival inflammation in periodontal patients stage I/II/III.

Evaluation of personalized oral hygiene education on clinical attachment level in periodontal patients stage I/II/III.

Evaluation of personalized oral hygiene education on the psychological determinants described by the Health Action Process Approach (HAPA) and the mediating role of these psychological determinants in oral hygiene habits and clinical parameters in periodontal patients stage I/II/III.


Eligibility criteria: Inclusion criteria:

* ≥ 18 years old
* Subject having signed an informed consent
* Subjects with periodontal disease Stage I/II/III :
* ≥ 15 teeth/implants
* Bleeding index at ≥ 25%
* Plaque index ≥ 20%
* Not requiring antibiotic prophylaxis prior to periodontal treatment.
* Not having received surgical periodontal treatment in the last 12 months.
* Smokers of ≤10 cigarettes/day

Exclusion criteria:

* \<15 teeth/implants
* Physical or mental disability that does not allow for the performance of oral hygiene procedures.
* Chronic progressive pathology (diabetes...) / immunodeficiencies (HIV...)/ systemic infections.
* Ongoing drug treatment leading to a significant change in the periodontal condition (anti-epileptics, calcium antagonists, immunosuppressants, hormonal treatments, etc.).
* Ongoing drug treatment that can influence the periodontal condition (anti-inflammatory drugs, antibiotics)
* Patients with severe xerostomia or with Gougerot-Sjögren's syndrome.
* Subjects undergoing treatment for cancer
* Pregnant or breastfeeding women
* Smokers of \> 10 cigarettes/day
* Impossibility to give information about the subject (subject in an emergency situation, difficulties in understanding the French language, etc.).
* Subject under safeguard of justice
* Subject under guardianship or curatorship

Primary outcomes:
measure: Evaluation of the plaque index
timeFrame: 3 months
measure: Evaluation of the gingival index
timeFrame: 3 months
Secondary outcomes:
measure: Evaluation of probing pocket depth
timeFrame: 3 months
measure: Evaluation of the gingival attachment level
timeFrame: 3 months
measure: Psychological determinants of the HAPA (Health Action Process Approach)
timeFrame: 3 months
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Les Hôpitaux Universitaires de Strasbourg
Study officials:
References: