Influence of Neck Design on Peri-implant Hard and Soft Tissues

Not Applicable

Completed

Brief Summary: The goal of this clinical trial is to test two different implant neck designs in 36 patients. The main question\[s\] it aims to answer are:

* do triangular neck designed implants placed immediately after dental extraction have the same influence on peri-implant hard and soft tissues than regular neck designed implants at one year?

* do triangular neck designed implants placed immediately after dental extraction have the same influence on peri-implant hard and soft tissues than regular neck designed implants at three years?

Participants that present an unrepairable tooth on the anterior upper maxilla will be asked to take a CBCT scan in order to verify the presence of the buccal bone. Once this is verified the patients will enter in the study and the day of the surgery they will be assigned to either control or test group.

* Control group: C1 round-neck implant

* Test groups: V3 triangular-implant neck

Researchers will compare test and control groups to see if they have the same effects on hard and soft tissues at 4 months, 1 year and 3 years.

Detailed Description: Immediate implant placement is considered to be a technique-sensitive protocol with a variety of potential risks. The interface area between the neck of the implant and the abutment is critical; it can affect the treatment outcome, particularly mar-ginal bone loss (MBL) and soft tissue behavior. Traditionally, the implant neck is circu-lar in shape; however, a new triangular neck design has recently been introduced on the market, though advanced indications of this innovative design are still lacking.

The objective of this randomized clinical trial was to compare the clinical and radiographic outcomes obtained after immediate placement of implants and temporization of two different neck geometries: a traditional round neck (RN) and an innovative neck with a triangular shape (TN).

Recruitment & Eligibility

Inclusion Criteria

healthy non-smokers or light smokers (< 10 cigarettes/day)
adults (> 18 years of age),
need for single tooth extraction of a maxillary incisor, canine or premolar
adequate oral hygiene
ability to follow instructions and attend the required appointments
presence of a length of at least 3 mm of buccal bone measuring ≥ 0.5 mm in thickness, apical to the extraction socket
stable and intact socket walls

Exclusion Criteria

patients with acute infections in the area of interest
individuals with large occlusal discrepancies and/or occlusal overload para-functions
smokers of more than 10 cigarettes/day
patients with any medical condition or medication contraindicating dental implant treatment

Arm && Interventions

Group	Intervention	Description
V3 Implant MIS Iberica	Immediate implant surgery	Implant with triangular neck macro design
C1 Implant MIS Iberica	Immediate implant surgery	Implant with circular neck macro design

Primary Outcome Measures

Name	Time	Method
Buccal bone width (BBW)	4 months	buccal bone width was measured by CBCT (iCAT®, Imaging Science International, LLC, Hatfield, PA, USA) at four points: at the implant neck, and at 1 mm, 2 mm and 3 mm above the implant neck.
Marginal bone loss (MBL)	3 years	marginal bone loss was measured on mesial and distal aspects of the implant using intraoral standardized periapical radiographs with the parallel technique. Measurements were performed using K-Pacs Work-station (Image Information Systems, Ltd.). The distance from the implant shoulder to the first bone-implant contact was measured at the mesial and distal sites.
Soft tissue thickness (STT)	3 years	the thickness of the buccal soft tissue at 3 mm and 5 mm from the gingi-val margin was measured using an endodontic file.

Secondary Outcome Measures

Name	Time	Method
Insertion torque (IT):	day 1	the insertion torque of the implant was measured on the day of the sur-gery with the implant motor.
Bleeding on probing (BOP):	3 year	bleeding on probing was registered at each PPD site, whether there was bleeding or not.
ISQ (implant stability quotient):	day 1	the ISQ was measured at implant placement using the Osstell device, which involves resonance frequency analysis (RFA) for measuring the fre-quency of vibration.
Probing pocket depth (PPD):	3 year	probing pocket depth was measured with a Marquis Color code dental probe at 6 sites covering 360ª of the tooth: three on the buccal site and three on the palatal site of each tooth.
Crestal width (CW)	3 year	at 3 mm and 5 mm from the gingival margin: a gauge compass was used to measure the whole width of the crestal volume, from palatal to ves-tibular wall.
Pink esthetic score (PES):	3 year	this score was measured based on the Furhauser table. Maximum: 14 points / Minimum: 0 points. Higher scores mean a better outcome.

Locations (1): Universitat Internacional de Catalunya
🇪🇸
Sant Cugat Del Vallès, Barcelona, Spain