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NCT Number: NCT07332195

Implant Rehabilitations in a Hospital Setting

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Peri-implant marginal bone loss

    Time frame: From Implant placement to 5 year follow up.

    Measurements were performed in millimeters using intraoral radiographs.

  2. Implant survival rate

    Time frame: From Implant placement to 5 year follow up.

    Rate of dental implants remaining in situ, measured as a proportion.

Secondary outcomes

  1. Implant success rate

    Time frame: From Implant placement to 5 year follow up.

    Absence of biological and technical complications, expressed as a proportion.

  2. Prosthesis survival rate

    Time frame: From Implant placement to 5 year follow up.

    Rate of prostheses remaining in situ, expressed as a proportion.

  3. Prosthesis success rate

    Time frame: From Implant placement to 5 year follow up.

    Absence of technical complications, expressed as a proportion.

  4. Esthetic evaluation

    Time frame: From Implant placement to 5 year follow up.

    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.

  5. Patient-Reported Outcome Measures

    Time frame: From Implant placement to 5 year follow up.

    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.

  6. Volumetric analysis

    Time frame: From Implant placement to 5 year follow up.

    Assessed by superimposing the baseline volume with the volume recorded during follow-up using intraoral scans, measured in cubic millimeters.

  7. Glycated hemoglobin level

    Time frame: From Implant placement to 5 year follow up.

    Analysis of glycated hemoglobin levels recorded at baseline and during follow-up.

  8. Diabetes

    Time frame: From Implant placement to 5 year follow up.

    Analysis of the influence of diabetes during follow-up.

  9. Influence of medications relevant to bone/tissue metabolism

    Time frame: From Implant placement to 5 year follow up.

    Analysis of the influence of medications relevant to bone and tissue metabolism.

  10. Osteoporosis

    Time frame: From Implant placement to 5 year follow up.

    Analysis of influence of osteoporosis.

  11. Cardiovascular disease

    Time frame: From Implant placement to 5 year follow up.

    Analysis of influence of cardiovascuar disease.

  12. Complete Blood Count

    Time frame: From Implant placement to 5 year follow up.

    Analysis of the influence of complete blood count parameters.

Study contacts

Contact information is provided by the study sponsor or research team.

Carlo Lajolo, MD, DDS

CONTACT

[email protected]

+390630154286

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Jan 12, 2026
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.