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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06132906
Other study ID # orthognathicalexu
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 15, 2022
Est. completion date November 1, 2023

Study information

Verified date November 2023
Source Alexandria University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

clinical and radiographic comparison between novel locating guide design with pre-bent titanium plates and 3d printed intermediate wafer to reposition the maxilla after Le Fort 1 osteotomy in orthognathic surgery (randomized controlled clinical trial)


Description:

Eligible patients will be allocated randomly into 2 equal groups with 7 patients in each group according to the method that will be used to reposition the maxilla by simple randomization using computer generated random numbers. Group 1 (Study group) will be treated with locating guides to reposition the maxilla with pre-bent plates on 3d model. Group 2 (Control group) will be treated with Intermediate wafer.


Recruitment information / eligibility

Status Completed
Enrollment 14
Est. completion date November 1, 2023
Est. primary completion date October 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 42 Years
Eligibility Inclusion Criteria: - All patients requiring Le Fort I osteotomy will be selected including those suffering from skeletal malocclusion (Class II or Class III), midface hypoplasia or vertical maxillary excess. Exclusion Criteria: cleft lip and palate. skeletal disharmony due to trauma or severe facial asymmetry. significant medical condition.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Orthognathic surgery (lefort1)
All patients will be treated under general anesthesia. The surgical field will be scrubbed with povidone-iodine surgical scrub solution, followed by draping of the patient with sterile towels exposing only the area of surgery. The surgical procedure of Le Fort I osteotomy will be performed which can be summarized as follows: External reference marking Incision and subperiosteal dissection Maxillary osteotomy Pterygomaxillary disjunction, Septal, vomerine, and lateral nasal osteotomies Down fracture Mobilization of the maxilla Application of stent in one group and the locating guide in the other group. Maxillary fixation Occlusal evaluation Wound debridement and closure

Locations

Country Name City State
Egypt Alexandria University, Faculty of dentistry Alexandria

Sponsors (1)

Lead Sponsor Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Radiographic evaluation of accuracy by superimposition Postoperative CBCT was obtained after 2 weeks of surgery for comparison with the expected position of the maxilla in the preoperative virtual plan using 3-matic software in Mimics innovation suite software package. The preoperative planned final maxillary position was compared with the actual postoperative maxillary position by superimposing both STL models on each other with anatomical points along the orbital rims and the zygomatic arch used as reference points for alignment. The N points registration tool was used to obtain the alignment. Afterwards, using trim tool all parts were trimmed except that between the plates and the maxillary teeth crowns. Then the part comparison analysis tool was used to calculate the accuracy of the superimposition of the maxillary segment using point-based analysis algorithm after 2 weeks of surgery for comparison with the expected position of the maxilla in the preoperative virtual plan using Mimics innovation suite software. 2 weeks
Primary The surgery duration The time taken between performing the Le fort 1 osteotomy till completion of plate fixation will be measured. 1 week
Secondary Postoperative Pain Will be assessed through a 10-point Visual Analogue Scale (VAS) after one week, two weeks
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