NCT05619796 - 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)

Abd El Fatah YAM, Khattab NMA, Gomaa YF, Elheeny AAH
Cone-beam computed tomography analysis of primary root canals transportation and dentin loss after instrumentation with two-pediatric rotary files. BMC Oral Health. 2022 May 31;22(1):214. doi: 10.1186/s12903-022-02245-8.
Barr ES, Kleier DJ, Barr NV
Use of nickel-titanium rotary files for root canal preparation in primary teeth. Pediatr Dent. 2000 Jan-Feb;22(1):77-8.
Elheeny AAH, Abdelmotelb MA
Postoperative pain after primary molar pulpectomy using rotary or reciprocating single files: A superior, parallel, randomized clinical trial. Int J Paediatr Dent. 2022 Nov;32(6):819-827. doi: 10.1111/ipd.12959. Epub 2022 May 5.
Jeevanandan G, Govindaraju L
Clinical comparison of Kedo-S paediatric rotary files vs manual instrumentation for root canal preparation in primary molars: a double blinded randomised clinical trial. Eur Arch Paediatr Dent. 2018 Aug;19(4):273-278. doi: 10.1007/s40368-018-0356-6. Epub 2018 Jul 12.
Mohamed RH, Abdelrahman AM, Sharaf AA
Evaluation of rotary file system (Kedo-S-Square) in root canal preparation of primary anterior teeth using cone beam computed tomography (CBCT)-in vitro study. BMC Oral Health. 2022 Jan 18;22(1):13. doi: 10.1186/s12903-021-02021-0.

Assessment of Clinical and Radiographic Efficiency of Manual and Pediatric Rotary File Systems in Primary Root Canal Preparation

Clinical trial NCT05619796 - References