How three prosthetic methods affect bone levels around dental implants
The Effect of Prosthetic Modality on Bone Level Changes During One-Year Follow-Up
This trial will test whether three different prosthetic approaches for posterior dental implants change marginal bone levels around the implant over one year in adults eligible for Lance implants.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Studio Odontoiatrico Associato Dr. P. Cicchese e L. Canullo Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Roma, RM) |
| Trial ID | NCT07156110 on ClinicalTrials.gov |
What this trial studies
This is a randomized interventional study enrolling 60 consecutive adult patients who need one or more adjacent posterior implants (positions 4–7). Participants are assigned to one of three 20-patient groups comparing (1) Lance Conical implant with delayed screw-retained restoration on a Ti‑Base after healing, (2) Lance+ (internal hex) implant with the same delayed Ti‑Base restoration, and (3) Lance Conical with a connect abutment placed at implant insertion using a one-abutment–one-time protocol, followed by a screw-retained restoration at three months. The primary outcome is radiographic marginal bone level (MBL) change measured over one year, with standardized radiographs at baseline and follow-up visits. Eligible patients must have adequate bone quality and be willing to attend planned follow-ups at the Rome study site.
Who should consider this trial
Good fit: Adults (≥18 years) with one or more adjacent missing posterior teeth who have adequate bone quality for Lance implants and can attend follow-up visits are ideal candidates.
Not a fit: Patients with systemic conditions affecting bone healing (for example uncontrolled endocrine disorders, recent chemotherapy/radiation, renal failure, osteoporosis), poor ability to maintain oral hygiene, or those who do not meet implant size/position requirements are unlikely to benefit.
Why it matters
Potential benefit: If successful, the results could help clinicians choose prosthetic methods that better preserve marginal bone around implants and improve long-term implant stability.
How similar studies have performed: Animal and some clinical data have described soft-tissue adaptation and suggested benefits of one-abutment–one-time approaches for preserving tissue architecture, but direct clinical comparisons of these exact prosthetic modalities remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: 1. Male or female ≥18 years old. 2. One or more adjacent missing teeth in the posterior maxilla or mandible (positions 4-7). A natural tooth had to be present at the mesial end; however, free-end situations were allowed. 3. Adequate bone quality )D1-3) and availability for Lance Conical implant (MIS Implants, Israel) placement of diameters 3.75 mm or 4.2 mm, length 10-13 mm, 4. Patients are willing to participate and attend the planned follow-up visits. Systemic exclusion criteria: 1. Medical conditions requiring prolonged use of steroids and/or medications that can interfere with bone metabolism. 2. History of leukocyte dysfunction and deficiencies. 3. History of neoplastic disease requiring the use of radiation or chemotherapy. 4. History of renal failure. 5. Metabolic disorders such as osteoporosis. 6. History of uncontrolled endocrine disorders. 7. Physical handicaps that would interfere with the ability to perform adequate oral hygiene. 8. Use any investigational drug or device within 30 days immediately before implant surgery. 9. Alcoholism or any drug abuse. 10. History of immunodeficiency syndromes. 11. Smokers of 10 cigarettes per day, cigar equivalents, or tobacco chewers. 12. In the investigator's opinion, conditions or circumstances would prevent completion of study participation or interfere with the analysis of the study results, such as history of non-compliance or unreliability. Local exclusion criteria 1. Any bone augmentation performed on the implant site with a healing period of less than 3 months. 2. Local inflammation (including untreated periodontitis). 3. Mucosa disease such as erosive lichen planus 4. History of local irradiation therapy. 5. Presence of osseous lesions 6. History of implant failure 7. Postextraction sites with less than 6 weeks of healing 8. Sever bruxism or cjenching habits 9. Persistent intraoral infection. 10. Bone type 4. Exclusion criteria at surgery 1. Lack of primary stability less than 35 Ncm. 2. Need for augmentation procedures during implant surgery. 3. Inability to place the implant according to the prosthetic requirements.
Where this trial is running
Roma, RM
- Studi Odontoiatrici Luigi Canullo — Roma, Rm, Italy (Recruiting)
Study contacts
- Principal investigator: luigi Canullo, prof — Studi Odontoiatrici Canullo
- Study coordinator: Luigi Canullo, prof
- Email: luigi.canullo@gmail.com
- Phone: 3476201976
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.