Accuracy, Stability and Safety of Orthodontic Mini-implant Template in the Infrazygomatic Crest Zone

NCT06786221 | Active Not Recruiting DMC

• 2 other identifiers: Beijing Xuanwu Tcm HospitalXWKX2024-32
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn accuracy, stability and safety of orthodontic mini-implant template in the infrazygomatic crest zone.References population isOrthodontics patients which is require to implant miniscrew as anchorage requirement .Inclusion criteria

1. 1.The orthodontic clinical design should include the use of miniscrews for anchorage requirements in maxillary arch.
2. 2.Age of 18-35 years old
3. 3.Patients must have no prior history of orthodontic treatment and must have a healthy periodontal condition or no history of trauma before the current orthodontic treatment.
4. 4.Patient with poor oral hygiene, history of systemic diseases and metal allergies;
5. 5.Patients with osteoporosis and inability to retain the TAD;
6. 6.Patients who require orthognathic surgery for severe skeletal malocclusion;
7. 7.Smoking patients which will affect the success rate of the implant placement
8. 8.Patients with incomplete medical records.
9. 9.To compare the accuracy of miniscrews implanted using modified template by computer-aided design and without template guide (conventional method).
10. 10.To compare the stability of miniscrews implanted using modified template by computer-aided design and without templete guide (conventional method).
11. 11.To compare the safety of miniscrews implanted using modified template by computer-aided design and without templete guide (conventional method).
12. 12.The patient undergoes routine pre-orthodontic examination, model analysis, cephalometric measurement, and develops an orthodontic treatment plan.
13. 13..The patient undergoes routine pre-orthodontic examination, model analysis, cephalometric measurement, and develops an orthodontic treatment plan.
14. 14.The process of insertion of miniscrew will be depend on the group either Intervention Group or Control Group. The guide plate will be used for miniscrew insertion in Intervention Group and experience based on the patient's digital films for Control Group. The area of insertion of the miniscew will be the upper alveolar ridge between premolars and molar tooth. The procedure will be performed under local injection anesthesia.
15. 15.The process of implanting implant nails on Intervention Group is as follows: the material and model of the implanted micro implant nails are exactly the same as those of the traditional positioning set. The implant nail diameter is 2mm and the length is 10 mm. The implant surgery was performed by the same orthodontist in accordance with recommended operating procedures. Preoperative local anesthesia will be performed, and micro-implant nails will be implanted at the intended implantation site under the guidance of the guide plate. The area of implantation is maxillary zygomatic alveolar ridge.

Conditions

Dental Implants; Dental Implantation

Outcome Measures

Primary Outcomes (3)

• Accuracy of Implant Placement

  The primary goal is to assess the accuracy of implant placement using the orthodontic mini-implant template in the infrazygomatic crest zone. This will be measured by comparing the planned implant position (based on preoperative imaging) with the actual implant position achieved during surgery.

  up to 6 months

• Stability of Implant

  The stability of the mini-implants will be assessed to ensure they remain securely in place during the orthodontic treatment period.

  up to 6 months

• Safety and Adverse Events

  e safety of the mini-implant template will be evaluated by recording any adverse events or complications related to the implant surgery or the use of the template.

  up to 6 months

Study Arms (2)

mini-implant template

EXPERIMENTAL

Participants in this arm will undergo micro-implant surgery using a digitally designed and 3D-printed micro-implant guide template. Details: The guide template is created based on preoperative CT scans of the participant's anatomy. The template is used during the surgery to precisely guide the placement of micro-implants in terms of position, angle, and depth. The surgery is performed with the assistance of the digital guide to ensure accuracy and reduce the risk of complications. Data on the stability of the guide, implant accuracy, and surgical time are recorded.

Device: mini-implant template

Control Group

NO INTERVENTION

Participants in this arm will undergo traditional freehand micro-implant surgery without the use of any guide template or digital assistance. Details: The surgery relies entirely on the surgeon's experience and manual operation. No digital or physical guides are used during the procedure. Data on surgical time, implant accuracy, and any post-operative complications are recorded. This arm serves as the control group to compare the outcomes with those of the experimental group.

Interventions

mini-implant template DEVICE

The proposed structure will be made of three main components: a tooth guide part, a gingival guide part, and a steering part. The tooth guide and gingival guide parts are firmly connected by fracture lines. The mini-implant guide part is specifically designed to accommodate the angle and position required for miniscrew insertion. On the basis of the resin guide plate, add a guide hole structure and change it to simulate the patient's actual tooth root condition. During usage, the guide can be pre-designed in accordance with the desired planting position and direction of the patient's mini-implant, enabling precise guidance during the implantation process. The designed guide's data is inputted into EnvisionTEC Vida 3D printer to create the mini-implant guide. Prior to the implantation of the mini-screw, patients will be informed about the potential risks and required to sign an informed consent form.

mini-implant template

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• The orthodontic clinical design should include the use of miniscrews for anchorage requirements in maxillary arch.
• Age of 18-35 years old.
• Patients must have no prior history of orthodontic treatment and must have a healthy periodontal condition or no history of trauma before the current orthodontic treatment.

You may not qualify if:

• Patient with poor oral hygiene, history of systemic diseases and metal allergies.
• Patients with osteoporosis and inability to retain the TAD.
• Patients who require orthognathic surgery for severe skeletal malocclusion.
• Smoking patients which will affect the success rate of the implant placement.
• Patients with incomplete medical records.

Sponsors & Collaborators

• Universiti Sains Malaysia: lead

Study Sites (1)

Beijing Xuanwu Tcm Hospital

Beijing, Beiijng, 100000, China

Location

Study Officials

• Norma Ab Rahman, phd

  Universiti Sains Malaysia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: phd

Study Record Dates

• First Submitted: November 20, 2024
• First Posted: January 22, 2025
• Study Start: July 24, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 22, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)