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If you've been skipping regular dental checkups because you don't have any tooth pain, beware: you may have periodontal disease and not even feel it! Your gums and jawbone are ju

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

st as important as your teeth for oral health.

What is periodontal disease?

Periodontal disease is a serious bacterial infection that attacks the gums and bones that support yo

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

r teeth. If the disease is not treated, it can lead to tooth loss. According to the American Dental Hygienists' Association, 75 percent of Americans have some form of periodontal

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

disease. Unfortunately, 50 percent of Americans do not receive regular dental care.

There are different types of periodontal disease:

1) Gingivitis: Gingivitis usually causes l

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

ittle or no pain. Your gums appear red or swollen, and they bleed easily. Fortunately, gingivitis can be reversed with immediate treatment at the dentist's office and consistent

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

omecare.

2) Aggressive periodontitis: The word "aggressive" is appropriate for this type of periodontal disease, because it quickly destroys the bones and gums that attach to an

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

support your teeth.

3) Chronic periodontitis: The most common effects of chronic periodontitis are increased tissue inflammation, receding gums, deeper pockets at the gumline,

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

and destruction of the bone and gums that attach to and support your teeth.

One of the major reasons for periodontal disease (and the most preventable one) is the lack of proper

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

homecare for your teeth and gums. Periodontal disease also may arise from tobacco use, stress, clenching or grinding your teeth (bruxism), diabetes, HIV/AIDS infections, malnutri

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

ion, and hormonal changes (such as during puberty, menstruation, pregnancy, and menopause). No matter how it has occurred, periodontal disease requires regular dental treatments

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

nd rigorous homecare procedures.

What if your gums and teeth don't hurt?

Periodontal disease generally is painless. So even if your gums and teeth don't hurt, you should be on

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

the lookout for signs of infection, including:

1) Gums that bleed, especially when brushing or flossing your teeth
2) Gums that are red, swollen, or unusually shiny
3)

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

Receding gums
4) Persistent bad breath
5) Pus that appears between your teeth and gums
6) Teeth that feel loose or feel different when you bite together
7) Pa

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

tial dentures that don't feel like they fit right

Are you ignoring tooth pain?

As periodontal disease escalates, you may begin to experience increasing sensitivity in your teet

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

h and gums. Don't become a statistic of neglect! For example, in one study by the Centers for Disease Control, even if people feel pain, they don't always seek dental care. Recen

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

tooth pain was reported by nearly 22 percent of adults; 14.5 percent were 20-64 years old, and 7 percent were over 65 years old. Within these age groups, younger and older non-H

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

spanic blacks, and people with lower socioeconomic status were more likely to report pain but not have dental care.

In another study, researchers at the University of Florida ha

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

ve reported that rural residents and people who wait until problems arise are more likely to wait too long to get dental care. In contrast, urban residents or people who prefer t

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

take a more proactive approach to dental care are less likely to ignore tooth pain.

Whether or not you and your family members are currently experiencing any oral pain, it's im

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

ortant to have regular checkups. Although August is National Pain Awareness Month, you shouldn't wait for a painful emergency. The best approach is to prevent dental problems now

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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