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| ID | Type | Description | Link |
|---|---|---|---|
| XWKX2024-32 | Other Grant/Funding Number | Beijing Xicheng District Health Commission |
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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
Exclusion criteria
The main questions it aims to answer are:
The general objective of this research is to study the effect of utilizing modified miniscrew template as tools for the miniscrew placement.
Specific Objective
The specific objectives for this study will be:
Participants will:
5)The process of implanting implant nails on the Control Group is as follows: Similar to the intervention group, but the doctor implant the miniscrew based on experience with CBCT scans.
6) Collect date before and after implant nail implantation.The digital plaster models will be obtained by scanning with a D700 scanner (3shape, Denmark). Both digital models and CBCT scan data will be imported into Segma implant guide software (Beijing, China). The combination method is as follows: first, open the file in a way that only uses CBCT for implant design and adjust the density of anatomical landmarks such as the maxillary sinus, condylar foramen, or protrusions to an explicit level. Then, the teeth or jaw landmark points of the model and CBCT will be selected to reconstruct a 3D model.
4)The data collection will be performed by obtaining plaster model using intaoral scanner at T1(immediate post insertion) and T2 (6 months post insertion)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Norma Ab Rahman, phd | Universiti Sains Malaysia | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Xuanwu Tcm Hospital | Beijing | Beiijng | 100000 | China |
There is no plan to make individual participant data (IPD) available to other researchers.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 1, 2024 | Jan 14, 2025 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 1, 2024 | Jan 14, 2025 | ICF_001.pdf |
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