Pregnancy Women and Individual Oral Prophylaxis in the Control of Gingival Inflammation (PRE-IOP)
This study, called PRE-IOP, aims to find out which type of toothbrush works best for pregnant women to keep their gums healthy. Many pregnant women experience gum inflammation, or gingivitis, often starting around their third month of pregnancy. This is often caused by bacteria in the mouth and made worse by pregnancy hormones. Keeping teeth clean is very important to control this. While electric toothbrushes are often easier to use, it's not yet clear if they are more effective than manual ones for pregnant women. This study will compare different manual and electric toothbrushes to see which ones are best at reducing gum inflammation during pregnancy.
At a glance
What is this study about?
During pregnancy, many women experience changes in their gums, sometimes leading to a condition called gingivitis. This simply means your gums can become a bit red, swollen, and might bleed easily. It's quite common, affecting between 35% and 100% of pregnant women, especially from the third month onwards. This happens because of a build-up of bacteria in your mouth, combined with the normal increase in hormones during pregnancy, which makes your gums more sensitive.
Keeping your teeth and gums very clean at home and with regular dental check-ups is key to managing gingivitis. There are many different types of toothbrushes available, both manual and electric. Electric toothbrushes, like sonic ones, are often thought to be easier to use, but it's not completely clear which type works best for pregnant women to reduce gum inflammation.
This study, called PRE-IOP, is setting out to answer that exact question. We want to compare how well two different manual toothbrushes and two different sonic electric toothbrushes help pregnant women control the plaque on their teeth and reduce gum inflammation. By taking part, you could help us understand the best ways for pregnant women to keep their gums healthy.
Key takeaways
- This study compares different toothbrushes to find the best one for pregnant women's gum health.
- Many pregnant women experience gum inflammation (gingivitis).
- Good oral hygiene is crucial for controlling gum inflammation during pregnancy.
- The study looks at both manual and electric sonic toothbrushes.
- Participation involves using a specific toothbrush and attending regular check-ups.
Who may be eligible?
To be part of this study, you need to be a woman between 18 and 40 years old, and you should be about 15 to 18 weeks pregnant when the study starts. You'll also need to understand and agree to the study's terms.
There are some reasons why you might not be able to join. For example, if you have advanced gum disease (where your gums are seriously affected) or have received treatment for gum disease in the past. Also, if you're currently having dental work or orthodontic treatment (like braces), or if you have fewer than 20 natural teeth (not counting wisdom teeth), you likely won't be able to participate.
Other reasons for not being able to join include taking medicines that affect your gums, regularly using special dental cleaning tools (like interdental brushes or floss more than once a week), having false teeth that you can take out, dental implants, or certain health conditions like blood disorders or diabetes. If you're on blood thinners or might have trouble following the study's instructions, you also wouldn't be able to join.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you a woman between 18 and 40 years old?
- Are you currently between 15 and 18 weeks pregnant?
- Do you not have severe gum disease or major dental problems?
- Are you generally healthy, without certain conditions like diabetes or bleeding disorders?
- Are you able to follow study instructions carefully?
What does participation involve?
If you decide to take part in this study, you'll be given a specific type of toothbrush – either one of two manual brushes or one of two electric sonic brushes. You'll be asked to use this toothbrush as instructed throughout the study. The study aims to compare how effectively these different toothbrushes help keep your gums healthy and reduce any inflammation. You will have regular check-ups with the study team, who will assess the health of your gums and the cleanliness of your teeth. The total duration of your participation in the study will be explained to you in detail.
Potential risks and benefits
Locations (1)
- Clinique MajorelleVerified postcodeNancy, France
Common questions
What is gingivitis?
Gingivitis is when your gums become inflamed, red, swollen, and can sometimes bleed, often due to bacteria in your mouth.
Why is gingivitis common in pregnant women?
It's common because pregnancy hormones can make your gums more sensitive and prone to inflammation, especially with bacteria present.
What will happen if I join the study?
You'll be given a type of toothbrush to use and will have check-ups to see how well it's helping your gums.
Do I have to pay to join the study?
No, clinical trials like this typically do not charge participants. Any materials related to the study will be provided.
Can I leave the study if I change my mind?
Yes, you can leave the study at any time without having to give a reason, and it won't affect your regular medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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