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

Claude Bernard University

Status: Invitation-only

Conditions: Pregnant Woman

Treatments: Device: Sonicare DiamondClean 9000 Philips®; Device: Manual toothbrush Oral-B 123; Device: Manual toothbrush Curaprox CS 5460; Device: HydroSonic Easy Curaden®

Study type: Interventional

Funder types: Other

Identifiers

NCT05945225

PRE-IOP

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 4 patient groups, including a placebo group

Group using sonic toothbrush

Experimental group

Description:

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

Treatment:

Device: Sonicare DiamondClean 9000 Philips®

Group using hydrosonic toothbrush

Experimental group

Description:

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

Treatment:

Device: HydroSonic Easy Curaden®

Group using manual toothbrush with 5460 strands

Experimental group

Description:

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

Treatment:

Device: Manual toothbrush Curaprox CS 5460

Group using manual toothbrush

Placebo Comparator group

Description:

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

Treatment:

Device: Manual toothbrush Oral-B 123