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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Pregnant Woman
• Intervention / Treatment: Device: Sonicare DiamondClean 9000 Philips®; Device: HydroSonic Easy Curaden®; Device: Manual toothbrush Curaprox CS 5460; Device: Manual toothbrush Oral-B 123

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nancy, France
    • Clinique Majorelle

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group using sonic toothbrush; Patient will be asked to use a sonic toothbrush for 3 months	Device: Sonicare DiamondClean 9000 Philips®; Brush teeth with the electric toothbrush daily during 3 months
Experimental: Group using hydrosonic toothbrush; Patient will be asked to use a hydrosonic toothbrush for 3 months	Device: HydroSonic Easy Curaden®; Brush teeth with the hydrosonic toothbrush daily during 3 months
Experimental: Group using manual toothbrush with 5460 strands; Patients will be asked to use a manual toothbrush with 5460 strands for 3 months	Device: Manual toothbrush Curaprox CS 5460; Brush teeth with the manual toothbrush daily during 3 months
Placebo Comparator: Group using manual toothbrush; Patients will be asked to use a manual toothbrush for 3 months	Device: Manual toothbrush Oral-B 123; Brush teeth with the manual toothbrush daily during 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of gingival bleeding from baseline during woman pregnancy	Change of gingival inflammation in pregnant woman using manual or electric toothbrushes in daily practice	T1 (Baseline), T2 (+ 1 month) and T3 (+ 3 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect on gingival bleeding	Bleeding on Probing	T1 (Baseline), T2 (+ 1 month) and T3 (+ 3 months)
Effect on gingival inflammation	gingival index	T1 (Baseline), T2 (+ 1 month) and T3 (+ 3 months)
Effect on dental plaque	plaque index	T1 (Baseline), T2 (+ 1 month) and T3 (+ 3 months)
Effect on gingival attachment	clinical attachment loss	T1 (Baseline), T2 (+ 1 month) and T3 (+ 3 months)
Effect on Periodontal Pocket	Periodontal Pocket Probing Depth	T1 (Baseline), T2 (+ 1 month) and T3 (+ 3 months)
Customer Satisfaction Score	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	T1 (Baseline), T2 (+ 1 month) and T3 (+ 3 months)

Collaborators and Investigators

• Sponsor: Claude Bernard University
• Collaborators: Elsan; University of Nancy

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): September 30, 2027

Study Registration Dates

• First Submitted: July 6, 2023
• First Submitted That Met QC Criteria: July 6, 2023
• First Posted (Actual): July 14, 2023

Study Record Updates

• Last Update Posted (Actual): March 18, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: manual toothbrush; pregnant woman; gingival inflammation; oral prophylaxis; electric sonic toothbrush
• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Infections; Gingival Diseases; Gingivitis
• Other Study ID Numbers: PRE-IOP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No