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To determine if coating miniscrews with K21 would increase the success rate of orthodontic miniscrews by reducing adjacent tissue inflammation.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| K21 Cavity cleanser-coated TAD | Experimental | A TAD to be placed is coated with K21 solution. The solution is allowed to evaporate to dryness, leaving a K21-rich film. The TAD is placed following the University TAD placement protocol. |
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| Ethanol Control | Placebo Comparator | A TAD to be placed is coated with ethanol solution. The solution is allowed to evaporate to dryness (no residue is expected). The TAD is placed following the University TAD placement protocol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| K21 Cavity cleanser | Device | K21 Cavity cleanser is rinsed over the TAD and allowed to dry. The TAD is placed where needed for orthodontic therapy following the Department of Orthodontics protocols. |
| Measure | Description | Time Frame |
|---|---|---|
| TAD motility | The motility of a TAD is evaluated by gentle manipulation with cotton pliers. Clinical failures will be defined as a mobility greater than or equal to 1mm. Clinical success will be defined as maintenance of stability for a period of 8 weeks. | 8 weeks |
| Peri-implant inflammation | Inspection for signs of soft-tissue inflammation (redness, swelling) immediately around the TAD. The Loe-Silness Index scale will be used to assess any inflammation. The Loe-Silness Index scale is between 0 and 3 where a 0 is normal soft tissue, 1 is mild inflammation where the tissue color is slightly red and the tissue does not bleed upon probing, 2 is moderate inflammation where the tissue color is red with edema and bleeds upon probing, and 3 is severe inflammation where the tissue bleeds with little or no probing has edema and has ulcers. | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clifton M Carey, PhD | Contact | 3037241046 | clifton.carey@cuanschutz.edu | |
| Gerald Minick, DDS | Contact | 3037247830 | gerald.minick@cuanschutz.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado School of Dental Medicine | Recruiting | Aurora | Colorado | 80045 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29315365 | Result | 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. | |
| 14982362 | Result | 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. |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Split mouth
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There will be random allocation established, such that as a study participant is enrolled the clinician will receive a numbered envelope that contains the information for which TAD placement site will receive a TAD coated with solution A or B. The identification of Solution A or B is kept secret in an envelope stored in the office of the Chair of the Orthodontic Department (U Colo, Sch Dent Med). The patient, clinical operator, Investigator and Outcomes assessor is not aware which solution (A or B) is the experimental or placebo.
| Ethanol control | Device | Ethanol is rinsed over the TAD and allowed to dry. The TAD is placed where needed for orthodontic therapy following the Department of Orthodontics protocols. |
|
| 32620785 | Result | 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. |
| 33711992 | Result | 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. |
| 25703732 | Result | 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. |