Back to resultsMiniscrew Stability and Peri-implant Inflammation When Precoated K21 vs Ethanol Control
Primary Purpose
Inflammation Caused by the Placement of a Temporary Anchorage Device
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
K21 Cavity cleanser
Ethanol control
Sponsored by
About this trial
This is an interventional prevention trial for Inflammation Caused by the Placement of a Temporary Anchorage Device focused on measuring TAD, inflammation, orthodontics
Eligibility Criteria
Inclusion Criteria: Good general health, with no significant medical findings 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) Miniscrew pairs indicated with comparable anatomical positions and comparable mechanics (direct vs. indirect anchorage). Exclusion Criteria: Recent or ongoing use of antiresorptive pharmacological agents contraindicating the use of orthodontic miniscrews Less than 12 years of age Heavy tobacco use (>10 cigarettes/day) Peri-implant tissues must be observable at follow-up appointments Being unable or unwilling to consent to the study
Sites / Locations
- University of Colorado School of Dental MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
K21 Cavity cleanser-coated TAD
Ethanol Control
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05639907
First Posted
November 15, 2022
Last Updated
May 10, 2023
Sponsor
University of Colorado, Denver
1. Study Identification
Unique Protocol Identification Number
NCT05639907
Brief Title
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
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 11, 2022 (Actual)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
June 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation Caused by the Placement of a Temporary Anchorage Device
Keywords
TAD, inflammation, orthodontics
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Split mouth
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
K21 Cavity cleanser-coated TAD
Arm Type
Experimental
Arm Description
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.
Arm Title
Ethanol Control
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
K21 Cavity cleanser
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Ethanol control
Intervention Description
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.
Primary Outcome Measure Information:
Title
TAD motility
Description
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.
Time Frame
8 weeks
Title
Peri-implant inflammation
Description
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.
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Good general health, with no significant medical findings
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)
Miniscrew pairs indicated with comparable anatomical positions and comparable mechanics (direct vs. indirect anchorage).
Exclusion Criteria:
Recent or ongoing use of antiresorptive pharmacological agents contraindicating the use of orthodontic miniscrews
Less than 12 years of age
Heavy tobacco use (>10 cigarettes/day)
Peri-implant tissues must be observable at follow-up appointments
Being unable or unwilling to consent to the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clifton M Carey, PhD
Phone
3037241046
Email
clifton.carey@cuanschutz.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Gerald Minick, DDS
Phone
3037247830
Email
gerald.minick@cuanschutz.edu
Facility Information:
Facility Name
University of Colorado School of Dental Medicine
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clifton Carey, PhD
Phone
303-724-1046
Email
clifton.carey@cuanschutz.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29315365
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.
Results Reference
result
PubMed Identifier
14982362
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.
Results Reference
result
PubMed Identifier
32620785
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.
Results Reference
result
PubMed Identifier
33711992
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.
Results Reference
result
PubMed Identifier
25703732
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.
Results Reference
result
Learn more about this trial
Miniscrew Stability and Peri-implant Inflammation When Precoated K21 vs Ethanol Control
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