Miniscrew Stability and Peri-implant Inflammation with K21 vs Ethanol
This study is looking at whether a product called K21 Cavity cleanser can help orthodontic miniscrews (small screws placed in bone to help move teeth) stay stable and reduce inflammation around them. Researchers will compare K21 to ethanol, which is used as a control. You might be able to join if you are 12 years or older, in good general health, and need at least two miniscrews for your orthodontic treatment. The study will consider the treatment successful if the miniscrews remain stable for 8 weeks and if there is less inflammation. The current recruitment status is unclear.
- Study design
- This is an interventional study planning to enroll 30 participants. It uses a "split mouth" design, meaning each participant will receive both K21 and ethanol treatments.
- What's involved
- You will have miniscrews placed, with one treated with K21 and another with ethanol. Your miniscrew stability and inflammation will be checked at 4 and 8 weeks after placement.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 8 weeks after miniscrew placement to assess stability and inflammation.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Miniscrew Stability and Peri-implant Inflammation When Precoated K21 vs Ethanol Control
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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What this trial measures
- TAD motility8 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 inflammation8 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.