Pregnancy Women and Individual Oral Prophylaxis in the Control of Gingival Inflammation (PRE-IOP)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sonicare DiamondClean 9000 Philips®, HydroSonic Easy Curaden®, Manual toothbrush Oral-B 123, Manual toothbrush Curaprox CS 5460.
- Who it may be relevant to
- Registry conditions: Pregnant Woman. Basic parameters: 18 years — 40 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Clinical Comparison of Two Sonic Electric Toothbrushes and Two Manual Toothbrushes, Used Under Normal Oral Hygiene Conditions, on the Reduction of Gingival Inflammation in Pregnant Women Aged 18 to 40: Randomized Clinical Trial
Overview
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
- Device Sonicare DiamondClean 9000 Philips®
Brush teeth with the electric toothbrush daily during 3 months - Device HydroSonic Easy Curaden®
Brush teeth with the hydrosonic toothbrush daily during 3 months - Device Manual toothbrush Oral-B 123
Brush teeth with the manual toothbrush daily during 3 months - Device Manual toothbrush Curaprox CS 5460
Brush teeth with the manual toothbrush daily during 3 months
Primary outcome measures
- Incidence of gingival bleeding from baseline during woman pregnancy [Time frame: T1 (Baseline), T2 (+ 1 month) and T3 (+ 3 months)]
Secondary outcome measures (6)
- Effect on gingival bleeding [Time frame: T1 (Baseline), T2 (+ 1 month) and T3 (+ 3 months)]
- Effect on gingival inflammation [Time frame: T1 (Baseline), T2 (+ 1 month) and T3 (+ 3 months)]
- Effect on dental plaque [Time frame: T1 (Baseline), T2 (+ 1 month) and T3 (+ 3 months)]
- Effect on gingival attachment [Time frame: T1 (Baseline), T2 (+ 1 month) and T3 (+ 3 months)]
- Effect on Periodontal Pocket [Time frame: T1 (Baseline), T2 (+ 1 month) and T3 (+ 3 months)]
- Customer Satisfaction Score [Time frame: T1 (Baseline), T2 (+ 1 month) and T3 (+ 3 months)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
France · 1 center
- Clinique Majorelle — Nancy
Identifiers
NCT: NCT05945225 · PRE-IOP