Clinical trial NCT05944419: Influence of Neck Design on Peri-implant Hard and Soft Tissues
Official title: Influence of Neck Design on Peri-implant Hard and Soft Tissues
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bone Resorption
Soft Tissue Bleeding
Keywords: dental implants
implant neck design
immediate implants
immediate provisionalization
buccal bone thickness
Lead sponsor: Universitat Internacional de Catalunya
Sponsor class: OTHER
First posted: 2023-07-13
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Clinical Trial
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Buccal bone width (BBW)
timeFrame: 4 months
measure: Marginal bone loss (MBL)
timeFrame: 4 months
measure: Marginal bone loss (MBL)
timeFrame: 1 years
measure: Marginal bone loss (MBL)
timeFrame: 3 years
measure: Soft tissue thickness (STT)
timeFrame: 4 months
measure: Soft tissue thickness (STT)
timeFrame: 1 years
measure: Soft tissue thickness (STT)
timeFrame: 3 years
Secondary outcomes:
measure: Insertion torque (IT):
timeFrame: day 1
measure: ISQ (implant stability quotient):
timeFrame: day 1
measure: Probing pocket depth (PPD):
timeFrame: 4 months
measure: Probing pocket depth (PPD):
timeFrame: 1 year
measure: Probing pocket depth (PPD):
timeFrame: 3 year
measure: Bleeding on probing (BOP):
timeFrame: 4 months
measure: Bleeding on probing (BOP):
timeFrame: 1 year
measure: Bleeding on probing (BOP):
timeFrame: 3 year
measure: Crestal width (CW)
timeFrame: 4 months
measure: Crestal width (CW)
timeFrame: 1 year
measure: Crestal width (CW)
timeFrame: 3 year
measure: Pink esthetic score (PES):
timeFrame: 4 months
measure: Pink esthetic score (PES):
timeFrame: 1 year
measure: Pink esthetic score (PES):
timeFrame: 3 year
Other outcomes:
Locations:
city: Sant Cugat Del Vallès
country: Spain
facility: Universitat Internacional de Catalunya
state: Barcelona
Study officials:
affiliation: Universitat Internacional de Catalunya
name: CRISTINA PORTA FERRER
role: PRINCIPAL_INVESTIGATOR
References: