Canadian Dental Patients with a Single-Unit Implant-Supported Restoration in the Aesthetic Region of the Mouth: Qualitative and Quantitative Patient-Reported Outcome Measures (PROMs)

: This article contains quantitative and qualitative patient-reported outcome measures (PROMs) collected from nine dental patients, with a single-implant in the maxillary anterior region of the mouth, recruited after obtaining consent documents. The quantitative data were obtained from participants’ demographics, frontal extraoral digital photographs, intraoral scans (IOS) of the maxillary arch, and self-administered questionnaires (where patients judged the overall, appearance, function, and comfort of their single-implant-supported crowns). Objective single-implant aesthetic index mean scores (Pink Esthetic Score/White Esthetic Score [PES/WES]) were obtained after two experienced calibrated clinicians analyzed the photographs and the three-dimensional models generated from the IOS. The self-administered questionnaires used a visual analogue scale (VAS) to obtain the patients’ subjective perceptions. The qualitative data were obtained from in-depth, semi-structured one-to-one interviews. The transcriptions from audio-recorded interview data were managed and coded, with the aid of a Computer-Assisted Qualitative Data Analysis Software (CAQDAS). These data were stored in a public repository that can be easily downloaded from a Mendeley data repository (DOI: 10.17632/sv8t6tkvjv.1).


Summary
The specific subject areas of this research fall under the umbrella of "Dentistry, Oral Surgery and Medicine" as well as "Medicine and Dentistry (General)." The parameters for data collection were adult dental patients who were at the maintenance stage after receiving an implant-supported single-crown in the upper front region of the mouth, and who lived in the province of British Columbia (Pacific Coast Region-West Coast), Canada.
Since the study aimed to provide a deeper understanding of the phenomenon (i.e., patients' experiences and perceptions with a single-tooth implant in the anterior zone), this study required a holistic assessment using an inductive qualitative method. Consequently, an adapted form of interpretative phenomenological analysis (IPA) was conducted [1][2][3]. Additionally, the researchers (K.I.A. and S.R.B.) subscribed to van Manen's recommendation for a dynamic interaction between six research steps that allowed flexibility in working intermittently or simultaneously, back and forth between steps, as a form of an "interpretative circle," depending on the evolving research needs [4,5]. The framework proposed by van Manen included the following steps: "turning to the nature of lived experience," "investigating experience as we live it," "reflecting on the essential themes that characterize the phenomenon," "describing the phenomenon in the art of writing and rewriting," "maintaining a strong and oriented relation to the phenomenon," and "balancing the research context by considering the parts and the whole" [6]. The results of this qualitative study were interpreted and presented by arranging them as themes and subthemes, relating these to the "whole", relative to understanding the phenomenon in question.
Regarding the description of the data collection, qualitative interviews, self-administered questionnaires, maxillary digital scans and the lower third of the face pictures were obtained in a university setting. The participants were encouraged to express their perspectives about a specific dental intervention, as well as to recall their satisfaction throughout the process. The participation of nine Canadian dental patients was incentivized, and all data was anonymized. The format of the table and chart data available are raw, analyzed, descriptive, and cleaned.
The data can serve for further investigation of the expectations, perceptions, and satisfaction with the treatment outcomes, of patients who had a missing tooth replaced by an implanted single crown in a university setting in Western Canada. This is the first time that qualitative data from this particular sector of the dental population have been reported.
The data can aid other investigators by comparing data from different regions of Canada or different countries, as well as data from patients treated at a university by postgraduate students and at a private practice by more experienced dental specialists. Additionally, the results may benefit from an analysis according to the available theories of patient satisfaction. Moreover, the raw data can be used for further analysis or for combining the results of the quantitative measures with new studies for meta-analytical purposes. The self-administered questionnaire can be used in other studies for its validation and for benchmarking purposes. The qualitative responses can be analyzed with qualitative software to uncover patterns and commonalities in the experiences of patients who had a single-implant crown in the upper front area of the mouth.
The data shared provide information about areas of improvement regarding the quality of care provided to patients who are missing a tooth in the most visible area of the mouth. The data may inspire other practice variation studies to understand satisfaction of partially edentulous patients. Lastly, a concise questionnaire related to PROMs of patients with a single-implant crown in the anterior zone was specially designed for this research project and is presented here in English.

Data Description
The dataset in this research article contains the data from nine (55.6% men) adult patients who had a missing tooth replaced with a single crown supported by an osseointegrated titanium implant performed by postgraduate students from the Periodontology and Prosthodontology departments at a Canadian educational institution. The number of included participants was aligned with the estimation stipulated in the study protocol [6], which was based on achieving the research data saturation of previous qualitative studies, including between six and twelve individual interviews [1,[7][8][9][10].
After informed consent was obtained from all subjects involved in the study, their records were verified for the presence of a tooth removal information and a consent form (Figure 1  The self-administered questionnaire used a visual analogue scale (VAS) to assess patients' satisfaction quantitatively after having their single dental implant in the front of the fully functional mouth, as previously proposed by Afrashtehfar et al., 2021 [11]. The raw data of the questionnaire contain patients' responses ( Table 1) to each of the six items of the self-administered questionnaire. Mean values and standard deviations were calculated to obtain the overall scores from each participant and each question. The questionnaire included 6 items about the participants' perceptions of the single-tooth implant regarding: overall satisfaction, comfort, tooth appearance, gum appearance, function, and cleaning complexity [11]. The self-administered questionnaire used a visual analogue scale (VAS) to assess patients' satisfaction quantitatively after having their single dental implant in the front of the fully functional mouth, as previously proposed by Afrashtehfar et al., 2021 [11]. The raw data of the questionnaire contain patients' responses ( Table 1) to each of the six items of the self-administered questionnaire. Mean values and standard deviations were calculated to obtain the overall scores from each participant and each question. The questionnaire included 6 items about the participants' perceptions of the single-tooth implant regarding: overall satisfaction, comfort, tooth appearance, gum appearance, function, and cleaning complexity [11]. The scores from the two calibrated clinical examiners (K.I.A. and K.I.) were averaged to obtain the objective assessment scores of each item evaluated (Table 2) according to the literature [11][12][13]. Five items for the tooth (WES) and gum (PES) portions of the implant tooth were evaluated, in a comparison of similarities with the contralateral natural tooth. The highest score (similar aesthetic outcome) received in each item was 2, whereas the lowest score (dissimilar aesthetic outcome) received was 0. Anything in the middle received a score of 1. Therefore, the maximum score that each evaluated portion could add up to was 10, and the maximum combined score was 20. Each portion that received a score of less than 6 and a combined score of less than 12 was considered an unacceptable aesthetic outcome [11,12]. In this group of participants, most (5/9) had an overall unacceptable aesthetic outcome ( Table 2).
The primary data collected for this research project were qualitative participant perceptions gathered through semi-structured, one-to-one, in-depth interviews with each participant, using an interview guide based on open-ended questions [6], guided by the literature [14][15][16][17][18] on the subject and the research question. The interview guide consisted of six sections: introductory background questions (icebreakers); patients' overall satisfaction with their implant tooth, the appearance of their implant tooth, the function and social experiences relating to their implant-tooth; as well as any other important experiences which affected their satisfaction with their implant tooth, such as complications, maintenance, financial aspects, and surgical aspects of the implant tooth treatment. One author (K.I.A.) conducted all the interviews and discussed the obtained data with another author (S.R.B). Thus, several questions were added to the original version of the guide as the interviews of the first participants evolved, creating an opportunity to extract more information about issues surrounding the research question [14] (Table 3).  Table 3. Questions added to the interview guide during the data collection phase.

Part 1: Introductory Background Questions (Icebreaker)
How long ago did you come to lose your tooth? How did you get interested/motivated in dental implants? How did you come to make the decision? Were you provided enough information at school (dental specialty students) for deciding to have an implant? What was the most attractive idea about having an implant? How long did it take you to make the decision to have an implant? What information would you wish you had at the beginning to be better prepared before going for the implant? Did you investigate the risks of something going wrong? How comfortable would you be now if you needed a new implant in another place?

Part 2: Is about Your Overall Satisfaction with the Implant Tooth
So, would you say the overall results were better or worse than expected? Why?

Part 3: Is about Your Satisfaction with the Appearance (or Look) of Your Implant Tooth
Do you feel you received enough information about what to expect? What would you liked to have been explained better? Was the result better or worse than expected?

Part 4: Is about Satisfaction with Your Functioning and Social Experiences Relating to Your Implant Tooth
Is there anything you expected to be able to do with your dental implant that you cannot? What? Why? After having the dental implant, has there been any kind of improvement in (1) confidence, (2) self-image/self-esteem, (3) social life? How? Could you give an example?

Part 5: Any other Important Experiences that Affect Satisfaction with Your Implant Tooth, such as Complications, Maintenance or Financial Aspects
Was there any lip biting or discomfort immediately after the crown was implanted?

Part 6: Surgical Aspects of the Implant Tooth Treatment
What were your feelings immediately after the surgery procedure? What can be improved for the future? (e.g., if you or your friend/relative had the procedure) Please describe your recovery from the implant surgery. Do you feel you received enough information about the recovery process? Was the recovery process better or worse than expected? What was the worst part of your implant experience? Did you have any complications during the surgery or healing period? Did you have other issues such as pain or distress during the healing period? How long did the implant take? How long do you expect your implant to last? Do teeth or implants last longer? What is peri-implantitis? Can implants get infected? Are teeth or implants more resistant to infections around the bone and gums?
Repository qualitative answers to the interview are available at: http://dx.doi.org/10 .17632/sv8t6tkvjv.1#file-ab78ccec-788c-4913-8daa-3334b8dfcc4d (Accessed date: 19 June 2021). This repository [19] contained several coded sections displayed as tables according to the chronological events during the treatment and the meanings conveyed by the prevalence of the identified expressions of the participants.

Experimental Design, Materials and Methods
The designed questionnaires were used to explore patients' perceptions and satisfaction with their implant treatment experience and the treatment outcome. The patients who volunteered to participate, read and signed an informed consent form ( Table 4) which stated that they could withdraw from the study at any given moment without consequences and ensure their anonymity. The data collection has been conducted in one university dental clinic in the Pacific region of Canada. This study is part of the research project at the Faculty of Dentistry. Results of the study will be written up for publication in a scholarly journal.
Purpose of our study: You have been invited to participate in this study at the Faculty of Dentistry to explore your perceptions and experiences with a single dental implant in the front of the mouth. What will happen? We will take a dental impression of your upper teeth in addition to two clinical pictures of your teeth. We will also ask you questions about comfort and satisfaction with your implant tooth. If you agree, we will use audio recorders to help us document your opinions, and we will give you an opportunity to read and modify the word transcript of the interview. The visit to the clinic and interview will require up to two hours of your time. Risks and benefits to you: The interview will ask you to think about the comfort and satisfaction of your mouth and implant tooth during usual daily activities. By participating, you will have an opportunity to express your thoughts and feelings. However, we are not able to take a treatment role in this study, so if you need to, we would recommend that you return to your existing dentist for any follow-up. Confidentiality: Your participation and all information that you give us will be confidentially stored on two password-protected and encrypted laptop computers. These will be available only to the investigators. You will not be identified personally in any of the reports of the study and the statements will only be identified by a pseudonym (not your real name). All of the recordings and study data will be deleted ten years after publication of the project. Compensation: As an honorarium for your participation, we will pay you CAD xx.00 at the end of the interview. Contact information: If you have any concerns or complaints about your rights as a research participant and/or your experiences while participating in this study, contact the Research Participant Complaint Line in the Office of Research Ethics: e-mail xxxx@xxx.ubc.ca or call toll free x-xxx-xxx-xxxx. Consent: Your participation in this study is entirely voluntary. You can choose not to answer any question and to withdraw from the study at any time without consequences to your dental care at UBC or elsewhere. You have received all the information you requested about the study and you know who you can contact if you have questions.
I acknowledge my receipt of a copy of this consent form, and I consent to participate in this study. _________________________ _______________________ ________________ Print Participant's Name Participant's Signature Date _________________________ _______________________ ________________ Investigator's Name Investigator's Signature Date All the items were coded and scored; however, the interpretation is not available at this data set. NVivo version 12 qualitative software (QSR International Pty Ltd.; Melbourne, Australia) was the computer-assisted qualitative data analysis software (CAQDAS) (NVivo version 12 qualitative software [QSR International Pty Ltd.; Melbourne, Australia]) utilized to analyze the qualitative data, whereas MS Excel (Microsoft Corporation, Redmond, Washington) was used to record the quantitative data.