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

Enrolling by invitation · Not applicable

Conditions studied: Pregnant Woman

In brief

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.

Key facts

Study ID

NCT05945225

Run by

Claude Bernard University

People needed

120

Starts

2023-11-01

Expected to finish

2027-09-30

Last updated by the study team

2026-03-18

Who can join

Age: 18 and older, up to 40. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Female, 18 to 40 years of age
• 15-18 weeks pregnant
• Acceptance of study terms and conditions
• Signature of informed consent form

You may not qualify if…

• 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

Where it is running

• Clinique Majorelle — Nancy, France

Full record on ClinicalTrials.gov

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