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

Study Overview
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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.

Official Title
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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

Conditions
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Pregnant Woman

Intervention / Treatment
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* Device: Sonicare DiamondClean 9000 Philips®
* Device: HydroSonic Easy Curaden®
* Device: Manual toothbrush Oral-B 123
* Device: Manual toothbrush Curaprox CS 5460


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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manual toothbrush, electric sonic toothbrush, oral prophylaxis, pregnant woman, gingival inflammation