Periodontal Disease
Conditions
Keywords
Periodontal Disease, Interdental Brushes
Brief summary
The aim of this exploratory study is to evaluate the efficacy of the tested interdental brush versus comparative interdental brushes in adults with periodontal disease, over a 4-week period.
Detailed description
This study will take place at a single center as an intra-individual, split mouth, randomized, comparative study to evaluate the efficacy of the tested interdental brushes versus the comparative interdental brushes in adults with periodontal disease, over a 4-week period. 3 visits are planned: * Visit 0: Pre-inclusion (Day -21 to Day 1): Information of the study given to subject, checking eligibility criteria orally * Visit 1: Inclusion visit (Day 1): Randomization and Start of interdental brushes use (tested and comparative on each split-mouth) * Visit 2: End of study (Day 29 +/-7 days , i.e. 1 month after inclusion)
Interventions
OTHERTest interdental brush
Interdental brush to be used twice a day during the whole study.
OTHERComparative interdental brush
Interdental brush to be used twice a day during the whole study.
Sponsors
Pierre Fabre Dermo Cosmetique
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Intra-individual split-mouth randomized comparative study in adults with periodontal disease. Subjects enrolled in the study will use the test interdental brush on one side of the mouth and comparative interdental brush on contralateral side of the mouth for 4 weeks.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Subject aged between 18 and 80 years included * Subject having signed his/her written informed consent for his/her participation in the study * Subject diagnosed with active generalized periodontal disease (excluding gingivitis) * Subject having at least 20 natural teeth (10 teeth on each side (right and left)) Non-inclusion criteria: * Subject unable to understand the information given including study procedures (for linguistic or psychiatric reasons) and to give his/her consent in writing and to report required information in a questionnaire * For woman of childbearing potential: pregnant or breastfeeding or planning to be pregnant during the study * Subject having any other oral condition than periodontal disease (ex: dermatologic ulcers), or any orthodontic conditions liable to interfere with the study assessment or considered by the investigator hazardous for the subject or incompatible with study requirements * Systemic treatment or topical treatment/product currently taken/applied in the mouth liable to interfere with study assessments according to the investigator or planned to be taken/applied during the study * Subject has received periodontal therapy (scaling, root planing, surgery, etc.) within 2 months before the inclusion * Subject who has undergone oral or gum surgery within 2 months before the inclusion, or planned to be performed during the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect on dental plaque | Change from Visit 1 (Day 1) to Visit 2 (Day 29). | Dental plaque (%) will be assessed according to the O'Leary method on each side of the mouth. |
| Effect on gingival bleeding | Change from Visit 1 (Day 1) to Visit 2 (Day 29). | Gingival bleeding (%) will be assessed on each side of the mouth. |
| Effect on pocket depth | Change from Visit 1 (Day 1) to Visit 2 (Day 29). | Pocket depth (mm) will be assessed on each side of the mouth. |
| Interdental hygiene assessment by subject | Visit 2 (Day 29). | Interdental hygiene on each side of the mouth at Visit 2 compared to Visit 1 will be assessed by the subject using a 4-point scale (0: no change, -1: slightly improvement, 2: improvement, 3: significant improvement) |
| Adverse events recording | From Visit 1 (Day 1) to Visit 2 (Day 29) | Adverse events occurrence will be determined by the subject spontaneous reporting, the investigator's non-leading questioning and his/her clinical evaluation |
| Acceptability Questionnaire assessment | Visit 2 (Day 29) | Acceptability questionnaire regarding the use of the interdental brushes will be completed by the subject. |
Countries
Belgium
Contacts
CONTACTAdeline BACQUEY
PRINCIPAL_INVESTIGATORSelena TOMA, Pr.
UC Louvain
Outcome results
None listed