Pregnant Woman
Conditions
Keywords
manual toothbrush, electric sonic toothbrush, oral prophylaxis, pregnant woman, gingival inflammation
Brief summary
Gingivitis in pregnant women is a common inflammatory periodontal disease that appears from the third month of pregnancy with an overall prevalence of 35 to 100%. This condition is induced by oral biofilm and exacerbated by increased levels of sex steroid hormones characteristic of pregnancy. Strict bacterial plaque control with both professional and home oral hygiene is essential. Manual toothbrushes require a more specific manual technique for women, while sonic electric toothbrushes, due to their ease of use, might be an excellent for oral individual prophylaxis. Therefore, the question of which type of manual or electric toothbrush might be more effective in reducing gingival inflammation in pregnant women is still unresolved. In literature there are a large number of in vitro clinical studies on this topic, there are currently no clinical studies investigating this long-term clinical comparison. In this context, this study is a randomized clinical trial consisting of a comparative evaluation between two manual and two sonic electric toothbrushes in the efficacy of the control of plaque in order to reduce gingivitis in women during the period of pregnancy.
Interventions
DEVICESonicare DiamondClean 9000 Philips®
Brush teeth with the electric toothbrush daily during 3 months
DEVICEHydroSonic Easy Curaden®
Brush teeth with the hydrosonic toothbrush daily during 3 months
DEVICEManual toothbrush Oral-B 123
Brush teeth with the manual toothbrush daily during 3 months
DEVICEManual toothbrush Curaprox CS 5460
Brush teeth with the manual toothbrush daily during 3 months
Sponsors
Claude Bernard University
University of Nancy
Elsan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Female, 18 to 40 years of age * 15-18 weeks pregnant * Acceptance of study terms and conditions * Signature of informed consent form
Exclusion criteria
* Protected women * Stage II,III periodontal disease (i.e. PD ≥ 4 mm, and/or CAL ≥ 4 mm), generalized (\>30% od sites) * History or treatment of periodontal disease * Current dental or orthodontic treatment * Fewer than 20 natural teeth, excluding third molars * Taking medication affecting the gums and/or oral mucosa * Regular use (more than once a week) of interdental brushes and/or dental floss and/or mouthwash * Removable prosthesis * Dental implants * Systemic disorder such as blood disorders, diabetes, and risk of endocarditis infections * Anticoagulant treatment * Inability to follow protocol or non-cooperation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of gingival bleeding from baseline during woman pregnancy | T1 (Baseline), T2 (+ 1 month) and T3 (+ 3 months) | Change of gingival inflammation in pregnant woman using manual or electric toothbrushes in daily practice |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect on gingival bleeding | T1 (Baseline), T2 (+ 1 month) and T3 (+ 3 months) | Bleeding on Probing |
| Effect on gingival inflammation | T1 (Baseline), T2 (+ 1 month) and T3 (+ 3 months) | gingival index |
| Effect on dental plaque | T1 (Baseline), T2 (+ 1 month) and T3 (+ 3 months) | plaque index |
| Effect on gingival attachment | T1 (Baseline), T2 (+ 1 month) and T3 (+ 3 months) | clinical attachment loss |
| Effect on Periodontal Pocket | T1 (Baseline), T2 (+ 1 month) and T3 (+ 3 months) | Periodontal Pocket Probing Depth |
| Customer Satisfaction Score | T1 (Baseline), T2 (+ 1 month) and T3 (+ 3 months) | * the minimum and maximum values: 1, 7 * lower scores mean a worse outcome. * the minimum and maximum values: 1, 7 * lower scores mean a worse outcome. * the minimum and maximum values: 1, 7 * lower scores mean a worse outcome. The score range from 1 (minimum) to 7 (maximum). Lower score mean a worse outcome |
Countries
France
Outcome results
None listed