Implant Rehabilitations in a Hospital Setting

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Patients Requiring an Implant-supported Rehabilitation; Edentulous Patients Requiring an Implant-supported Rehabilitation

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: Carlo Lajolo, MD, DDS; Phone Number: +390630154286; Email: carlo.lajolo@unicatt.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients aged >18 years who require implant-supported rehabilitation

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Implant-supported rehabilitation; Patients aged >18 years who require implant-supported rehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peri-implant marginal bone loss	Measurements were performed in millimeters using intraoral radiographs.	From Implant placement to 5 year follow up.
Implant survival rate	Rate of dental implants remaining in situ, measured as a proportion.	From Implant placement to 5 year follow up.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implant success rate	Absence of biological and technical complications, expressed as a proportion.	From Implant placement to 5 year follow up.
Prosthesis survival rate	Rate of prostheses remaining in situ, expressed as a proportion.	From Implant placement to 5 year follow up.
Prosthesis success rate	Absence of technical complications, expressed as a proportion.	From Implant placement to 5 year follow up.
Esthetic evaluation	Assessed using the PES/WES esthetic index. Scores range from 0 to 14 for the PES and from 0 to 10 for the WES, with higher scores indicating better esthetic outcomes.	From Implant placement to 5 year follow up.
Patient-Reported Outcome Measures	Recorded using a specifically designed questionnaire and measured with a visual analogue scale (VAS) ranging from 0 to 10, with higher scores indicating better outcomes.	From Implant placement to 5 year follow up.
Volumetric analysis	Assessed by superimposing the baseline volume with the volume recorded during follow-up using intraoral scans, measured in cubic millimeters.	From Implant placement to 5 year follow up.
Glycated hemoglobin level	Analysis of glycated hemoglobin levels recorded at baseline and during follow-up.	From Implant placement to 5 year follow up.
Diabetes	Analysis of the influence of diabetes during follow-up.	From Implant placement to 5 year follow up.
Influence of medications relevant to bone/tissue metabolism	Analysis of the influence of medications relevant to bone and tissue metabolism.	From Implant placement to 5 year follow up.
Osteoporosis	Analysis of influence of osteoporosis.	From Implant placement to 5 year follow up.
Cardiovascular disease	Analysis of influence of cardiovascuar disease.	From Implant placement to 5 year follow up.
Complete Blood Count	Analysis of the influence of complete blood count parameters.	From Implant placement to 5 year follow up.

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Investigators: Principal Investigator: Carlo Lajolo, Fondazione Policlinico Universitario A. Gemelli, IRCCS

Publications and helpful links

General 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.
• 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.
• 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.
• Gelb DA. Immediate implant surgery: three-year retrospective evaluation of 50 consecutive cases. Int J Oral Maxillofac Implants. 1993;8(4):388-99.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030

Study Registration Dates

• First Submitted: November 18, 2025
• First Submitted That Met QC Criteria: January 9, 2026
• First Posted (Actual): January 12, 2026

Study Record Updates

• Last Update Posted (Actual): February 6, 2026
• Last Update Submitted That Met QC Criteria: February 5, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: ID 7698

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No