Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Clinical Trials in France / NCT05945225
Enrolling by invitation Not applicable

Pregnancy Women and Individual Oral Prophylaxis in the Control of Gingival Inflammation (PRE-IOP)

NCT05945225 · tracked via the Priya Life Science France tracker
Sponsor
Claude Bernard University
Phase
Not applicable
Started
2023-11-01
Last updated
2026-03-18

Condition(s) studied

Pregnant Woman

Investigational drug(s) / intervention(s)

Sonicare DiamondClean 9000 Philips®HydroSonic Easy Curaden®Manual toothbrush Oral-B 123Manual toothbrush Curaprox CS 5460

Sonicare DiamondClean 9000 Philips®: Brush teeth with the electric toothbrush daily during 3 months

HydroSonic Easy Curaden®: Brush teeth with the hydrosonic toothbrush daily during 3 months

Manual toothbrush Oral-B 123: Brush teeth with the manual toothbrush daily during 3 months

Manual toothbrush Curaprox CS 5460: Brush teeth with the manual toothbrush daily during 3 months

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
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

Primary outcome measure(s)

  • 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

Trial sites (1)

FacilityCityRegionStatus
Clinique Majorelle Nancy France

More Claude Bernard University trials in France

Complications in Pediatric Mechanical Circulatory Assistance: Evaluation of Infection Management. Recruiting
Toothbrushes in Daily Practice in Patients With Fixed Orthodontic Appliances Recruiting

Other trials for the same condition

Physical Activity and Sedentary Behavior During Pregnancy Recruiting
Study of General Foetal Movements Using Ultrasound Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05945225 on ClinicalTrials.gov ↗ ← All trials in France