Evaluation of Peri-implant Conditions of Orthodontic Mini Implants

NCT06491849 | Completed

• 1 other identifier: 2021/49
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dental Implantation; Peri-implant Mucositis; Gingival Inflammation; Implant Stability; Orthodontics

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (1)

• Implant Stability

  3 months

Study Arms (1)

Orthodontic Mini Implant Group

Participants with at least one orthodontic mini implant placed for anchorage during orthodontic treatment. The study will evaluate the peri-implant conditions, including gingival and mucosal inflammation, implant stability, and other related factors.

Other: Peri-implant Condition Evaluation

Interventions

Peri-implant Condition Evaluation OTHER

This intervention involves a detailed clinical evaluation of peri-implant conditions in patients who have received orthodontic mini implants. The assessments include measuring periodontal parameters such as probing depth, bleeding on probing, mucosal redness, plaque index, gingival index, and implant stability. The evaluations are conducted at specified intervals during and after orthodontic anchorage treatment to monitor changes and ensure the health of peri-implant tissues.

Orthodontic Mini Implant Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study included patients who had been treated with orthodontic mini implants at the Department of Orthodontics, Faculty of Dentistry, Altinbas University. A total of 16 patients were included in the study.

You may qualify if:

• Participants who have at least one orthodontic mini implant placed for anchorage during orthodontic treatment.
• Systemically healthy individuals.
• Participants without a history of prosthetic treatment.

You may not qualify if:

• Individuals taking medications that can affect periodontal tissues (e.g., Cyclosporine-A, Calcium Channel Blockers, Phenytoin).
• Individuals with a history of prosthetic treatment.
• Individuals without orthodontic mini implants.

Sponsors & Collaborators

• Dr. Mehmet Selim Yildiz: lead

Study Sites (1)

Altinbas University, Faculty of Dentistry

Istanbul, 34147, Turkey (Türkiye)

Location

Related Publications (7)

• Ure DS, Oliver DR, Kim KB, Melo AC, Buschang PH. Stability changes of miniscrew implants over time. Angle Orthod. 2011 Nov;81(6):994-1000. doi: 10.2319/120810-711.1. Epub 2011 May 25.

  PMID: 21612317 BACKGROUND

• Lee SJ, Ahn SJ, Lee JW, Kim SH, Kim TW. Survival analysis of orthodontic mini-implants. Am J Orthod Dentofacial Orthop. 2010 Feb;137(2):194-9. doi: 10.1016/j.ajodo.2008.03.031.

  PMID: 20152674 BACKGROUND

• Samrit V, Kharbanda OP, Duggal R, Seith A, Malhotra V. Bone density and miniscrew stability in orthodontic patients. Aust Orthod J. 2012 Nov;28(2):204-12.

  PMID: 23304969 BACKGROUND

• Zitzmann NU, Berglundh T, Ericsson I, Lindhe J. Spontaneous progression of experimentally induced periimplantitis. J Clin Periodontol. 2004 Oct;31(10):845-9. doi: 10.1111/j.1600-051X.2004.00567.x.

  PMID: 15367187 BACKGROUND

• Park HS, Jeong SH, Kwon OW. Factors affecting the clinical success of screw implants used as orthodontic anchorage. Am J Orthod Dentofacial Orthop. 2006 Jul;130(1):18-25. doi: 10.1016/j.ajodo.2004.11.032.

  PMID: 16849067 BACKGROUND

• Parmar R, Reddy V, Reddy SK, Reddy D. Determination of soft tissue thickness at orthodontic miniscrew placement sites using ultrasonography for customizing screw selection. Am J Orthod Dentofacial Orthop. 2016 Oct;150(4):651-658. doi: 10.1016/j.ajodo.2016.03.026.

  PMID: 27692423 BACKGROUND

• Yildiz MS, Ulutas PA, Ozenci I, Akcali A. Clinical and radiographic assessment of the association between orthodontic mini-screws and periodontal health. BMC Oral Health. 2024 Nov 14;24(1):1376. doi: 10.1186/s12903-024-05136-2.

  PMID: 39543578 DERIVED

MeSH Terms

Conditions

Gingivitis

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Mehmet Selim Yildiz, Asst. Prof.

  Altinbas University, Faculty of Dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor, Dr.

Study Record Dates

• First Submitted: June 28, 2024
• First Posted: July 9, 2024
• Study Start: March 4, 2021
• Primary Completion: June 15, 2023
• Study Completion: September 20, 2023
• Last Updated: July 9, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)