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

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.

Study Overview

• Status: Unknown
• Conditions: Periodontal Disease Stage I/II/III
• Intervention / Treatment: Behavioral: Control group: Dental Model; Behavioral: Computer-assisted teaching format group; Behavioral: Plaque-disclosing group; Behavioral: Intra-oral camera group

• Study Type: Observational
• Enrollment (Anticipated): 120

Contacts and Locations

Study Locations

• France
  • Strasbourg, France, 67091
    • Les Hôpitaux Universitaires de Strasbourg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Periodontal patients in maintenance phase treated at the Periodontics Department of the Civil Hospital of Strasbourg

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control group: Dental model; Patients diagnosed with periodontal disease stage I/II/III	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 diagnosed with periodontal disease stage I/II/III	Behavioral: Computer-assisted teaching format group; - Patients receive a Powerpoint presentation containing:
Plaque-disclosing group; Patients diagnosed with periodontal disease stage I/II/III	Behavioral: 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; Patients diagnosed with periodontal disease stage I/II/III	Behavioral: Intra-oral camera group; - An ACTEON Soprocare® intraoral camera is used during the examination and explanation of oral hygiene strategies.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of probing pocket depth	Probing pocket depth (distance from the top of the marginal gingiva to the bottom of the pocket)	3 months
Evaluation of the gingival attachment level	Gingival attachment level (distance separating the cemento-enamel junction from the bottom of the pocket)	3 months
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

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2021
• Primary Completion (Anticipated): March 1, 2021
• Study Completion (Anticipated): June 1, 2022

Study Registration Dates

• First Submitted: February 4, 2021
• First Submitted That Met QC Criteria: February 4, 2021
• First Posted (Actual): February 9, 2021

Study Record Updates

• Last Update Posted (Actual): February 9, 2021
• Last Update Submitted That Met QC Criteria: February 4, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Periodontal Diseases
• Other Study ID Numbers: 8091

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No