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

NCT05945225 | Enrolling By Invitation DMC

• 1 other identifier: PRE-IOP
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

manual toothbrush; electric sonic toothbrush; oral prophylaxis; pregnant woman; gingival inflammation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Effect on gingival bleeding

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

• Effect on gingival inflammation

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

• Effect on dental plaque

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

• Effect on gingival attachment

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

• Effect on Periodontal Pocket

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

Study Arms (4)

Group using sonic toothbrush

EXPERIMENTAL

Patient will be asked to use a sonic toothbrush for 3 months

Device: Sonicare DiamondClean 9000 Philips®

Group using hydrosonic toothbrush

EXPERIMENTAL

Patient will be asked to use a hydrosonic toothbrush for 3 months

Device: HydroSonic Easy Curaden®

Group using manual toothbrush with 5460 strands

EXPERIMENTAL

Patients will be asked to use a manual toothbrush with 5460 strands for 3 months

Device: Manual toothbrush Curaprox CS 5460

Group using manual toothbrush

PLACEBO COMPARATOR

Patients will be asked to use a manual toothbrush for 3 months

Device: Manual toothbrush Oral-B 123

Interventions

Sonicare DiamondClean 9000 Philips® DEVICE

Brush teeth with the electric toothbrush daily during 3 months

Group using sonic toothbrush

HydroSonic Easy Curaden® DEVICE

Brush teeth with the hydrosonic toothbrush daily during 3 months

Group using hydrosonic toothbrush

Manual toothbrush Oral-B 123 DEVICE

Brush teeth with the manual toothbrush daily during 3 months

Group using manual toothbrush

Manual toothbrush Curaprox CS 5460 DEVICE

Brush teeth with the manual toothbrush daily during 3 months

Group using manual toothbrush with 5460 strands

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female, 18 to 40 years of age
• 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

Sponsors & Collaborators

• Claude Bernard University: lead
• University of Nancy: collaborator
• Elsan: collaborator

Study Sites (1)

Clinique Majorelle

Nancy, France

Location

MeSH Terms

Conditions

Gingivitis

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: July 6, 2023
• First Posted: July 14, 2023
• Study Start: November 1, 2023
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): September 30, 2027
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)