NCT07662434

Brief Summary

Primary goal of this study to check the stability of miniscrews used in orthodontic treatment in order to evaluate the success of the treatment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 20, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 2, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 2, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 11, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 23, 2026

Completed
Last Updated

June 23, 2026

Status Verified

June 1, 2026

Enrollment Period

1.3 years

First QC Date

June 11, 2026

Last Update Submit

June 19, 2026

Conditions

Keywords

MiniscrewsAcid-etched Miniscrews

Outcome Measures

Primary Outcomes (1)

  • Primary Stability of of machined and acid-etched miniscrews

    Absence of clinical stability of miniscrews (\>1mm)

    After one month of insertion

Study Arms (2)

experimental group: Acid etcehd miniscrews

EXPERIMENTAL

Placement of surface treated screws

Device: miniscrews placement

Control Group with conventional miniscrews

PLACEBO COMPARATOR

Non-surface treated miniscrews

Device: miniscrews placement

Interventions

Placement of miniscrews under local anesthesia in both groups

Control Group with conventional miniscrewsexperimental group: Acid etcehd miniscrews

Eligibility Criteria

Age13 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Fixed appliance treatment with or without premolar extraction One or more miniscrews for same reason in each quadrant of maxilla or mandible Patient over 13 years Patient with permanent dentition\\ Treatment plan should include miniscrews

You may not qualify if:

  • Severe craniofacial deformities such as cleft lip and palate History of bone disease Cases with high expectation of failure due to anatomical limitation such as sinus pneumatization Narrow interproximal alveolar bone Attached gingiva deficiency Mixed Dentition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foundation University College of Dentistry and Hospital

Islamabad, Federal, 44000, Pakistan

Location

Related Publications (6)

  • Yoo SH, Park YC, Hwang CJ, Kim JY, Choi EH, Cha JY. A comparison of tapered and cylindrical miniscrew stability. Eur J Orthod. 2014 Oct;36(5):557-62. doi: 10.1093/ejo/cjt092. Epub 2013 Dec 19.

  • Chen YJ, Chang HH, Huang CY, Hung HC, Lai EH, Yao CC. A retrospective analysis of the failure rate of three different orthodontic skeletal anchorage systems. Clin Oral Implants Res. 2007 Dec;18(6):768-75. doi: 10.1111/j.1600-0501.2007.01405.x. Epub 2007 Sep 14.

  • Chang C, Liu SS, Roberts WE. Primary failure rate for 1680 extra-alveolar mandibular buccal shelf mini-screws placed in movable mucosa or attached gingiva. Angle Orthod. 2015 Nov;85(6):905-10. doi: 10.2319/092714.695.1. Epub 2015 Jan 20.

  • Choi SH, Jang SH, Cha JY, Hwang CJ. Evaluation of the surface characteristics of anodic oxidized miniscrews and their impact on biomechanical stability: An experimental study in beagle dogs. Am J Orthod Dentofacial Orthop. 2016 Jan;149(1):31-8. doi: 10.1016/j.ajodo.2015.06.020.

  • Gansukh O, Jeong JW, Kim JW, Lee JH, Kim TW. Mechanical and Histological Effects of Resorbable Blasting Media Surface Treatment on the Initial Stability of Orthodontic Mini-Implants. Biomed Res Int. 2016;2016:7520959. doi: 10.1155/2016/7520959. Epub 2016 Jan 28.

  • Park HJ, Choi SH, Choi YJ, Park YB, Kim KM, Yu HS. A prospective, split-mouth, clinical study of orthodontic titanium miniscrews with machined and acid-etched surfaces. Angle Orthod. 2019 May;89(3):411-417. doi: 10.2319/031618-211.1. Epub 2018 Dec 5.

MeSH Terms

Conditions

Crowding

Condition Hierarchy (Ancestors)

Spatial BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 11, 2026

First Posted

June 23, 2026

Study Start

June 20, 2024

Primary Completion

October 2, 2025

Study Completion

December 2, 2025

Last Updated

June 23, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Patient privacy

Locations