NCT05945225

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

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

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Claude Bernard University · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pregnant Woman

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-11-01
• Primary completion: 2026-12-30
• Completion: 2027-09-30
• First posted: 2023-07-14
• Last updated: 2026-03-18

Locations

1 site across 1 country: France