Clinical trial NCT05822271: Evaluation of Surgical Outcomes of Patients Treated With the Surgery First Approach and Aligners
Official title: Evaluation of Surgical Outcomes of Patients Treated With the Surgery First Approach and Aligners
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Malocclusion, Angle Class III
Keywords: Surgery-First
Orthognathic
Aligner
Aesthetic Treatment
Lead sponsor: Rio de Janeiro State University
Sponsor class: OTHER
First posted: 2023-04-20
Enrollment: 20
Sex: ALL
Minimum age (years): 17
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this prospective study is to compare treatment outcomes and the quality of life of skeletal Class III patients treated with conventional fixed appliances and aligners undergoing Surgery-first approach. Data will be collected through validated questionnaires: OQLQ (Orthognathic Quality of Life Questionnaire), OHIP-14 (Oral Health Impact Proﬁle), SF-36 (Medical Outcomes Study 36 - Item Short-Form Health Survey) and IOTN (Index of Orthodontic Treatment Need).


Eligibility criteria: Inclusion Criteria:

* Adults;
* Skeletal malocclusion;
* ANB Angle zero or negative;
* Witts negative;
* Etiology: mandibular excess, a maxillary deficiency, or a combination of both;
* Indication for bimaxillary surgery;

Exclusion Criteria:

* Previous orthodontic treatment;
* Craniofacial anomaly or previous fracture of the facial bones;
* Total edentulism;
* Deep curve of Spee;
* Vertical asymmetry;
* Any medication use that contraindicates surgical treatment.

Primary outcomes:
measure: Quality of life accessed by validated questionnaires.
timeFrame: at the end of orthodontic treatment (up to 2 years).
Secondary outcomes:
measure: Periodontal status.
timeFrame: at the end of orthodontic treatment (up to 2 years).
measure: Treatment duration.
timeFrame: at the end of orthodontic treatment (up to 2 years).
measure: Facial changes as measured by tomographic superimposition of the face.
timeFrame: at the end of orthodontic treatment (up to 2 years).
measure: Incisors inclination
timeFrame: at the end of orthodontic treatment (up to 2 years).
measure: Alveolar bone changes around incisors.
timeFrame: at the end of orthodontic treatment (up to 2 years).
measure: Swelling as measured by tomographic images.
timeFrame: 12 months post-operative.
measure: Surgery stability as measured by tomographic superimposition.
timeFrame: 12 months post-operative.
measure: Changes in relationship between maxilla and mandible as measured by tomographic superimposition of the cranial base.
timeFrame: 12 months post-operative.
Other outcomes:
Locations:
city: Rio De Janeiro
country: Brazil
facility: Rio de Janeiro State University
Study officials:
References:
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citation: de Leyva P, Eslava JM, Hernandez-Alfaro F, Acero J. Orthognathic surgery and aligners. A comparative assessment of periodontal health and quality of life in postsurgical orthodontic treatment with aligners versus traditional fixed appliances: a randomized controlled trial. Med Oral Patol Oral Cir Bucal. 2023 May 1;28(3):e208-e216. doi: 10.4317/medoral.25555.