Rehabilitation of Single Aesthetic Areas Using Narrow Diameter Implants

NCT06528587 | Completed

• 1 other identifier: 6683
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

The scientific literature does not provide scientific evidence on how to manage patients suffering from monoedentulism with ridges having a reduced bone thickness or a reduced mesio-distal space. Narrow diameter implants could be a solution to rehabilitate patients suffering from these clinical conditions while avoiding longer, more complex and sometimes even multidisciplinary therapies. However, there is a lack of clinical studies analyzing the outcomes of rehabilitation with narrow diameter implants.

Conditions

Implant Complication

Keywords

narrow diameter implant

Outcome Measures

Primary Outcomes (1)

• peri-implant marginal bone loss in millimeters

  evaluation of the peri-implant marginal bone loss in millimeters

  12 months from implant placement

Secondary Outcomes (4)

• soft tissue evaluation in millimeters

  12 months from implant placement

• biological complication rate in percentage

  12 months from implant placement

• esthetics

  12 months from implant placement

• mechanical complication rate in percentage

  12 months from implant placement

Study Arms (1)

narrow diameter implant

Patients who have performed computer-guided implant surgery for the rehabilitation of single edentulism in the anterior region with lack of adequate bone thickness or mesio-distal space using implants with narrow diameter.

Procedure: narrow diameter implant

Interventions

narrow diameter implant PROCEDURE

Rehabilitation of single edentulism in the anterior region with narrow diameter implants and computer guided surgery.

narrow diameter implant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients aged \>18 years, in good general health, who have undergone implant rehabilitation of single edentulism in the anterior region will be selected.

You may qualify if:

• Patients who have undergone implant surgery to perform implant rehabilitation of single edentulism in the anterior region to insert a reduced diameter implant;
• ASA I and ASA II patients;
• Age \> 18yr;
• Non-smokers or smokers ≤ 5 cig/day;
• Achievement of FMPS and FMBS ≤ 15%;
• Signing of the written informed consent to participate in the study.

You may not qualify if:

• Severe general medical pathologies;
• Immunodeficiency states;
• Radiotherapy in the head and neck region;
• Uncontrolled diabetes or hypertension;
• Smokers \>5 cigs/day;
• Impossibility to carry out homogeneous and continuous follow-up;
• Documented allergy to the biomaterials used;
• Pregnancy or breastfeeding;
• Inability to provide written informed consent.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, Roma, 00168, Italy

Location

Study Officials

• Paolo Francesco Manicone

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2024
• First Posted: July 30, 2024
• Study Start: September 1, 2024
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: January 8, 2026

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)