Clinical trial NCT06786221: Accuracy, Stability and Safety of Orthodontic Mini-implant Template in the Infrazygomatic Crest Zone
Official title: Accuracy, Stability and Safety of Orthodontic Mini-implant Template in the Infrazygomatic Crest Zone
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Dental Implants
Dental Implantation
Lead sponsor: Universiti Sains Malaysia
Sponsor class: OTHER
First posted: 2025-01-22
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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. The orthodontic clinical design should include the use of miniscrews for anchorage requirements in maxillary arch.
2. Age of 18-35 years old
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.

Exclusion criteria

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

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:

1. To compare the accuracy of miniscrews implanted using modified template by computer-aided design and without template guide (conventional method).
2. To compare the stability of miniscrews implanted using modified template by computer-aided design and without templete guide (conventional method).
3. To compare the safety of miniscrews implanted using modified template by computer-aided design and without templete guide (conventional method).

Participants will:

1. The patient undergoes routine pre-orthodontic examination, model analysis, cephalometric measurement, and develops an orthodontic treatment plan.
2. .The patient undergoes routine pre-orthodontic examination, model analysis, cephalometric measurement, and develops an orthodontic treatment plan.
3. 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.
4. 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.

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)


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Accuracy of Implant Placement
timeFrame: up to 6 months
measure: Stability of Implant
timeFrame: up to 6 months
measure: Safety and Adverse Events
timeFrame: up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Xuanwu Tcm Hospital
state: Beiijng
Study officials:
affiliation: Universiti Sains Malaysia
name: Norma Ab Rahman, phd
role: STUDY_DIRECTOR
References: