Evaluation of Peri-implant Conditions of Orthodontic Mini Implants

Observational Study on the Peri-implant/Screw Conditions of Mini Implants Placed During Orthodontic Treatment

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.

Study Overview

• Status: Completed
• Conditions: Dental Implantation; Peri-implant Mucositis; Orthodontics; Gingival Inflammation; Implant Stability
• Intervention / Treatment: Other: Peri-implant Condition Evaluation

Detailed Description

Study Title:

Evaluation of Peri-implant Conditions of Orthodontic Mini Implants

Objective:

The primary objective of this observational study is to evaluate the periodontal conditions surrounding orthodontic mini implants placed during orthodontic treatment. Additionally, the study aims to assess the impact of existing periodontal/peri-implant conditions on the stability of the mini implants.

Background:

Orthodontic mini screws/implants are commonly used as temporary anchorage devices to prevent or reduce unwanted tooth movements during orthodontic treatment. For these mini screws to function effectively as anchorage units, they must be resistant to the forces applied and remain stable at the site of placement throughout their use. Stability is classified into two types: primary stability, which is the mechanical locking between the implant and bone immediately after placement, and secondary stability, which results from bone remodeling around the implant over time. Both types of stability are crucial for the success of mini implants.

Several factors influence the stability and success of mini implants, including the patient's age, gender, cortical bone thickness and density, the site of implant placement, mobility of surrounding tissues, 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 tissues.

Hypothesis:

The hypothesis of this study is that the incidence of gingival/mucosal inflammation around the peri-implant/mini screw areas is high.

Methodology:

Patient Population:

The study will include patients treated at Altinbas University Dental Hospital's Departments of Periodontology and Orthodontics between March 2021 and March 2023. Patients must have at least one orthodontic mini implant placed and be systemically healthy. Patients with a history of prosthetic treatment or those taking medications that affect periodontal tissues (e.g., Cyclosporine-A, Calcium Channel Blockers, Phenytoin) will be excluded.

Clinical Assessments:

Primary Assessments:

Clinical periodontal/peri-implant measurements for the entire mouth and each mini implant/screw.

Bleeding on probing (yes/no), suppuration (yes/no), mucosal redness (erythema), plaque index (0-3), gingival index (0-3), probing depth (mm), clinical attachment loss (mm), width of keratinized mucosa (mm), peri-implant mucosal thickness (mm), and radiographic evaluation of the distance between the mini implant/screw and roots (mm).

Secondary Assessments:

Stability of the mini implants/screws measured using a torque gauge. Type of orthodontic force applied, method of placement (with or without a stent), surface characteristics, type (self-tapping/self-drilling), dimensions (diameter and length), duration of application, amount of force applied (<250 grams), and type of orthodontic force system (elastic/coil systems).

Statistical Analysis:

The study will utilize descriptive statistical methods to evaluate the collected data. Due to the original nature of the research, a power analysis could not be performed before the study.

Expected Outcomes:

The findings from this study are expected to highlight the importance of soft tissue health and maintenance during the planning, surgical placement, and post-operative phases of mini implant applications in orthodontics. Additionally, the study aims to elucidate the impact of existing oral hygiene on the stability and force continuity of mini implants in similar patient groups, thereby providing insights into the optimal frequency of periodontal maintenance for individuals with mini implant anchorage.

Study Location:

Altinbas University Dental Hospital, Zuhuratbaba Neighbourhood, Incirli St. No:11-A, 34147 Bakırköy, Istanbul, Turkey.

This detailed description provides a comprehensive overview of your study, outlining its objectives, background, methodology, and expected outcomes in a structured and academic manner.

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34147
    • Altinbas University, Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Dr. Mehmet Selim Yildiz
• Investigators: Principal Investigator: Mehmet Selim YILDIZ, Asst. Prof., Altinbas University, Faculty of Dentistry

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2021
• Primary Completion (Actual): June 15, 2023
• Study Completion (Actual): September 20, 2023

Study Registration Dates

• First Submitted: June 28, 2024
• First Submitted That Met QC Criteria: July 4, 2024
• First Posted (Actual): July 9, 2024

Study Record Updates

• Last Update Posted (Actual): July 9, 2024
• Last Update Submitted That Met QC Criteria: July 4, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Infections; Gastrointestinal Diseases; Gastroenteritis; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Inflammation; Gingivitis; Mucositis
• Other Study ID Numbers: 2021/49

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Researchers can request access to the IPD by contacting Dr. Mehmet Selim Yildiz at "mehmet.yildiz2@altinbas.edu.tr"

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No