18
HERRERA ET AL .
The guideline text was drafted by the chairs of the WGs, in close cooperation with the methodological consultant, and was circulated among the members of each guideline group, who served as peer reviewers. The methodological quality was formally assessed by an external consultant using the AGREE framework. The study chairs approved the final guideline text prior to publication in the Journal of Clinical Periodontology .
the 2017 Medical Device Regulation (MDR, Council Regulation 2017/745) (The European Parliament and the Council of the European Union, 2017). This class of medical devices considers ‘ implantable devices and long-term (>30 days) surgically invasive devices ’ , and applies to most implants used in the orthopaedic, dental, ophthalmic and cardiovascular fields. Implantable devices are ‘ partially introduced into the human body through surgical intervention and intended to remain in place after the procedure for at least 30 days ’ (The European Commission, 2010). They can be further classified according to their expected ‘ duration ’ , either as short term (normally intended for continuous use for not more than 30 days) or long term (normally intended for continuous use for more than 30 days). In the current MDR regulation, published in 2017 (The European Parliament and the Council of the European Union, 2017) and enforced in May 2022, dental implants and dental implant abutments are considered within the category MDN 1103 (non-active dental implants and dental materials) as ‘ non-active implants and long-term surgically invasive devices ’ (The European Commission, 2017). Other non-active implants are classified in different categories as ‘ non-active cardiovascu- lar, vascular and neurovascular implants ’ (MDN 1101), ‘ non-active osteo- and orthopaedic implants ’ (MDN 1102) and ‘ non-active soft tissue and other implants ’ (MDN 1104). When developing a CPG related to dental implants (in the present case, on the management of peri-implant conditions), the CPG struc- ture could be based on similar guidelines on other ‘ long-term surgi- cally invasive devices ’ ; however, the clinical use of dental implants has a fundamental difference, since these medical devices are partially inserted in the jaws. Since the oral cavity is one of the most diverse and microbially abundant niches in the human body (Gupta et al., 2017), the intra-oral part of the implant will always be exposed to this contaminated environment. Therefore, dental implants have been specifically designed to withstand biofilm formation on the non- shedding transmucosal abutment surface', which will be covered by the appropriate prosthetic devices to serve as tooth replacements', then subject to the same measures of infection prevention control as natural teeth (OH practices). Another strategy that could have been followed in the development of this guideline was to implement a par- allel process to that undertaken for the treatment of periodontal dis- eases (Herrera et al., 2022; Sanz et al., 2020). However, the major anatomical and histological differences between periodontal and peri- implant tissues (reported in Section 1.1.2) and the histopathological dissimilarities between periodontitis and peri-implantitis lesions (Berglundh et al., 2018; Sahrmann et al., 2020; Schwarz et al., 2018) necessitated a different approach. The structure of the present guideline, therefore, must recognize the specific features of the ‘ implantable medical devices ’ and the biological distinctions between the peri-implant and periodontal diseases. Specifi- cally, interventions for the prevention and treatment of peri-implant dis- eases may be implemented prior to inserting the medical device (dental implant), at the time of placement and restoration (implant/prosthesis placement), as well as post- rehabilitation, in recognition of the high inci- dence of peri-implant diseases. Consequently, interventions were first organized according to the stage of implant therapy, applicable to:
3.7
| Implementation and dissemination plan
For this guideline, a multi-stage dissemination and implementation strategy will be established and implemented by the EFP, supported by a communication campaign. This will include: • Publication of the guideline and the underlying SRs as an Open Access special issue of the Journal of Clinical Periodontology . • Commentary, Adoption, or Adaptation (Schunemann et al., 2017) by national societies. • Generation of educational material for dental professionals and patients, and dissemination via the EFP member societies. • Dissemination via educational programmes at dental conferences. • Dissemination via the EFP through European stakeholders via National Society members of the EFP. • Long-term evaluation of the successful implementation of the guideline by a survey of EFP members.
The timeline of the guideline development process is detailed in Table7.
3.8
Validity and update process
|
The guideline is valid until 2028. However, the EFP, represented by the members of the Organizing Committee, will continuously assess current developments in the field. Where there are major changes of circumstances, for example, new relevant evidence, this will trigger an update of the guideline to potentially amend the recommendations. It is planned to update the current guideline regularly on demand and consistent with the format of a living guideline.
4 | MANAGEMENT OF PERI-IMPLANT DISEASES — PREVENTION, DIAGNOSIS AND TREATMENT SEQUENCE
4.1
| Specific approaches in the management of
peri-implant diseases
Dental implants and dental implant abutments are class IIb medical devices (The European Commission, 2010), according to the 1993 Medical Device Directive (MDD, 93/42/EEC), which are maintained in
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