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Pregnancy Women and Individual Oral Prophylaxis in the Control of Gingival Inflammation (PRE-IOP)
Sponsor: Claude Bernard University
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.
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
Key Details
Gender
FEMALE
Age Range
18 Years - 40 Years
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2023-11-01
Completion Date
2027-09-30
Last Updated
2026-03-18
Healthy Volunteers
No
Conditions
Interventions
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
Locations (1)
Clinique Majorelle
Nancy, France