NCT05299489 - 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)

Dhareula A, Goyal A, Gauba K, Bhatia SK, Kapur A, Bhandari S
A clinical and radiographic investigation comparing the efficacy of cast metal and indirect resin onlays in rehabilitation of permanent first molars affected with severe molar incisor hypomineralisation (MIH): a 36-month randomised controlled clinical trial. Eur Arch Paediatr Dent. 2019 Oct;20(5):489-500. doi: 10.1007/s40368-019-00430-y. Epub 2019 Mar 19.
Gatón-Hernandéz P, Serrano CR, da Silva LAB, de Castañeda ER, da Silva RAB, Pucinelli CM, Manton D, Ustrell-Torrent JM, Nelson-Filho P
Minimally interventive restorative care of teeth with molar incisor hypomineralization and open apex-A 24-month longitudinal study. Int J Paediatr Dent. 2020 Jan;30(1):4-10. doi: 10.1111/ipd.12581. Epub 2019 Oct 24.
Lygidakis NA, Wong F, Jälevik B, Vierrou AM, Alaluusua S, Espelid I
Best Clinical Practice Guidance for clinicians dealing with children presenting with Molar-Incisor-Hypomineralisation (MIH): An EAPD Policy Document. Eur Arch Paediatr Dent. 2010 Apr;11(2):75-81.
Melin L, Lundgren J, Malmberg P, Norén JG, Taube F, Cornell DH
XRMA and ToF-SIMS Analysis of Normal and Hypomineralized Enamel. Microsc Microanal. 2015 Apr;21(2):407-21. doi: 10.1017/S1431927615000033. Epub 2015 Feb 12.
Silva MJ, Scurrah KJ, Craig JM, Manton DJ, Kilpatrick N
Etiology of molar incisor hypomineralization - A systematic review. Community Dent Oral Epidemiol. 2016 Aug;44(4):342-53. doi: 10.1111/cdoe.12229. Epub 2016 Apr 28. Review.
Weerheijm KL
Molar incisor hypomineralization (MIH): clinical presentation, aetiology and management. Dent Update. 2004 Jan-Feb;31(1):9-12.

Clinical Randomized Controlled Trial To Compare Direct and Indirect Composite Restoration in Children With Molar Incisor Hypomineralization Patients (MIH)

Details for clinical trial NCT05299489

Clinical trial NCT05299489 - References