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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-01

Study Completion Date

2026-03-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Pregnant Woman

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Group using sonic toothbrush

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

Group Type EXPERIMENTAL

Sonicare DiamondClean 9000 Philips®

Intervention Type DEVICE

Brush teeth with the electric toothbrush daily during 3 months

Group using hydrosonic toothbrush

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

Group Type EXPERIMENTAL

HydroSonic Easy Curaden®

Intervention Type DEVICE

Brush teeth with the hydrosonic toothbrush daily during 3 months

Group using manual toothbrush with 5460 strands

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

Group Type EXPERIMENTAL

Manual toothbrush Curaprox CS 5460

Intervention Type DEVICE

Brush teeth with the manual toothbrush daily during 3 months

Group using manual toothbrush

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

Group Type PLACEBO_COMPARATOR

Manual toothbrush Oral-B 123

Intervention Type DEVICE

Brush teeth with the manual toothbrush daily during 3 months

Interventions

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Sonicare DiamondClean 9000 Philips®

Brush teeth with the electric toothbrush daily during 3 months

Intervention Type DEVICE

HydroSonic Easy Curaden®

Brush teeth with the hydrosonic toothbrush daily during 3 months

Intervention Type DEVICE

Manual toothbrush Oral-B 123

Brush teeth with the manual toothbrush daily during 3 months

Intervention Type DEVICE

Manual toothbrush Curaprox CS 5460

Brush teeth with the manual toothbrush daily during 3 months

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No