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Not yet recruiting NCT07332195

Implant Rehabilitations in a Hospital Setting

— Observational Patients Requiring an Implant-supported Rehabilitation Edentulous Patients Requiring an Implant-supported Rehabilitation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Patients Requiring an Implant-supported Rehabilitation, Edentulous Patients Requiring an Implant-supported Rehabilitation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Primary outcome measures

  • Peri-implant marginal bone loss [Time frame: From Implant placement to 5 year follow up.]
  • Implant survival rate [Time frame: From Implant placement to 5 year follow up.]
Secondary outcome measures (12)
  • Implant success rate [Time frame: From Implant placement to 5 year follow up.]
  • Prosthesis survival rate [Time frame: From Implant placement to 5 year follow up.]
  • Prosthesis success rate [Time frame: From Implant placement to 5 year follow up.]
  • Esthetic evaluation [Time frame: From Implant placement to 5 year follow up.]
  • Patient-Reported Outcome Measures [Time frame: From Implant placement to 5 year follow up.]
  • Volumetric analysis [Time frame: From Implant placement to 5 year follow up.]
  • Glycated hemoglobin level [Time frame: From Implant placement to 5 year follow up.]
  • Diabetes [Time frame: From Implant placement to 5 year follow up.]
  • Influence of medications relevant to bone/tissue metabolism [Time frame: From Implant placement to 5 year follow up.]
  • Osteoporosis [Time frame: From Implant placement to 5 year follow up.]
  • Cardiovascular disease [Time frame: From Implant placement to 5 year follow up.]
  • Complete Blood Count [Time frame: From Implant placement to 5 year follow up.]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • 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

Identifiers

NCT: NCT07332195 · ID 7698

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗