Periodontal Disease Stage I/II/III Clinical Trial
— HygParoOfficial title:
Impact Evaluation of Personalized Oral Hygiene Education on Periodontal Patients Stage I/II/III
| NCT number | NCT04745598 |
| Other study ID # | 8091 |
| Secondary ID | |
| Status | Not yet recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | March 2021 |
| Est. completion date | June 2022 |
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.
| Status | Not yet recruiting |
| Enrollment | 120 |
| Est. completion date | June 2022 |
| Est. primary completion date | March 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Les Hôpitaux Universitaires de Strasbourg | Strasbourg |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Strasbourg, France |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Evaluation of the plaque index | Plaque Index (Loë and Silness, 1963): Six surfaces per tooth (buccal, mesio-buccal, disto-buccal, lingual, mesio-lingual and disto-lingual) are examined in every permanent tooth (except for third molars).
Each tooth is assessed with a score between 0 and 3. 0 : absence of dental plaque 1 : plaque disclosed after running the periodontal probe along the gingival margin 2: visible plaque; absence of plaque in the interdental spaces 3: abundant plaque; presence of plaque in the interdental spaces |
3 months | |
| Primary | Evaluation of the gingival index | Gingival Index (Loë 1967):
Six surfaces per tooth (buccal, mesio-buccal, disto-buccal, lingual, mesio-lingual and disto-lingual) are examined in every permanent tooth (except for third molars). 0: absence of visual signs of inflammation 1 : slight change in color and texture o 2: Visual inflammation and bleeding tendency from the gingival margin right after a periodontal probe is briefly run along the gingival margin 3: Overt inflammation with tendency for spontaneous bleeding |
3 months | |
| Secondary | Evaluation of probing pocket depth | Probing pocket depth (distance from the top of the marginal gingiva to the bottom of the pocket) | 3 months | |
| Secondary | Evaluation of the gingival attachment level | Gingival attachment level (distance separating the cemento-enamel junction from the bottom of the pocket) | 3 months | |
| Secondary | Psychological determinants of the HAPA (Health Action Process Approach) | Change in the psychological determinants of the HAPA questionnaire adapted to oral health, using a 7-point Likert scale from "strongly disagree" (1) to "strongly agree" (7) | 3 months |