Impact Evaluation of Personalized Oral Hygiene Education on Periodontal Patients Stage I/II/III

Periodontal Disease Stage I/II/III Clinical Trial

— HygParo  

Official title:

Impact Evaluation of Personalized Oral Hygiene Education on Periodontal Patients Stage I/II/III

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04745598
• Other study ID #: 8091
• Status: Not yet recruiting
• Start date: March 2021
• Est. completion date: June 2022

Study information

• Verified date: February 2021
• Source: University Hospital, Strasbourg, France
• Contact: Olivier HUCK
• Phone: +33 3 88 11 69 47
• Email: olivier.huck[@]chru-strasbourg.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Periodontal Disease Stage I/II/III
• Periodontal Diseases

Intervention

Behavioral:
• Control group: Dental Model
- Patients receive a demonstration of plaque control methods (modified Bass dental brushing technique and the use of the electric toothbrush) using a dental model.
• Computer-assisted teaching format group
- Patients receive a Powerpoint presentation containing:
• Plaque-disclosing group
- Patients place a few drops of a plaque-disclosing solution on the tongue and run the tongue over all the teeth and gums. With the aid of a hand mirror, patients can observe the stained plaque residue on their teeth
• Intra-oral camera group
- An ACTEON Soprocare® intraoral camera is used during the examination and explanation of oral hygiene strategies.

Locations

Country	Name	City	State
France	Les Hôpitaux Universitaires de Strasbourg	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

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