Evaluation of a custom 3D surgical guide in mandibular sagittal split osteotomy

ISRCTN	ISRCTN35139147
DOI	https://doi.org/10.1186/ISRCTN35139147
Sponsor	University of Indonesia
Funder	Direktorat Riset and Pengembangan, Universitas Indonesia

Submission date: 29/12/2025
Registration date: 31/12/2025
Last edited: 30/12/2025

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Oral Health

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Plain English summary of protocol not provided at time of registration.

Contact information

Mrs Evy Eida Vitria
Public, Scientific, Principal investigator

Oral and Maxillofacial Surgery, Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, University of Indonesia
Jakarta
10430
Indonesia

ORCID ID	0000-0003-1082-8672
Phone	+62 08159521678
Email	evyeida2020@gmail.com

Mr Muhammad Kamil Hassan
Public, Scientific, Principal investigator

Department of Oral and Maxillofacial Clinical Sciences, Universiti Malaya
Kuala Lumpur
50603
Malaysia

Phone	+60174707510
Email	kamil.hassank@um.edu.my

Mrs Revini Nuita
Scientific

Grand Parahyangan Estate Cluster Handeleum Nomor 20 Bogor
Kota Bogor
16155
Indonesia

ORCID ID	0000-0003-4679-0100
Phone	+62 087886521172
Email	drg.revininuita@gmail.com

Mrs Nissia Ananda
Scientific, Principal investigator

Jalan Florida Raya 01/10, Kota Wisata
Cibubur
13720
Indonesia

Phone	+62 081314165554
Email	01nissia@gmail.com

Study information

Primary study design	Interventional
Allocation	Randomized controlled trial
Masking	Blinded (masking used)
Control	Active
Assignment	Crossover
Purpose	Basic science
Scientific title	Patients undergoing mandibular sagittal split osteotomy: comparison of custom three-dimensional surgical guide versus conventional technique on lingual split pattern, lateral osteotomy end, and inferior alveolar nerve exposure — a split-mouth randomized controlled trial
Study objectives	The primary objective of this study is to evaluate the effect of a customized 3D-printed surgical guide on split pattern characteristics during bilateral sagittal split osteotomy (BSSO) of the mandible. Specifically, this randomized controlled trial aims to compare lingual split patterns, lateral osteotomy end position, and inferior alveolar nerve exposure between mandibular sides operated with and without the use of a custom 3D surgical guide within the same patient.
Ethics approval(s)	Approved 31/05/2025, Dental Research Ethics Committee, Faculty of Dentistry, Universitas Indonesia (Jln. Salemba Raya No. 4 Jakarta Pusat, Jakarta, 10430, Indonesia; +(62-21) 31906289; etikrisetfkg@ui.ac.id), ref: 78/Ethical Approval /FKGUI/V/2025
Health condition(s) or problem(s) studied	Correction of dentofacial deformities in adult patients with skeletal Class II or Class III mandibular discrepancies undergoing bilateral sagittal split osteotom
Intervention	The intervention consisted of a custom 3D-printed surgical cutting guide–assisted mandibular sagittal split osteotomy (BSSO). It was developed to improve osteotomy accuracy and control split patterns by translating virtual surgical planning into precise intraoperative guidance, reducing unfavorable splits and variability associated with freehand techniques. Patient-specific acrylic cutting guides were fabricated using 3D printing based on cone-beam CT or multislice CT imaging and virtual planning software (3D Slicer, Meshmixer, Blender). Preoperative CT data were segmented to create a 3D mandibular model, and osteotomy lines were virtually planned following the Obwegeser–Dal Pont–Hunsuck–Epker modification. During surgery, the guide was positioned intraorally and secured with miniscrews to guide medial and lateral osteotomies. The procedure was performed face-to-face under general anesthesia during a single orthognathic surgery session, applied individually to each mandibular side according to split-mouth randomization. All surgeries were carried out by board-certified Oral and Maxillofacial Surgeons experienced in orthognathic surgery, supported by radiologists and biomedical engineers trained in virtual surgical planning and CAD/CAM workflows. The intervention took place in operating theatres at Universitas Indonesia Hospital and Universiti Malaya Medical Centre, equipped with standard orthognathic surgical and digital planning infrastructure. Each surgical guide was tailored to the patient’s anatomy and osteotomy trajectory based on preoperative imaging. No modifications to the protocol were made during the study. Fidelity was ensured through adherence to a standardized digital planning and guide fabrication protocol, with intraoperative verification of guide fit and stability. All guides were successfully positioned and used as planned, with no intraoperative fractures or failures reported.
Intervention type	Procedure/Surgery
Primary outcome measure(s)	Lingual split patterns measured using three-dimensional mandibular models reconstructed from CT scans at 2 weeks postoperatively
Key secondary outcome measure(s)	Lateral Osteotomy End (LOE) position measured using axial CT images and 3D virtual mandibular models at 2 weeks postoperatively Inferior alveolar nerve exposure measured using the nerve exposure scale of Lee et al. (2016): NE1: No visible nerve exposure, NE2: Partial nerve exposure within the distal segment, and NE3: Complete nerve exposure detached from the distal segment at the intraoperative assessment
Completion date	15/12/2025

Eligibility

Participant type(s)
Age group	Mixed
Lower age limit	18 Years
Upper age limit	80 Years
Sex	All
Target sample size at registration	16
Total final enrolment	30
Key inclusion criteria	1. Age ≥18 years 2. Mandibular skeletal Class II or Class III deformities 3. Signed informed consent
Key exclusion criteria	1. Non-SSO orthognathic procedures 2. Medically compromised patients 3. Refusal to sign the informed consent
Date of first enrolment	01/05/2024
Date of final enrolment	15/12/2025

Locations

Countries of recruitment

Indonesia
Malaysia

Study participating centres

University of Indonesia

Jl. Prof. DR. Bahder Djohan, Pondok Cina, Kecamatan Beji, Kota Depok, Jawa Barat 16424
DKI Jakarta
Indonesia

Universiti Malaya

Lembah Pantai, 59100. Kuala Lumpur, Malaysia
kuala lumpur
Malaysia

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Published as a supplement to the results publication
IPD sharing plan	The datasets generated and/or analysed during the current study will be published as a supplement to the results publication

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Other files			30/12/2025	No	No

Additional files

48750_TIDieR Checklist for the Custom 3D Surgical Guide Intervention.pdf: Other files

Editorial Notes

30/12/2025: Study’s existence confirmed by the Dental Research Ethics Committee, Faculty of Dentistry, Universitas Indonesia.