How three prosthetic methods affect bone levels around dental implants

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.