Ignite Creation Date:
2024-07-17 @ 10:58 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06491849
Status:
COMPLETED
Last Update Posted:
2024-07-09
First Post:
2024-06-28
Brief Title:
Evaluation of Peri-implant Conditions of Orthodontic Mini Implants
Sponsor:
Dr Mehmet Selim Yildiz
Organization:
Altinbas University
Study Overview
Official Title:
Observational Study on the Peri-implantScrew Conditions of Mini Implants Placed During Orthodontic Treatment
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients 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 gingivalmucosal inflammation and other factors that may affect implant stability and success
Factors affecting the stability and success of mini implants include the patients 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 gingivalmucosal inflammation and other factors that may affect implant stability and success
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 periodontalperi-implant conditions on the stability of the mini implants
Background
Orthodontic mini screwsimplants 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 patients 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 gingivalmucosal inflammation around the peri-implantmini screw areas is high
Methodology
Patient Population
The study will include patients treated at Altinbas University Dental Hospitals 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 eg Cyclosporine-A Calcium Channel Blockers Phenytoin will be excluded
Clinical Assessments
Primary Assessments
Clinical periodontalperi-implant measurements for the entire mouth and each mini implantscrew
Bleeding on probing yesno suppuration yesno 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 implantscrew and roots mm
Secondary Assessments
Stability of the mini implantsscrews measured using a torque gauge Type of orthodontic force applied method of placement with or without a stent surface characteristics type self-tappingself-drilling dimensions diameter and length duration of application amount of force applied 250 grams and type of orthodontic force system elasticcoil 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 No11-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
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 periodontalperi-implant conditions on the stability of the mini implants
Background
Orthodontic mini screwsimplants 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 patients 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 gingivalmucosal inflammation around the peri-implantmini screw areas is high
Methodology
Patient Population
The study will include patients treated at Altinbas University Dental Hospitals 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 eg Cyclosporine-A Calcium Channel Blockers Phenytoin will be excluded
Clinical Assessments
Primary Assessments
Clinical periodontalperi-implant measurements for the entire mouth and each mini implantscrew
Bleeding on probing yesno suppuration yesno 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 implantscrew and roots mm
Secondary Assessments
Stability of the mini implantsscrews measured using a torque gauge Type of orthodontic force applied method of placement with or without a stent surface characteristics type self-tappingself-drilling dimensions diameter and length duration of application amount of force applied 250 grams and type of orthodontic force system elasticcoil 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 No11-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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None