NCT02022865 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Goldenberg RL, Culhane JF, Iams JD, Romero R
Epidemiology and causes of preterm birth. Lancet. 2008 Jan 5;371(9606):75-84. doi: 10.1016/S0140-6736(08)60074-4. Review.
Offenbacher S, Jared HL, O'Reilly PG, Wells SR, Salvi GE, Lawrence HP, Socransky SS, Beck JD
Potential pathogenic mechanisms of periodontitis associated pregnancy complications. Ann Periodontol. 1998 Jul;3(1):233-50.

Correlation Between Inflammatory Markers in Gingival Crevicular Fluid, Serum and Amniotic Fluids in Periodontal Pregnant Women

Clinical trial NCT02022865 - References