Clinical trial NCT06528587: Rehabilitation of Single Aesthetic Areas Using Narrow Diameter Implants
Official title: Rehabilitation of Single Aesthetic Areas Using Narrow Diameter Implants With Computer Guided Implant Insertion: a Prospective Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Implant Complication
Keywords: narrow diameter implant
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2024-07-30
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: peri-implant marginal bone loss in millimeters
timeFrame: 12 months from implant placement
Secondary outcomes:
measure: soft tissue evaluation in millimeters
timeFrame: 12 months from implant placement
measure: biological complication rate in percentage
timeFrame: 12 months from implant placement
measure: esthetics
timeFrame: 12 months from implant placement
measure: mechanical complication rate in percentage
timeFrame: 12 months from implant placement
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS
state: Roma
Study officials:
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS
name: Paolo Francesco Manicone
role: PRINCIPAL_INVESTIGATOR
References: