Study Methods
Methods
Data are collected at different time points via questionnaires. Time points of data collection correspond with the appointments of the patient throughout the implant and prosthesis placement trajectory.
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In the beginning of the study dentist will follow a training on how to include patients in the study and how to fill in the questionnaires. The research team supports the dentist in the administration of the questionnaires.
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The questionnaires are administered digitally to the patient and the dentist. Patients receive the link to complete the patient-reported portion of the DENS before their appointment at the implantology practice. If they have not completed it beforehand, they will have the opportunity to do so during the appointment with the support of a practice assistant.
Burden & Risks
For the patient, the questionnaires will take less than 5 minutes to complete. The questionnaires comprise baseline characteristics, treatment aspects, and professional as well as patient perception with a maximum of 13 questions.
Patients are allowed to stop their participation at any time point. Neither the answers to the questionnaire, neither continuation of participation will influence the clinical decisions during treatment.
Implant dentists are asked to complete questionnaires after the patient appointments. The questions address various aspects of the treatment, but do not ask for extra information. The questionnaires will not influence clinical decisions during the implant placement.
Study Parameters
The following information is assessed at one or more timepoints during the treatment of implant and prosthesis placement
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The main study parameters include the patient reported outcomes at each timepoint:
- Quality of Life, functioning, aesthetics and comfort
Abd the clinical reported outcomes include:
:- Implant site, use of bone/tissue grafts, periodontal health from the implant site and neighboring teeth, occurrence and time point of complications
Other secondary parameters include:
Age, gender, oral hygiene (tooth brushing frequency, interdental cleaning, dental visits in the last year, brushing tobacco use, alcohol use and chronic medical conditions.
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Characteristics of the implant and prosthesis include: used implant and implant supported crown (single unit fixed dental prosthesis (screw- retained vs cemented)/ multiple
unit fixed dental prosthesis/ removable partial denture/ removable full denture).
Recruitment and informed consent
The patient information letter with informed consent form should be attached as a separate document.
As a first step dental implant clinics in the Netherlands and Spain are addressed to participate in this study by recruiting their patients as study participants The implant dentist will ask the patients to participate in this study. They inform the participant about the study. The study participants will receive the questionnaires via a link. This link will also include a page with a description and purpose of the study (background/aims/methods) which the participant is required to carefully read and understand. This form will provide an option to agree/disagree for participation to this study.