Original Title: Prise en charge implanto-prothétique de l'édentement : édentement complet par prothèse amovible complète implanto retenue et édentement unitaire par prothèse fixée unitaire supra implantaire :

Authors' objectives: Following a request from the French National Health Insurance, the main objective of the evaluation was to give an opinion to the applicant with a view to obtain potential reimbursement for oral implantology procedures in two indications : - Complete edentulism with an implant-retained overdenture ; - One missing tooth replacement with single implant-supported crown. In order to promote good practice, the evaluation was divided into three parts corresponding to the therapeutics sequences in implantology : a first report about the pre-therapeutic assessment phase, a second concerning therapeutic implantology procedures including the analysis of efficacy and safety, and the third dealing with the post-therapeutic phase of monitoring and maintenance phase, which also includes a section on the general principles of management of peri-implant diseases, mucositis and peri-implantitis.

Authors' results and conclusions: For each report, the main findings and conclusions were as follows : - 1/ The pre-therapeutic assessment phase in implantology the process of assessing the possibility of treating an edentulous tooth with an implant supported prosthesis, as well as all planning aspects and the practitioner’s obligations in terms of informed patient consent, the constitution of a medical record and all aspects of medical device traceability. The essential points are that there are no contraindications to implantology, however these procedures must be carried out under the right conditions (e.g. in a clean mouth with good oral hygiene and in absence of active pathologies), and that the choice of treatment must always be made in consultation with the patient. In the case of multidisciplinary management, the treatment plan must be discussed in advance, a medical record must be drawn up to ensure continuity of care and optimal follow-up, including traceability data. - 2/ The key points of the second report on therapeutic implantology procedures include : o Analysis of data on implant-supported prostheses show that they perform well in terms of efficacy and safety and that they can provide benefits, particularly in terms of patient-reported outcomes measures (PROMS) such as improved quality of oral life, thanks to better retention of removable dentures compared with conventional mucosa-supported removable dentures thus improving nutrition ; o With regard to the implant retained single crown, clinical performance (survival rates, mechanical and biological complications) are similar to those of the dental supported alternatives (fixed dental prostheses, resin bonded bridges....) and data therefore support its use for replacement of a single missing tooth ; the preservation of the tooth should ideally be preferred before considering its avulsion, and there are many factors that guide the decision and criteria for choosing between tooth supported prostheses and implant retained single crowns ; o With regards to safety aspects, the main potential peri-operative complications of implant surgery are sensitivity disorders of traumatic origin (mainly inferior alveolar nerve lesions), trauma to adjacent teeth and damage to the maxillary sinus (infection, projection of the implant into the sinus). Their risk of occurrence can be reduced by a systematic approach before, during and after the operation ; o The use of pre-operative antibiotic prophylaxis to reduce the risk of implant failure and/or infections is not justified in the case of a simple surgery in the general population. However, there are indications for antibiotic prophylaxis in more complex implant surgeries, depending on the patient’s medical risk factors. Patients at high risk of infective endocarditis should also receive antibiotic prophylaxis prior to any invasive procedure, particular implant surgery. - 3/ On the third and final report on the post-treatment and maintenance phase, the key points are that after implant therapy, regular sessions of professional maintenance sessions are required, corresponding to a clinical and radiological follow-up and the carrying out prophylactic procedures (dental scaling, denture cleaning...) with the aim of preventing biological and mechanical complications, intercepting them early and ultimately avoiding implant loss. The patient plays an active role in the therapy and is responsible for his or her own personal care, including all the techniques and methods required for optimal oral hygiene (regular brushing, use of inter-dental brushes). Any mucositis detected (peri implant gingival inflammation) must be treated promptly to avoid the transition to peri-implantitis, which is inflammation and bone loss around the implant that may develop rapidly. Management may be non-surgical (mechanical debridement) and/or surgical (flap surgery, regenerative or resective therapy). Results are not always predictable and there are criteria for deciding whether to keep the implant or remove it, such as mobility, the patient’s medical risk factors (notably infective endocarditis), the presence of pain, the level of bone loss and its rate of progression (...).

Authors' recommendations: Overall, HAS is in favour of including in the CCAM the implantology procedures defined in the application to the French National Health Insurance and all the stages in the care pathways, i.e., the pre-therapeutic phase, surgical placement of implants, placement of an implant retained single crowns or a implant-supported complete overdenture, supportive therapy (maintenance), management of mucositis and peri implantites and temporary prostheses.

Authors' methods: The methods used to conduct this evaluation included a critical analysis of synthetic literature (in particular systematic reviews with or without meta-analysis, and best practice guidelines), consultation via a working group of oro-facial practitioners (dentists, maxillofacial surgeons, and oral surgeons) as well as patients as individual experts. All these elements were compiled into three reports (one per phase, as mentioned above) and sent to stakeholders (patient organizations and professional/academic bodies) involved in the appointment of experts, to obtain their general comments on the reports and conclusions. Institutions were also invited to provide information on specific aspects of the assessment (mainly regulatory aspects). The conclusions have been reviewed by the Health Care Management Committee (CRPPI), one of HAS’ specialized appraisal committee which examines recommendations, relevant care, care pathways and indicators. The HAS Board has validated these conclusions.

Authors' identified further research: Once this assessment has been finalized, the HAS plans to produce the aid of the Public Involvement Department, patient information sheets to support patients and users. These sheets will focus on three areas: firstly, explanations of various therapies used in tooth loss, (including those involving implants); secondly, a reminder of practitioners' duties in terms of information, informed consent, medical record keeping and traceability; and thirdly, a description of oral hygiene techniques. It is also planned to produce summary sheets for oro-facial practitioners, general practitioners and geriatricians, to inform them about possible therapies for tooth loss.

Project Status: Completed

URL for project: https://www.has-sante.fr/jcms/p_3356489/fr/prise-en-charge-implanto-prothetique

URL for protocol: https://www.has-sante.fr/upload/docs/application/pdf/2022-07/cadrage_implantologie.pdf

Year Published: 2024

URL for published report: https://www.has-sante.fr/jcms/p_3356489/fr/prise-en-charge-implanto-prothetique

Requestor: French National Health Insurance ; Ministry of health ; Regional heath agencies

English language abstract: There is no English language summary available

Publication Type: Full HTA

Country: France

Organisation Name: Haute Autorité de Santé

Contact Address: 2 avenue du Stade de France, 93218 Saint-Denis La Plaine Cedex, France. Tel: +33 01 55 93 71 88; Fax: +33 01 55 93 74 35;

Contact Name: has.seap.secretariat@has-sante.fr

Contact Email: has.seap.secretariat@has-sante.fr

Copyright: <p>Haute Autorite de Sante/French National Authority for Health (HAS)</p>