Miniscrew Stability and Peri-implant Inflammation When Precoated K21 vs Ethanol Control

Conditions

• Inflammation Caused by the Placement of a Temporary Anchorage Device

Eligibility Criteria

Sex

ALL

Age

12 Years - N/A

Healthy Volunteers

Accepted

Interventions

• 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.
• 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.

Study Details

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

Key Dates

Start date

Nov 11, 2022

Status verified

May 2026

Primary completion

Jun 30, 2028

Completion

Jun 30, 2028

Study Design

Enrollment

30 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Experimental: K21 Cavity cleanser-coated TAD
  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.
• Placebo Comparator: Ethanol Control
  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.

Primary Outcome Measure

TAD motility [ Time Frame: 8 weeks ]

Central Contacts

• Clifton M Carey, PhD
  3037241046
  [email protected]
• Gerald Minick, DDS
  3037247830
  [email protected]

Locations (1)

Find similar trials in Aurora, CO