Surgery-first orthognathic approach: A “scoping review” for mapping outcomes and plausible recommendations to develop core outcome sets
Aims and ObjectivesThe aim of this scoping review was to identify the type of outcomes measured in surgery- first orthognathic approach (SFOA). The objectives were to classify the outcomes into predetermined domains and explore the degree of representation of each domain. Furthermore, to identify which domains are over- or under-represented and determine whether the findings of this scoping review could be employed to provide a template for core outcome sets (COS). Five outcomes were identified, and all the research pertinent to SFOA were assigned to these outcomes.
Materials and MethodsElectronic databases and additional records were searched from January 2009 to March 2019 to source the data, and 525 records were identified.
ResultsThe initial database and additional search resulted in 525 records, of which 54 potentially relevant articles were retrieved in full. 35 studies met the selection criteria following screening and were included in the scoping review with the results of the search depicted in the preferred reporting items for systematic reviews and meta-analyses. Domains such as morphological features or changes in maxillofacial skeleton and occlusion (n = 25, 71.42%) and psychosocial well-being including quality of life outcome (n = 8, 22.85%) were well represented while functional status (n = 1, 2.85%), health resource utilization (n = 0), and adverse effects (n = 1, 2.85 %) were under-represented.
ConclusionsLimited research on SFOA precludes development of COS. However, future SFOA clinical trials should consider underrepresented outcome domains to address the SFOA treatment modality comprehensively.
A “scoping review” is a relatively new but increasingly becoming a popular research synthesizing approach. A scoping review plays an important role in mapping an existing literature on a subject or a topic or a field of interest that is not extensively reviewed or is of a complex in nature.[1-3] The basic premise of scoping review is to establish a groundwork on which an extensive research, such as full systematic review, could be carried out. Furthermore, scoping review provides a robust and transparent method to identify research gaps in the existing literature pertaining to the specific topic and act as a preliminary step to a more comprehensive systematic review.[5,6] Surgery-first orthognathic approach (SFOA) is an emerging sub-discipline of orthodontics-orthognathic jaw surgery domain whose roots can be traced back to 1960s, when Skaggs JE promulgated that, to achieve adequate interarch relationship, orthognathic jaw surgery should commence before orthodontic treatment. Since then, a surfeit of SFOA treatment protocols is aimed at (1) reduction of total treatment time, (2) accelerating post- operative orthodontic tooth movement, (3) improving patient satisfaction rate, and (4) enhancing health-related quality of life (HRQoL).[8-14,15] Recent review on SFOA outcome shows that the researchers have placed emphasis on assessing morphological features of maxillofacial skeleton and occlusion, reduction in total treatment time, and patient or practitioners satisfaction level. However, there is no uniform consensus on which outcomes of SFOA needs to be analyzed to identify the potential benefits and pitfalls of SFOA or whether there is an impetus to develop an overall core outcome sets (COS) for clinical trials of SFOA to overcome or significantly reduce heterogeneity amongst SFOA studies and minimize outcome reporting bias. Development of COS is one such robust tool that can aid to standardize outcomes for clinical trials and systematic reviews to overcome the aforementioned limitations. Outcome measures in rheumatology and harmonizing outcome measures for eczema are some of the initiatives that are undertaken, in medicine, to improve endpoint outcome measurement through a data-driven, iterative alignment process.[17-19]
MATERIALS AND METHODS
A scoping review of the literature was carried out with the analytic framework using the methodology described by Arksey and O’Malley. The literature search, scope, and reporting of findings were focused with the following stages:
Framework Stage 1: Identifying the research question.
Framework Stage 2: Identifying relevant studies.
Framework Stage 3: Study selection.
Framework Stage 4: Charting the data.
Framework Stage 5: Collating, summarizing, and reporting the results.
Framework Stage 1: identifying the research question
We formulated our primary research question: What are the types of outcomes measured in SFOA? This scoping review was undertaken with the following aims; (1) to identify the type of outcomes measured in SFOA; (2) to categorize the outcomes into predetermined domains; (3) to explore the extent of representation of each domain to identify which domains have been over- or under-represented; and (4) to determine whether the findings of this scoping review could be employed in providing a template for COS that should be measured in all future clinical trials involving SFOA.
Framework Stage 2: identifying relevant studies, and framework Stage 3: study selection
Reviews suitable for the central research question of this scoping review was carried out by adopting a comprehensive search strategy that involved searching different sources such as, electronic databases, reference lists, manual searching of key journals, existing networks, relevant organizations, and conferences. The scoping reviews study selection criteria are enumerated in Table 1.
|Inclusion criteria||Exclusion criteria|
|All types of studies pertaining to SFOA||Case reports and studies with less than five participants|
|All age groups, nonsyndromic individuals with skeletal maxillofacial deformity||Personal opinions|
|Individuals treated with minimum or no presurgical orthodontic interventions||Nonhuman study|
|Any types of comparison with conventional orthognathic jaw surgery||Modified surgery with no surgery done immediatelyor within 1 month after orthodontic treatment|
|All types of reported outcomes||Technique article|
SFOA: surgery-first orthognathic approach
Electronic databases: The following electronic databases were searched from January 2009 to March 2019 without restrictions to language. The start date of 2009 was chosen because the case report by Nagasaka et al. published in 2009 is often cited as the first clinical application of SFOA, and subsequently, numerous research papers have been published with reference to surgery-first protocol.[8-11,20]
PubMed (www.ncbi.nlm.nih.gov/pubmed/), Cochrane Library Databases, MEDLINE via OVID, EMBASE via OVID, Literatura Latino Americana em Ciências da Saúde, ClinicalTrials.gov., Australian New Zealand clinical trials registry (http://www.anzctr.org.au/), Australian clinical trials (www.australianclinicaltrials.gov.au/search/node/), and Google Scholar were searched with following term sequence: (“surgery first OR surgery early”) AND (“orthognathic surgery”) OR (“surgery first”) AND (“orthodontics” [MeSH]). The term “modified surgery” was excluded from the search strategy and further during the full texts article assessment for eligibility, as it did not satisfy the true meaning of performing surgery-first without orthodontics or minimal orthodontics (i.e. placing only brackets and wires immediately or 1 month before orthognathic surgery).
Framework Stage 4: charting the data
The data extracted from the eligible studies were recorded with information of the first author, year of publication, and study characteristics. The specific information of the eligible studies was charted according to the PICO guidelines with enumeration of study design, participants, intervention, comparison, outcome (primary and secondary), method of measurement, and also outcome domain [Table 2]. Studies that were excluded from the review are shown in Table 3 with reasons for exclusion.
|Authors/Year||Study design||Participant||Intervention||Comparison||Outcome primary/Secondary||Method of measurement||Outcome domain|
|Liao et al./2010||Retrospective study||33 pts, Conventional jaw surgery (n, 13; 21.0±4.0 years) and SFOA (n, 20; 23.0±4.0 years||SFOA in skeletal class III open bite||Conventional surgery in skeletal class III open bite||Facial aesthetics, occlusion, stability, and efficiency||Lateral cephalograph, peer assessment rating||Morphological features|
|Baek et al./2010||Prospective study||11 pts, SFOA (n, 20; 22.95±2.54 years||SFOA in skeletal class III||Surgical movement and postoperative orthodontic treatment||Lateral cephalographs||Morphological features|
|Wang et al./2010||Case-control retrospective||36 pts: 18 conventional jaw (23.3±4.2 years) and 18 surgery-first (22.3±3.8 years)||Patients with skeletal Class III undergoing SFOA||Conventional surgery, bimaxillary surgery||Changes of transverse dimension in both dental arches||Cephalometric measurements||Morphological features|
|Ko et al./2011||Retrospective cohort study||53 pts, Conventional jaw surgery (n, 35; 22.0±4.1 years) and SFOA (n, 18; 24.6±4.9 years)||SFOA in skeletal class III dentofacial deformities||MC approach||Dental and skeletal changes, postsurgical dental and skeletal stability, and treatment efficacy||Lateral cephalographs||Morphological features and treatment efficacy|
|Liou et al./2011||Prospective||22 adult pts||SFOA in skeletal dentofacial deformities||Postoperative changes in bone metabolism, tooth mobility||Periotest method, immunoassay||Morphological features, biomarkers|
|Ko et al./2013||Retrospective cohort study||45 pts, Conventional jaw surgery (n, 25; 25.1±6.8 years) and SFOA (n, 25; 25.4±6.4 years)||SFOA in skeletal class III dentofacial deformities||Groups based on the amount of horizontal relapse||Parameters identification related to skeletal stability after SFOA||Lateral cephalograph cephalometric measurements||Morphological features|
|Kim et al./2014||Retrospective cohort study||61 pts, Conventional jaw surgery (n, 38; 21.6±3.5 years) and SFOA (n, 23; 23.0±6.3 years)||SFOA in skeletal class III dentofacial deformities||Conventional surgery||Stability of mandibular setback surgery||Lateral cephalograph cephalometric measurements||Morphological features|
|HernándezAlfaro et al./2014||Prospective||45 pts: SFOA||SFOA in class II, III and asymmetry||Specific orthodontic and surgical protocol||VAS on patient satisfaction and orthodontists on selected treatment approach||SFOA protocol development. Adverse effects of Tx physical consequence|
|Lee et al./2014||Retrospective||40 pts (22.6±4.0 years)||SFOA in skeletal class III dentofacial deformities||Postsurgical skeletal changes||Cephalograms generated from cone-beam computed tomography||Morphological features|
|Kim et al./2014||retrospective||37 pts (23±4 years)||SFOA in skeletal class III dentofacial deformities||Postoperative stability using IVRO||Lateral cephalograph||Morphological features|
|Park et al./2014||Retrospective||60 pts: 36 conventional jaw surgery (22.4±4.4 years) and 24 SFOA (22.4±4.6 years)||SFOA class III malocclusion||Conventional surgery, bimaxillary surgery||Dental change||Lateral cephalograph||Morphological features|
|Choi et al./2015||Retrospective||n, 35 pts; 24.7 years||SFOA clockwise MMC skeletal class III deformities||Posterior pharyngeal airway change||Lateral cephalograph cephalometric measurements||Morphological features|
|Choi et al./2015||Case–control prospective||56 pts (average age, 22.4 years: conventional jaw surgery (n, 24) and SFOA (n, 32)||Surgery-first approaches for patients with skeletal class III dentofacial deformity||Conventional surgery||Reliability of a surgery-first orthognathic approach without presurgical orthodontic treatment||Dental model, Cephalometric assessment||Morphological features|
|Yu et al./2015||Retrospective cohort||50 pts (16–37 years)||Skeletal malocclusions||Report experience with the SFA for skeletal malocclusion||Morphological features|
|Park et al./2015||Case-control retrospective||40 pts: 20 conventional jaw surgery (25.25±3.77 years) and 20 SFOA (22.60±5.39 years||SFOA bimaxillary surgery||Conventional surgery, bimaxillary surgery||Postoperative stability/relapse rate||Cephalometric radiographs||Morphological features|
|Park et al./2015||Retrospective||26 pts, Conventional jaw surgery (n, 15; 25.0±3.2 years) and SFOA (n, 11; 26.2±4.4 years)||SFOA in skeletal class III dentofacial deformities||Conventional surgery||QoL||OQLQ||Oral health-related QoL|
|Rhee et al./2015||Retrospective||34 patients (23 men, 11 women; mean age, 26.2±6.6 years)||SFOA in skeletal class III dentofacial deformities||Skeletal and dental changes||Cone-beam computed tomography||Morphological features|
|Huang et al./2016||Prospective||50 pts: conventional jaw surgery (24.2±5.8 years) and SFOA (25.2±4.2 years)||SFOA class III malocclusion||Conventional surgery, bimaxillary surgery||Oral health related QoL and satisfaction between surgery-first and orthodontic-first orthognathic surgery patients||Two questionnaires: the dental impact on daily living and 14-item oral health impact profile||OHRQoL|
|Choi et al./2016||Retrospective cohort||37 pts, Conventional jaw surgery (n, 17; 20.8±0.9 years) and SFOA (n, 20; 21.1±0.7 years||SFOA in skeletal class III dentofacial deformities using IVRO||Conventional surgery using IVRO||Postoperative skeletal and dental changes||Lateral cephalograph cephalometric measurements||Morphological features|
|Wang et al./2016||Retrospective cohort||55 pts: conventional jaw surgery (n, 29; 22.2±3.8 years) and SFOA (n, 26; 21.6±3.3 years||Bilateral sagittal split ramus osteotomy for mandibular prognathism using OFA||Conventional surgery||Compare the postoperative changes of the condylar position after mandibular setback surgery||3D CT images||Morphological features|
|Akamatsu et al./2016||Retrospective cohort||38 pts (14 SFOA and 24 conventional surgery)||SFOA in skeletal class III dentofacial deformities||Conventional surgery||Postsurgical stability||Lateral cephalograph cephalometric measurements||Morphological features|
|Jeong et al./2017||Prospective||52 conventional jaw surgery (29.7 Average age) and 45 pts in SFOA (23.7 average age)||SFOA bimaxillary surgery||Conventional surgery, bimaxillary surgery||Postoperative skeletal and dental changes||Lateral cephalograph cephalometric measurements||Morphological features|
|Feu et al./2017||Prospective||16 pts, Conventional jaw surgery (n, 8; 26.8±7.1 years) and SFOA (n, 8; 22.9±5.4 years)||SFOA in skeletal class III dentofacial deformities||Conventional surgery||OQLQ and the OHIP-short version (OHIP-14)||OHIP-14||Oral health-related QoL|
|Wang et al./2017||Longitudinal prospective cohort||50 pts, Conventional jaw surgery (n, 25; 25.1±6.8 years) and SFOA (n, 25; 25.4±6.4 years)||SFOA in skeletal class III dentofacial deformities||Conventional surgery||OHRQoL||OHRQoL questionnaire||Oral health-related QoL|
|Pelo et al./2017||Retrospective cohort||30 pts (30.2±4.3 years)||SFOA in skeletal malocclusion||Conventional surgery||Level of satisfaction and QoL||OHIP, orthognathic QoL questionnaire OQLQ-22||Oral health-related QoL|
|Zingler et al./2017||Prospective cohort||9 pts ( 26.7 years)||SFOA in skeletal class III and Class II dentofacial deformities||Psychological and biological changes in SFOA||OQLQ questionnaire, sense of coherence SOC-29 and longitudinal day-to-day. crevicular fluid by bead-based multiplex assays||Oral health-related QoL biomarkers assessment|
|Hernandez-Alfaro et al./2017||Prospective||8 pts (mean age 26.3 years)||Surgery-first class III patients||Surgery-early class III patients||Complications, final outcome||Plaque index, PPD, gingival recession, bleeding on probing, and CAL. satisfaction with treatment (VAS)||Effects of Tx/Functional status/QoL|
|Jeong et al./2018||Retrospective||104 Patients (23.3 years, mean age) with SFOA, and 51 with conventional surgery (23.1 years, mean age)||SFOA in skeletal class III dentofacial deformities||Conventional surgery||long-term outcomes of vertical skeletal stability||Lateral cephalograph cephalometric measurements||Morphological features|
|Holzinger et al./2018||Prospective||16 patients aged 18–37 years (8 female, 8 male, mean age 26 years)||SFOA in skeletal malocclusion||Quantitative accuracy assessment||CT scan||Morphological features|
|Guo et al./2018||Retrospective cohort||Symmetry group (n, 17; 22.9±4.4 years) and asymmetry group (n, 12; 20.0±52.2 years)||SFOA mandibular prognathism with asymmetry||SFOA mandibular prognathism without facial asymmetry||Corrective outcomes and transverse stability||CT scan||Morphological features|
|Lian et al./2018||Retrospective||n, 37, females 24.0±4.9 years||2-step group in SFOA||3-step group in SFOA||Stability, and treatment efficiency||Lateral cephalograph cephalometric measurements||Morphological features|
|Liao et al./2018||Retrospective cohort||n, 41, 24.0±4.9 years||SFOA in Skeletal Class III facial asymmetry||Long-term outcomes of bimaxillary surgery||Photographs and study models||Morphological features|
|Brucoli et al./2018||Prospective||33 pts, Conventional jaw surgery (n, 25; 25.0±5.5 years) and SFOA (n, 8; 35.6±13.4 years)||SFOA in skeletal class III dentofacial deformities||Conventional surgery||Oral health impact profile questionnaire, TCI, RSA, Italian validation of the PIDAQ, BDIII, the RSES||Psychosocial well-being, selfe-steem, anxiety, and QoL||Oral health-related QoL|
|Liao and Lo/2018||n, 53 (n, 39 with genioplasty and n, 14 without genioplasty. Mean age, 25±6 years||Skeletal Class III patients surgery-first approach||Establish guidelines for the surgical occlusion setup of SFOA, evaluate accuracy||Study models and computer-aided surgical simulation||Guidelines, characteristics, and accuracy|
|Watanabe et al./2019||Retrospective study||5 patients (19–26 years) with facial asymmetry in hemifacial microsomia||Surgery-first approach combined with mandibular distraction||Soft tissue changes||Photographs||Morphological features|
SFOA: Surgery-first orthognathic approach, IVRO: Intraoral vertical ramus osteotomy, MMC: Maxillomandibular complex, QoL: Quality of life, OQLQ: Orthognathic quality of life questionnaire, OHIP: Oral health impact profile, SOC-29: 29-Item scale, PPD: Probing pocket depth, CT: Computed tomography, CAL: Clinical attachment level, VAS: Visual analogue scale, OHRQoL: Oral health-related quality of life, 3D: 3-Dimensional, OQLQ: Orthognathic quality of life questionnaire, VAS: Visual analog scale, TCI: Temperament and character inventory, RSA: Resilience scale for adults, PIDAQ: Psychological impact of dental aesthetics questionnaire, BDIII: Beck depression inventory second edition, RSES: Rosenberg self-esteem scale, MC: Modified-conventional, Tx: Treatment
|Study author||Reason for exclusion|
|Nagasaka et al. 2009||Case report|
|Yu et al. 2010||Case report|
|Liou et al. 2011||Technique article|
|Villegas et al. 2012||Case report|
|Kim et al. 2013||Presurgical phase duration unclear or more than 1 month before surgery|
|Joh et al. 2013||Presurgical phase duration unclear or more than 1 month before surgery|
|Park et al. 2013||Case report|
|Uribe et al. 2013||Case report|
|Teng and Liou 2014||Animal study|
|Aristizábal et al. 2015||Case report|
|Huang et al. 2015||Opinion article|
|Uribe et al. 2015||Case report|
|Pelo et al. 2016||Opinion article|
|Zhou et al. 2016||Case report|
|Zhou et al. 2016||Pre surgical phase more than 1 month before surgery|
|Gandedkar et al. 2016||Case series|
|Larson et al. 2017||Presurgical phase duration unclear or more than 1 month before surgery|
|Choi and Bradley 2017||Opinion article|
|Aristizábal et al. 2018||Case report|
Morphological features or changes in maxillofacial skeleton and occlusion.
Psychosocial well-being including quality of life outcome.
Health resource utilization.
Adverse effects of SFOA.
Framework Stage 5: collating, summarizing and reporting the results
The initial database and additional search resulted in 525 records, of which 54 potentially relevant articles were retrieved in full. 35 studies met the selection criteria following screening and were included in the scoping review with the results of the search depicted in the preferred reporting items for systematic reviews and meta-analyses flow chart [Figure 1]. The studies included in the review are shown in Table 2, and excluded studies with reasons are enumerated in Table 3. Morphological features and oral HRQoL were evaluated in the majority of studies. Morphological features or changes in maxillofacial skeleton and occlusion (n = 25, 71.42%) and psychosocial well-being including quality of life outcome (n = 8, 22.85%) were well represented with under-representation of functional status (n = 1, 2.85%), health resource utilization (n = 0), and adverse effects (n = 1, 2.85 %) [Figure 2]. No randomized control trials (RCTs) were identified with majority of the studies being retrospective in nature.
This is the first of its kind scoping review of studies that address selection of outcomes for use in SFOA clinical trials. Five outcome domains were identified, and the domains were examined for their degree of representation in the available literature. Also, to determine whether any recommendations could be made for the development of COS. Overall, the scoping review shows that SFOA evidence is in its formative stage with much emphasis placed on the assessment of morphological features and in determining the quality of life.
Clinical trials are only as credible as their outcomes. Core outcome set is an agreed, standardized group of outcomes to be reported by all the trials within the research field. COS provides a template for clinical trials such that the future clinical trials that follow the COS will have increased homogeneity, facilitate meta-analysis, reduce the risk of reporting bias, and involve a wide range of stakeholders (e.g., patients, caregivers, and health-care providers). Further, the tenets of COS state that, if no satisfactory core outcome set is found, and there is a need to develop one, then, a “scoping review” could be used as a conduit in establishing an informed base to conduct meaningful qualitative research (e.g., systematic research). Further, the scoping review assists in identifying the potential outcomes and ranks the outcomes to determine a “core” set. Although this scoping review might be unable to recommend standard COS, this scoping review has identified five outcome domains that are measured in the existing literature pertaining to SFOA. Among the 5 identified outcome domains, 2 are over-represented and 3 are under-represented [Figure 2].
Furthermore, this scoping review did not identify any RCT within the SFOA research, indicating that more pertinent research encompassing RCTs are required to arrive at formulating COS. However, the fact that many prospective studies are being carried out is itself promising in nature, and in the future, this will allow researchers and readers to make best use of the available reported trails to formulate the research question.
The shortcomings of this scoping review are predetermined outcomes and exclusion of studies having sample size <5. With outcomes being predetermined, this could have precluded from exploring other domains. Nonetheless, this is the first of its kind scoping review intended for mapping outcomes and provides plausible recommendations to develop COS for SFOA, and hence, it was essential to identify the more common outcomes and interventions. The decision to exclude case reports and studies involving less than five cases was deliberate to involve more meaningful data which could assist in identifying the more common outcome domains.
The scoping review shows that limited research has been carried out in SFOA. The outcome domains that are over-represented are morphological features or changes in maxillofacial skeleton and occlusion and psychosocial well-being including quality of life outcome. However, outcomes such as functional status, health resource utilization, and adverse effects of SOFA were under-represented. Future SFOA clinical trials should consider these aforementioned under-represented outcome domains to address the SFOA treatment modality in a comprehensive way to better understand the treatment approach and enhance the outcome consistency.
Financial support and sponsorshipNil.
Conflicts of interestThere are no conflicts of interest.
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- MATERIALS AND METHODS
- Framework Stage 1: identifying the research question
- Framework Stage 2: identifying relevant studies, and framework Stage 3: study selection
- Framework Stage 4: charting the data