Rehabilitation of Single Aesthetic Areas Using Narrow Diameter Implants

NCT ID: NCT06528587

Last Updated: 2026-01-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 17 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2025-11-01

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.

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.

Conditions

Implant Complication

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

narrow diameter implant

Intervention Type: PROCEDURE

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

Interventions

narrow diameter implant

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

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paolo Francesco Manicone

Role: PRINCIPAL_INVESTIGATOR

Fondazione Policlinico Universitario A. Gemelli, IRCCS

Locations

Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, Roma, Italy

Countries

Italy

Other Identifiers

6683

Identifier Type: -

Identifier Source: org_study_id