An interventional study of Sonicare DiamondClean 9000 Philips® and HydroSonic Easy Curaden® in Pregnant Woman, sponsored by Claude Bernard University. Enrolling by invitation at 1 site in France. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-03-18.
Sponsored by Claude Bernard University · Not applicable, Interventional, and Prevention
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.
631 studies on the registry are indexed under Gingivitis; 107 are open to participants now.
This study's planned enrollment of 120 is above the median of 66 across 507 interventional studies indexed under Gingivitis.
Browse Gingivitis studies →Claude Bernard University is the lead sponsor of 31 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patient will be asked to use a sonic toothbrush for 3 months
Device: Sonicare DiamondClean 9000 Philips®
Patient will be asked to use a hydrosonic toothbrush for 3 months
Device: HydroSonic Easy Curaden®
Patients will be asked to use a manual toothbrush with 5460 strands for 3 months
Device: Manual toothbrush Curaprox CS 5460
Patients will be asked to use a manual toothbrush for 3 months
Device: Manual toothbrush Oral-B 123
Brush teeth with the electric toothbrush daily during 3 months
Brush teeth with the hydrosonic toothbrush daily during 3 months
Brush teeth with the manual toothbrush daily during 3 months
Brush teeth with the manual toothbrush daily during 3 months
Incidence of gingival bleeding from baseline during woman pregnancy
Change of gingival inflammation in pregnant woman using manual or electric toothbrushes in daily practice
Time frame: T1 (Baseline), T2 (+ 1 month) and T3 (+ 3 months)
Effect on gingival bleeding
Bleeding on Probing
Time frame: T1 (Baseline), T2 (+ 1 month) and T3 (+ 3 months)
Effect on gingival inflammation
gingival index
Time frame: T1 (Baseline), T2 (+ 1 month) and T3 (+ 3 months)
Effect on dental plaque
plaque index
Time frame: T1 (Baseline), T2 (+ 1 month) and T3 (+ 3 months)
Effect on gingival attachment
clinical attachment loss
Time frame: T1 (Baseline), T2 (+ 1 month) and T3 (+ 3 months)
Effect on Periodontal Pocket
Periodontal Pocket Probing Depth
Time frame: T1 (Baseline), T2 (+ 1 month) and T3 (+ 3 months)
Customer Satisfaction Score
* 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
Time frame: T1 (Baseline), T2 (+ 1 month) and T3 (+ 3 months)
Plan to share: No
No publications or documents are linked to this record.
Started Nov 2023 (actual). Primary completion is estimated for Dec 2026, 37 months after the start.
Of 204 non-industry interventional studies with no phase under Gingivitis, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 18. This study's planned 37 months is above that.
Counting every sponsor, half of 257 studies reached it within 7 months; a quarter within 3 and three quarters within 15.
How these figures are worked out, and which studies are left out of them.
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Claude Bernard University