The OCI development and validation process underwent three processes: the OCI detection, designing OCI, and the content validation of OCI.
The development of the OCI was based on the measurement of OC detection among orthodontists and laypeople based on the evaluation of various degrees of OC; the data was then used as a baseline to develop the OCI.
To prepare the questionnaire, photographs were obtained from patients selected from the orthodontic clinic of the Dental University Hospital at…. based on the following criteria: adult, absence of any facial asymmetry, no history of extraction, absence of any external distractor—such as eyeglasses—that may influence the evaluation, and the presence of ideal esthetic smile characteristics [26]. Two photographs were taken using a digital camera (Cannon Digital, A610, Tokyo, Japan): one extraoral photograph of a natural head position with a spontaneous smile, and one frontal intra-oral photograph with the camera placed at the OP level. The photographs obtained from the model were manipulated to create different degrees of OC using Photoshop software (Adobe Photoshop 9.0, CA, USA). For accurate manipulation, the interpupillary line in the extraoral photograph was used as a reference to digitally rotate the OP in the frontal intraoral photograph. One photograph with 0° OC was considered the original photograph. Then, through the manipulation process, the OP in the original photograph was rotated in 1° increments from 1° to 5° in a clockwise direction on the right side only. The five manipulated photographs were then flipped horizontally to create the left-sided OC (Fig. 1). For standardization purposes, the image was flipped horizontally; hence, only one side of the face would have to be manipulated to produce the desired degrees of occlusal tilt. The patient signed a consent form allowing for the use of her photographs in all desired manipulations for this study.
A sample size estimation based on a power of 0.9 at a p-value of 0.05 confirmed that the required number of participants to be enrolled was 134. Accordingly, 134 individuals participated in the study, 67 of which were orthodontists randomly selected from academic centers: …, …, and …. Each of these orthodontists had a minimum of three years of experience. The remaining 67 participants were laypeople randomly selected from among nonmedical employees at the … (Table 1). Written informed consent was obtained from all the participants enrolled in the study. The questionnaire was prepared electronically using the survey software Alchemer (Alchemer, Boulder, CO, USA) and displayed to the participants on a tablet device (Apple iPad Pro 11, Apple Inc., Cupertino, CA, USA). The questionnaire was designed to commence with items that collected participants’ demographic data, including gender and profession. These items were followed by a set of randomly arranged photographs from Fig. 1 showing different degrees of OC. To ensure that the manipulated photographs were viewed under optimal standardization conditions, the tablet device was set to a brightness of 50% and a contrast of 100%. The participants were asked to report whether they detected an OC in each photograph in less than 40 seconds. For inter and intra-examiner reliability assessments, 20 of the participants (10 orthodontists and 10 laypeople) were randomly selected to repeat the questionnaire after two weeks.
Table 1
Sample distribution of individuals recruited for OC detection.
Participants | N | Male | Female |
Orthodontists | 67 | 31 | 36 |
Laypeople | 67 | 33 | 34 |
Total | 134 | 57 | 77 |
Later, the data collected from occlusal cant detection were used as a baseline to develop an OCI. The average of the starting points, measured in degrees, of OC detection by the orthodontists and laypersons served as the boundaries or cut-off points among index grades. The index consists of four grades: grades: grade 0 refers to the absence of an OC and the OP is parallel to the true horizontal plane; grade I denotes mild OC that could not be detected by either set of evaluators (orthodontists and laypersons); grade II indicates a range of OC degrees identified only by the orthodontists; and grade III represents severe OC cases wherein the degrees of OC are detected by both the orthodontists and the laypersons. For a comprehensive description of the OC cases in the index, each grade is accompanied by the site (right or left side), with the OP tilted downward (Table 2).
Table 2
The proposed description of the OCI grades.
Grade Side | Description |
Grade 0 | | No OC is present (the OP is parallel to the true horizontal plane). |
Grade I | Right | The OP is tilted down on the right side, and the OC is NOT detected by either the orthodontists or the laypersons. |
Left | The OP is tilted down on the left side, and the OC is NOT detected by either the orthodontists or the laypersons. |
Grade II | Right | The OP is tilted down on the right side, and the OC is detected by the orthodontists only. |
Left | The OP is tilted down on the left side, and the OC is detected by the orthodontists only. |
Grade III | Right | The OP is tilted down on the right side, and the OC is detected by the orthodontists and the laypersons. |
Left | The OP is tilted down on the left side, and the OC is detected by the orthodontists and the laypersons. |
In order to validate the newly developed index, ten orthodontists from … with more than 10 years of experience were invited to participate in the validation process. Written informed consent was obtained from all evaluators enrolled in this study. The recommended range of experts for content validation studies is 5–10 [15–18]. The questionnaire was prepared electronically using the Alchemer survey software (Alchemer, Boulder, CO, USA) and displayed to the experts on a tablet device (Apple iPad Pro 11, Apple Inc.). The questionnaire commenced with the OCI table, which was presented and explained to the experts. Next, a set of the items to be assessed were presented as questions. The evaluators were then asked to rate each item based on relevance and clarity on a four-point scale (Table 3).
Table 3
Items and assessment criteria of the content validity questionnaire.
1. Diagnosis of the OC |
1a. Is the OCI relevant to the diagnosis of the OC? | 1 Not relevant | 2 Relevant but needs major revisions | 3 Relevant but needs minor revisions | 4 Very relevant |
1b. Is the OCI clear to the diagnosis of the OC? | 1 Not clear | 2 Clear but needs major revisions | 3 Clear but needs minor revisions | 4 Very Clear |
2. Side of the OC |
2a. Is the OCI relevant with respect to detecting the side of the OC? | 1 Not relevant | 2 Relevant but needs major revisions | 3 Relevant but needs minor revisions | 4 Very relevant |
2b. Is the OCI clear to detecting the side of the OC? | 1 Not clear | 2 Clear but needs major revisions | 3 Clear but needs minor revisions | 4 Very clear |
3. Cut-off points of the scoring system |
3a. Are the cut-off points of the scoring systems being relevant? | 1 Not relevant | 2 Relevant but needs major revisions | 3 Relevant but needs minor revisions | 4 Very relevant |
3b. Are the cut-off points of the scoring systems clear? | 1 Not clear | 2 Clear but needs major revisions | 3 Clear but needs minor revisions | 4 Very clear |
4. Communication |
4a. Is the OCI relevant with respect to communication among practitioners and researchers? | 1 Not relevant | 2 Relevant but needs major revisions | 3 Relevant but needs minor revisions | 4 Very relevant |
4b. Is the OCI relevant with respect to communication among practitioners and researchers? | 1 Not clear | 2 Clear but needs major revisions | 3 Clear but needs minor revisions | 4 Very clear |
5. Foundation for future modifications |
5a. Is the OCI as a foundation index relevant for any applicable future modification? | 1 Not relevant | 2 Relevant but needs major revisions | 3 Relevant but needs minor revisions | 4 Very relevant |
5b. Is the OCI as a foundation index clear for any applicable future modification? | 1 Not clear | 2 Clear but needs major revisions | 3 Clear but needs minor revisions | 4 Very clear |
Statistical Analysis:
All data were analyzed using IBM® SPSS® Statistics, Version 25 (International Business Machines Corporation; Armonk, New York, USA). Descriptive statistics were used to describe all variables.
A significant difference in OC detection between laypeople and experts was calculated (∝= 0.05) using the chi-squared test. To evaluate the inter- and intra-examiner reliability in OC detection among orthodontists and laypeople, kappa statistics were used. For the assessment of the content validity of the OCI, the content validity index (CVI) was used, including both the item-level CVI (I-CVI), which measures the proportion of experts who provided a rating of 3 or 4 to each item, and the scale-level CVI based on average (S-CVI/Ave) which reflects the average of I-CVI scores for all items on the OCI. The OCI is considered to have excellent content validity if I-CVI was equal to or more than 0.78 and S-CVI/Ave was equal to or more than 0.9; otherwise, a revision based on the experts’ opinions was deemed necessary. In addition, a modified kappa index (κ*) of inter-rater agreement is an important supplement to CVI. It was computed to provide information about the degree of agreement by eliminating any random elements.