Implant Rehabilitations in a Hospital Setting

Официальное название

Clinical and Radiographic Analysis of Implant Rehabilitations in a Hospital Setting: a Prospective Study

Обзор

Dental implants are considered a predictable rehabilitation option for tooth extraction or missing teeth. The use of dental implants has evolved into a viable prosthetic alternative to conventional tooth-supported fixed prostheses or removable dentures, with advantages in terms of patient satisfaction and quality of life. Long-term studies have reported excellent success and survival rates for implants used in prosthetic rehabilitation. Benefits in terms of patient satisfaction and preservation of adjacent tooth structure are among the advantages of implant-supported restorations over prosthetic alternatives. However, dental implants can be subject to mechanical and biological complications. After the first year of function, marginal bone loss is minimal around most oral implants. Nevertheless, marginal bone loss or the onset of bacterial-related biological complications, such as mucositis and peri-implantitis, can occur. Despite the growing number of publications in the field of implant rehabilitation, to date only a few studies have investigated the outcomes of implant rehabilitation in a hospital setting characterized by patients with concomitant or previous systemic therapies and pathologies. The objective of this study is to evaluate the success of implant therapy, peri-implant marginal bone resorption (MBL), clinical parameters of peri-implant health, aesthetic parameters of rehabilitation, and patient-reported treatment outcomes in a sample of patients treated in a hospital setting.

Первичные конечные точки

• Peri-implant marginal bone loss [Срок оценки: From Implant placement to 5 year follow up.]
• Implant survival rate [Срок оценки: From Implant placement to 5 year follow up.]

Вторичные конечные точки (12)

• Implant success rate [Срок оценки: From Implant placement to 5 year follow up.]
• Prosthesis survival rate [Срок оценки: From Implant placement to 5 year follow up.]
• Prosthesis success rate [Срок оценки: From Implant placement to 5 year follow up.]
• Esthetic evaluation [Срок оценки: From Implant placement to 5 year follow up.]
• Patient-Reported Outcome Measures [Срок оценки: From Implant placement to 5 year follow up.]
• Volumetric analysis [Срок оценки: From Implant placement to 5 year follow up.]
• Glycated hemoglobin level [Срок оценки: From Implant placement to 5 year follow up.]
• Diabetes [Срок оценки: From Implant placement to 5 year follow up.]
• Influence of medications relevant to bone/tissue metabolism [Срок оценки: From Implant placement to 5 year follow up.]
• Osteoporosis [Срок оценки: From Implant placement to 5 year follow up.]
• Cardiovascular disease [Срок оценки: From Implant placement to 5 year follow up.]
• Complete Blood Count [Срок оценки: From Implant placement to 5 year follow up.]

Критерии участия

Критерии включения

• Patients requiring implant surgery for edentulous rehabilitation;
• Age > 18;
• Achievement of FMPS and FMBS ≤ 15%;
• Signed written informed consent to participate in the study.

Критерии исключения

• Uncontrolled diabetes or hypertension;
• Uncontrolled periodontal disease;
• Inability to perform consistent and continuous follow-up;
• Pregnancy or breastfeeding;
• Inability to provide written informed consent.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Chen ST, Buser D. Clinical and esthetic outcomes of implants placed in postextraction sites. Int J Oral Maxillofac Implants. 2009;24 Suppl:186-217. PMID 19885446
• Gelb DA. Immediate implant surgery: three-year retrospective evaluation of 50 consecutive cases. Int J Oral Maxillofac Implants. 1993;8(4):388-99. PMID 8270307
• Nir-Hadar O, Palmer M, Soskolne WA. Delayed immediate implants: alveolar bone changes during the healing period. Clin Oral Implants Res. 1998 Feb;9(1):26-33. doi: 10.1034/j.1600-0501.1998.090104.x. PMID 9590942
• Adell R, Lekholm U, Rockler B, Branemark PI. A 15-year study of osseointegrated implants in the treatment of the edentulous jaw. Int J Oral Surg. 1981 Dec;10(6):387-416. doi: 10.1016/s0300-9785(81)80077-4. PMID 6809663
• 3) Branemark PI. Introduction to osseointegration. In: BranemarkPI, Zarb GA, Albrektsson T, Rosen HM, eds. Tissue-IntegratedProstheses: Osseointegration in Clinical Dentistry. Chicago:Quintessence Publishing Company, Inc; 1985:11-76.
• den Hartog L, Slater JJ, Vissink A, Meijer HJ, Raghoebar GM. Treatment outcome of immediate, early and conventional single-tooth implants in the aesthetic zone: a systematic review to survival, bone level, soft-tissue, aesthetics and patient satisfaction. J Clin Periodontol. 2008 Dec;35(12):1073-86. doi: 10.1111/j.1600-051X.2008.01330.x. PMID 19040585
• Siadat H, Alikhasi M, Beyabanaki E. Interim Prosthesis Options for Dental Implants. J Prosthodont. 2017 Jun;26(4):331-338. doi: 10.1111/jopr.12421. Epub 2016 Jan 24. PMID 26805651

Идентификаторы

NCT: NCT07332195 · ID 7698

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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