Rehabilitation of Single Aesthetic Areas Using Narrow Diameter Implants (IDR)

Rehabilitation of Single Aesthetic Areas Using Narrow Diameter Implants With Computer Guided Implant Insertion: a Prospective Study

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.

Study Overview

• Status: Completed
• Conditions: Implant Complication
• Intervention / Treatment: Procedure: narrow diameter implant

Detailed Description

Dental implants are considered a predictable rehabilitation option in the event of tooth extraction or missing tooth. In some cases, the inevitable resorption of the alveolar ridge after tooth extraction can make the insertion of dental implants difficult or even impossible without the use of more advanced bone regeneration procedures. Narrow diameter implants represent an alternative treatment option in areas with limited ridge width. Narrow alveolar ridges and limited interdental or inter-implant spaces continue to pose a challenge to the clinician. In the case of a narrow ridge, two options are available: the first option is to insert a standard diameter implant following bone augmentation procedures; the second option is to use an implant with a narrow diameter. Regarding the mesio-distal gap, an adequate distance between teeth and implants is necessary to reduce subsequent bone resorption and recession of the papillae. Difficult clinical situations with limited mesio-distal space or reduced ridge width can be overcome by using narrow diameter implants. Correct three-dimensional implant positioning is the key factor to obtain, in addition to good integration, favorable prosthetic results and a good long-term aesthetic result. To optimize the insertion of the implants, reducing the intrinsic imprecision of the conventional free-hand technique, computer-guided static surgery protocols can be used to plan the angulation, position and depth of the implant with a digital software. Narrow diameter implants therefore have their own indication for the replacement of lateral incisors of the maxilla and for the incisors of the mandible.

• Study Type: Observational
• Enrollment (Actual): 17

Contacts and Locations

Study Locations

• Italy
  • Roma
    • Rome, Roma, Italy, 00168
      • Fondazione Policlinico Universitario A. Gemelli IRCCS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Rehabilitation of single edentulism in the anterior region with narrow diameter implants and computer guided surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
peri-implant marginal bone loss in millimeters	evaluation of the peri-implant marginal bone loss in millimeters	12 months from implant placement

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
soft tissue evaluation in millimeters	evaluation of marginal soft tissues levels in millimeters	12 months from implant placement
biological complication rate in percentage	evaluation of biological complications in percentage	12 months from implant placement
esthetics	evaluation of the esthetics using the PES score	12 months from implant placement
mechanical complication rate in percentage	evaluation of mechanical complications in percentage	12 months from implant placement

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Investigators: Principal Investigator: Paolo Francesco Manicone, Fondazione Policlinico Universitario A. Gemelli, IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2024
• Primary Completion (Actual): November 1, 2025
• Study Completion (Actual): November 1, 2025

Study Registration Dates

• First Submitted: July 8, 2024
• First Submitted That Met QC Criteria: July 26, 2024
• First Posted (Actual): July 30, 2024

Study Record Updates

• Last Update Posted (Actual): January 8, 2026
• Last Update Submitted That Met QC Criteria: January 7, 2026
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: narrow diameter implant
• Other Study ID Numbers: 6683

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