Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT05945225

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

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.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Conditions

Pregnant Woman Gingival Diseases Gingivitis Infections Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Clinique Majorelle

Nancy, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sonicare DiamondClean 9000 Philips®

Device

Brush teeth with the electric toothbrush daily during 3 months

HydroSonic Easy Curaden®

Device

Brush teeth with the hydrosonic toothbrush daily during 3 months

Manual toothbrush Oral-B 123

Device

Brush teeth with the manual toothbrush daily during 3 months

Manual toothbrush Curaprox CS 5460

Device

Brush teeth with the manual toothbrush daily during 3 months

Primary outcomes

  1. Incidence of gingival bleeding from baseline during woman pregnancy

    Time frame: T1 (Baseline), T2 (+ 1 month) and T3 (+ 3 months)

    Change of gingival inflammation in pregnant woman using manual or electric toothbrushes in daily practice

Secondary outcomes

  1. Effect on gingival bleeding

    Time frame: T1 (Baseline), T2 (+ 1 month) and T3 (+ 3 months)

    Bleeding on Probing

  2. Effect on gingival inflammation

    Time frame: T1 (Baseline), T2 (+ 1 month) and T3 (+ 3 months)

    gingival index

  3. Effect on dental plaque

    Time frame: T1 (Baseline), T2 (+ 1 month) and T3 (+ 3 months)

    plaque index

  4. Effect on gingival attachment

    Time frame: T1 (Baseline), T2 (+ 1 month) and T3 (+ 3 months)

    clinical attachment loss

  5. Effect on Periodontal Pocket

    Time frame: T1 (Baseline), T2 (+ 1 month) and T3 (+ 3 months)

    Periodontal Pocket Probing Depth

  6. Customer Satisfaction Score

    Time frame: T1 (Baseline), T2 (+ 1 month) and T3 (+ 3 months)

    • the minimum and maximum values: 1, 7
    • lower scores mean a worse outcome.
    • the minimum and maximum values: 1, 7
    • lower scores mean a worse outcome.
    • the minimum and maximum values: 1, 7
    • lower scores mean a worse outcome. The score range from 1 (minimum) to 7 (maximum). Lower score mean a worse outcome

Sponsors and collaborators

Lead sponsor

Claude Bernard University

Other

Collaborators

  • Elsan
  • University of Nancy

Registry information

Official study 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

Acronym: PRE-IOP

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Jul 14, 2023
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.