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

Pregnant Woman Clinical Trial

— PRE-IOP  

Official 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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05945225
• Other study ID #: PRE-IOP
• Status: Enrolling by invitation
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: March 30, 2026

Study information

• Verified date: October 2023
• Source: Claude Bernard University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 120
• Est. completion date: March 30, 2026
• Est. primary completion date: March 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Gingivitis
• Inflammation
• Pregnant Woman

Intervention

Device:
• Sonicare DiamondClean 9000 Philips®
Brush teeth with the electric toothbrush daily during 3 months
• HydroSonic Easy Curaden®
Brush teeth with the hydrosonic toothbrush daily during 3 months
• Manual toothbrush Oral-B 123
Brush teeth with the manual toothbrush daily during 3 months
• Manual toothbrush Curaprox CS 5460
Brush teeth with the manual toothbrush daily during 3 months

Locations

Country	Name	City	State
France	Clinique Majorelle	Nancy

Sponsors (3)

Lead Sponsor	Collaborator
Claude Bernard University	Elsan, University of Nancy

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Effect on gingival bleeding	Bleeding on Probing	T1 (Baseline), T2 (+ 1 month) and T3 (+ 3 months)
Secondary	Effect on gingival inflammation	gingival index	T1 (Baseline), T2 (+ 1 month) and T3 (+ 3 months)
Secondary	Effect on dental plaque	plaque index	T1 (Baseline), T2 (+ 1 month) and T3 (+ 3 months)
Secondary	Effect on gingival attachment	clinical attachment loss	T1 (Baseline), T2 (+ 1 month) and T3 (+ 3 months)
Secondary	Effect on Periodontal Pocket	Periodontal Pocket Probing Depth	T1 (Baseline), T2 (+ 1 month) and T3 (+ 3 months)
Secondary	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)