Periodontal Disease Stage I/II/IIIHygParoNCT04745598
Impact Evaluation of Personalized Oral Hygiene Education on Periodontal Patients Stage I/II/III
An observational study of Periodontal Disease Stage I/II/III, run by University Hospital, Strasbourg, France at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periodontal Disease Stage I/II/III
- What is being tested?
- Computer-assisted teaching format group, Plaque-disclosing group and Intra-oral camera group
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2021to Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Periodontal patients in maintenance phase treated at the Periodontics Department of the Civil Hospital of Strasbourg
Who may be able to join
- ≥ 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%
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- Not requiring antibiotic prophylaxis prior to periodontal treatment.
- Not having received surgical periodontal treatment in the last 12 months.
- Smokers of ≤10 cigarettes/day
Who cannot join
- <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.
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- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Les Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
Olivier HUCK, +33 3 88 11 69 47, olivier.huck@chru-strasbourg.fr
Olivier HUCK
About this study
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.
- Conditions
- Periodontal Disease Stage I/II/III
- Being tested
- Control group: Dental Model, Computer-assisted teaching format group, Plaque-disclosing group, Intra-oral camera group
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control group: Dental ModelBehavioural
- 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 groupBehavioural
- Patients receive a Powerpoint presentation containing:
Plaque-disclosing groupBehavioural
- 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 groupBehavioural
- An ACTEON Soprocare® intraoral camera is used during the examination and explanation of oral hygiene strategies.
| Study group | Role | What they receive |
|---|---|---|
| Control group: Dental model | Patients diagnosed with periodontal disease stage I/II/III Receives: Behavioral: Control group: Dental Model | |
| Computer-assisted teaching format group | Patients diagnosed with periodontal disease stage I/II/III Receives: Behavioral: Computer-assisted teaching format group | |
| Plaque-disclosing group | Patients diagnosed with periodontal disease stage I/II/III Receives: Behavioral: Plaque-disclosing group | |
| Intra-oral Camera group | Patients diagnosed with periodontal disease stage I/II/III Receives: Behavioral: Intra-oral camera group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 3 months
Secondary outcomes (3)
Evaluation of probing pocket depth
Probing pocket depth (distance from the top of the marginal gingiva to the bottom of the pocket)
Measured: 3 months
Evaluation of the gingival attachment level
Gingival attachment level (distance separating the cemento-enamel junction from the bottom of the pocket)
Measured: 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)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2021
- Study startMar 2021 (estimated)
- Primary completionMar 2021 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal Disease Stage I/II/IIIStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04745598
- Sponsor's protocol ID
- 8091
- Acronym
- HygParo
- Status last verified
- Feb 2021
- First submitted
- 4 Feb 2021
- Last updated
- 9 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact Evaluation of Personalized Oral Hygiene Education on Periodontal Patients Stage I/II/III
- ClinicalTrials.gov ID
- NCT04745598
- Acronym / sponsor ID
- HygParo / 8091
- Conditions
- Periodontal Disease Stage I/II/III
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Mar 2021 (estimated)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 9 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control group: Dental model | – | Behavioral: Control group: Dental ModelPatients diagnosed with periodontal disease stage I/II/III |
| Computer-assisted teaching format group | – | Behavioral: Computer-assisted teaching format groupPatients diagnosed with periodontal disease stage I/II/III |
| Plaque-disclosing group | – | Behavioral: Plaque-disclosing groupPatients diagnosed with periodontal disease stage I/II/III |
| Intra-oral Camera group | – | Behavioral: Intra-oral camera groupPatients diagnosed with periodontal disease stage I/II/III |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Periodontal patients in maintenance phase treated at the Periodontics Department of the Civil Hospital of Strasbourg
Key inclusion criteria (9 listed)
- ≥ 18 years old
- Subject having signed an informed consent
- Subjects with periodontal disease Stage I/II/III :
- ≥ 15 teeth/implants
- Bleeding index at ≥ 25%
Key exclusion criteria (12 listed)
- <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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Control group: Dental model |
| Computer-assisted teaching format group- Patients receive a Powerpoint presentation containing: | Behavioural | Computer-assisted teaching format group |
| 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 | Behavioural | Plaque-disclosing group |
| Intra-oral camera group- An ACTEON Soprocare® intraoral camera is used during the examination and explanation of oral hygiene strategies. | Behavioural | Intra-oral Camera group |
Primary outcome
Evaluation of the plaque index
Time frame: 3 months
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
Evaluation of the gingival index
Time frame: 3 months
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 secondary outcomes
Evaluation of probing pocket depth
Time frame: 3 months
Evaluation of the gingival attachment level
Time frame: 3 months
Psychological determinants of the HAPA (Health Action Process Approach)
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2021.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontal Disease Stage I/II/III, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Olivier HUCK (+33 3 88 11 69 47, olivier.huck@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the plaque index (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2021.