Clinical trial NCT05639907: Miniscrew Stability and Peri-implant Inflammation When Precoated K21 vs Ethanol Control
Official title: A Comparison of Miniscrew Stability and Peri-implant Inflammation When Precoated With Antimicrobial Quaternary Ammonium Compound K21 vs Ethanol Control in Orthodontic Patients: a Triple-blind, Split-mouth, Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Inflammation Caused by the Placement of a Temporary Anchorage Device
Keywords: TAD
inflammation
orthodontics
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2022-12-07
Enrollment: 30
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Split mouth
Primary purpose: PREVENTION

Brief summary: To determine if coating miniscrews with K21 would increase the success rate of orthodontic miniscrews by reducing adjacent tissue inflammation.

Detailed description: The study design is a split mouth study where 2 miniscrews, one pretreated with K21 the other pretreated (experimental) with ethanol (placebo) are placed in the mouth for orthodontic therapy. All participants will receive 2 or more orthodontic miniscrews with equal numbers of experimental and control pretreatment solutions. Mobility will be assessed at the 4 and 8 week follow up appointments by gentle manipulation with cotton pliers. Clinical success will be defined as maintenance of stability for a period of 8 weeks. Peri-implant inflammation will be assessed at follow up appointments by looking for signs of soft-tissue inflammation (redness, swelling) where possible.

Eligibility criteria: Inclusion Criteria:

1. Good general health, with no significant medical findings
2. Requiring at least two miniscrews in their treatment plans (i.e., most participants will have two miniscrews, but some may receive four or six as indicated by their individual treatment plan)
3. Miniscrew pairs indicated with comparable anatomical positions and comparable mechanics (direct vs. indirect anchorage).

Exclusion Criteria:

1. Recent or ongoing use of antiresorptive pharmacological agents contraindicating the use of orthodontic miniscrews
2. Less than 12 years of age
3. Heavy tobacco use (\>10 cigarettes/day)
4. Peri-implant tissues must be observable at follow-up appointments
5. Being unable or unwilling to consent to the study

Primary outcomes:
measure: TAD motility
timeFrame: 8 weeks
measure: Peri-implant inflammation
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado School of Dental Medicine
state: Colorado
Study officials:
References:
citation: Alharbi F, Almuzian M, Bearn D. Miniscrews failure rate in orthodontics: systematic review and meta-analysis. Eur J Orthod. 2018 Sep 28;40(5):519-530. doi: 10.1093/ejo/cjx093.
citation: Cheng SJ, Tseng IY, Lee JJ, Kok SH. A prospective study of the risk factors associated with failure of mini-implants used for orthodontic anchorage. Int J Oral Maxillofac Implants. 2004 Jan-Feb;19(1):100-6.
citation: Daood U, Matinlinna JP, Pichika MR, Mak KK, Nagendrababu V, Fawzy AS. A quaternary ammonium silane antimicrobial triggers bacterial membrane and biofilm destruction. Sci Rep. 2020 Jul 3;10(1):10970. doi: 10.1038/s41598-020-67616-z.
citation: Kok ESK, Lim XJ, Chew SX, Ong SF, See LY, Lim SH, Wong LA, Davamani F, Nagendrababu V, Fawzy A, Daood U. Quaternary ammonium silane (k21) based intracanal medicament triggers biofilm destruction. BMC Oral Health. 2021 Mar 12;21(1):116. doi: 10.1186/s12903-021-01470-x.
citation: Meghil MM, Rueggeberg F, El-Awady A, Miles B, Tay F, Pashley D, Cutler CW. Novel Coating of Surgical Suture Confers Antimicrobial Activity Against Porphyromonas gingivalis and Enterococcus faecalis. J Periodontol. 2015 Jun;86(6):788-94. doi: 10.1902/jop.2015.140528. Epub 2015 Feb 23.