Evaluation of Peri-implant Conditions of Orthodontic Mini Implants
NCT Number: NCT06491849
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Dental Implantation|Peri-implant Mucositis|Gingival Inflammation|Implant Stability|Orthodontics
Interventions: OTHER: Peri-implant Condition Evaluation
Sponsor: Dr. Mehmet Selim Yildiz
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Observational Model: |Time Perspective: p
Start Date: 2021-03-04
Completion Date: 2023-09-20
Locations: Altinbas University, Faculty of Dentistry, Istanbul, 34147, Turkey

Summary:
This observational study aims to evaluate the peri-implant conditions of mini implants placed during orthodontic treatment. Orthodontic mini implants are commonly used as temporary anchorage devices to prevent or reduce unwanted tooth movements during orthodontic treatment. The stability of these implants, both primary and secondary, is crucial for their success. Primary stability refers to the mechanical locking between the implant and bone immediately after placement, while secondary stability is achieved through bone remodeling around the implant over time.

Factors affecting the stability and success of mini implants include the patient's age, gender, cortical bone thickness and density, the site of implant placement, the presence of mobile surrounding tissue, implant dimensions, surface characteristics, and the magnitude and duration of applied orthodontic forces. Peri-implantitis, an inflammation around the implant, is a significant risk factor for implant failure and is influenced by oral hygiene and the quality of surrounding soft tissue.

This study will observe and analyze the peri-implant conditions in patients receiving orthodontic treatment with mini implants, focusing on the incidence of gingival/mucosal inflammation and other factors that may affect implant stability and success.

Primary Outcome Measures: Gingival/Mucosal Inflammation, Measurement of gingival and mucosal inflammation around the orthodontic mini implants using clinical indices. Units of Measure:

Gingival Index (GI) (0-3) Plaque Index (PI) (0-3), 3 months|Probing Pocket/Mucosal Depth, Measurement of the depth of periodontal pockets or mucosal depth around the mini implants. Unit of Measure: Millimeters (mm), 3 months|Clinical Attachment Loss (Gingival recession), Measurement of the loss of attachment or gingival recession in the periodontal tissues and around the mini implants. Unit of Measure: Millimeters (mm), 3 months|Width of Keratinized Mucosa, Measurement of the width of keratinized mucosa around the mini implants. Unit of Measure: Millimeters (mm), 3 months|Thickness of Peri-Implant/Screw Mucosa, Measurement of the thickness of the mucosa around the mini implants. Unit of Measure: Thick/Thin, 3 months|Radiographic Evaluation, Measurement of the distance between the mini implant/screw and adjacent roots. Unit of Measure: Millimeters (mm), 3 months|Bleeding on Probing, Assessment of the presence or absence of bleeding upon probing around the mini implants and teeth. Unit of Measure: Binary (Yes/No) and given as percentage by the site and full mouth., 3 months|Mucosal redness (Erythema), Assessment of the presence and degree of mucosal redness around the mini implants.

Unit of Measure: Binary (Yes/No), 3 months|Mucosal discomfort, Patient-reported discomfort in the area surrounding the mini implants. Unit of Measure: Binary (Yes/No), 3 months
Secondary Outcome Measures: Implant Stability, Assessment of the stability of the orthodontic mini implants using a torque gauge to measure insertion and removal torque values. Unit of Measure: Torque (Ncm), 3 months