Rehabilitation of Single Aesthetic Areas Using Narrow Diameter Implants

Not yet recruiting

• Conditions: Implant Complication
• Interventions: Procedure: narrow diameter implant

• Registration Number: NCT06528587
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-08
• Study First Submitted QC: 2024-07-26
• Last Update Submitted: 2024-07-26
• Study First Posted: 2024-07-30
• Last Update Posted: 2024-07-30
• Study Start: 2024-09-01
• Primary Completion: 2025-11-01
• Study Completion: 2025-11-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 16

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
narrow diameter implant	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.

Primary Outcome Measures

Name	Time	Method
peri-implant marginal bone loss in millimeters	12 months from implant placement	evaluation of the peri-implant marginal bone loss in millimeters

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS; 🇮🇹 Rome, Roma, Italy