Inflammation Caused by the Placement of a Temporary Anchorage DeviceNCT05639907
Miniscrew Stability and Peri-implant Inflammation When Precoated K21 vs Ethanol Control
A study testing K21 Cavity cleanser in people with Inflammation Caused by the Placement of a Temporary Anchorage Device, run by University of Colorado, Denver at 1 site in United States.
Trial summary
To determine if coating miniscrews with K21 would increase the success rate of orthodontic miniscrews by reducing adjacent tissue inflammation. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Inflammation Caused by the Placement of a Temporary Anchorage Device
- What is being tested?
- K21 Cavity cleanser
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Nov 2022to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Colorado School of Dental Medicine
Aurora, Colorado, 80045
Clifton Carey, PhD, 303-724-1046, clifton.carey@cuanschutz.edu
About this study
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
To determine if coating miniscrews with K21 would increase the success rate of orthodontic miniscrews by reducing adjacent tissue inflammation.
Read the 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.
- Being tested
- K21 Cavity cleanser, Ethanol control
- Keywords
- TAD, inflammation, orthodontics
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
K21 Cavity cleanserDevice
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.
Ethanol controlDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: K21 Cavity cleanser |
| 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. Receives: Device: Ethanol control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2022
- Study start11 Nov 2022
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Inflammation Caused by the Placement of a Temporary Anchorage DeviceStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Split mouth
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05639907
- Sponsor's protocol ID
- 22-1579
- Status last verified
- May 2026
- First submitted
- 15 Nov 2022
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 29315365Cheng 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.
PubMed 14982362Daood 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.
PubMed 32620785Kok 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.
PubMed 33711992Meghil 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.
PubMed 25703732
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05639907
- Acronym / sponsor ID
- 22-1579
- Keywords
- TAD, inflammation, orthodontics
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 11 Nov 2022 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 7 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Split mouth
| Arm | Type | Receives |
|---|---|---|
| K21 Cavity cleanser-coated TAD | Experimental | Device: K21 Cavity cleanserA 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. |
| Ethanol Control | Placebo comparator | Device: Ethanol controlA 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. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| K21 Cavity cleanserK21 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. | Device | K21 Cavity cleanser-coated TAD |
| Ethanol controlEthanol is rinsed over the TAD and allowed to dry. The TAD is placed where needed for orthodontic therapy following the Department of Orthodontics protocols. | Device | Ethanol Control |
Primary outcome
TAD motility
Time frame: 8 weeks
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
Time frame: 8 weeks
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Results publication: PubMed 29315365Alharbi 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 publication: PubMed 14982362Cheng 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 publication: PubMed 32620785Daood 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 publication: PubMed 33711992Kok 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 publication: PubMed 25703732Meghil 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing K21 Cavity cleanser in people with Inflammation Caused by the Placement of a Temporary Anchorage Device, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clifton M Carey, PhD (3037241046, clifton.carey@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TAD motility (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05639907, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.