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

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.

Study Overview

• Status: Completed
• Conditions: Bone Resorption; Soft Tissue Bleeding
• Intervention / Treatment: Device: Immediate implant surgery

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).

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Sant Cugat Del Vallès, Barcelona, Spain, 08195
      • Universitat Internacional de Catalunya

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: V3 Implant MIS Iberica; Implant with triangular neck macro design	Device: Immediate implant surgery; Placement of immediate implant and immediate provisionalization after tooth extraction
Active Comparator: C1 Implant MIS Iberica; Implant with circular neck macro design	Device: Immediate implant surgery; Placement of immediate implant and immediate provisionalization after tooth extraction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Buccal bone width (BBW)	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.	4 months
Marginal bone loss (MBL)	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.	4 months
Marginal bone loss (MBL)	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.	1 years
Marginal bone loss (MBL)	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.	3 years
Soft tissue thickness (STT)	the thickness of the buccal soft tissue at 3 mm and 5 mm from the gingi-val margin was measured using an endodontic file.	4 months
Soft tissue thickness (STT)	the thickness of the buccal soft tissue at 3 mm and 5 mm from the gingi-val margin was measured using an endodontic file.	1 years
Soft tissue thickness (STT)	the thickness of the buccal soft tissue at 3 mm and 5 mm from the gingi-val margin was measured using an endodontic file.	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insertion torque (IT):	the insertion torque of the implant was measured on the day of the sur-gery with the implant motor.	day 1
ISQ (implant stability quotient):	the ISQ was measured at implant placement using the Osstell device, which involves resonance frequency analysis (RFA) for measuring the fre-quency of vibration.	day 1
Probing pocket depth (PPD):	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.	4 months
Probing pocket depth (PPD):	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.	1 year
Probing pocket depth (PPD):	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.	3 year
Bleeding on probing (BOP):	bleeding on probing was registered at each PPD site, whether there was bleeding or not.	4 months
Bleeding on probing (BOP):	bleeding on probing was registered at each PPD site, whether there was bleeding or not.	1 year
Bleeding on probing (BOP):	bleeding on probing was registered at each PPD site, whether there was bleeding or not.	3 year
Crestal width (CW)	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.	4 months
Crestal width (CW)	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.	1 year
Crestal width (CW)	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.	3 year
Pink esthetic score (PES):	this score was measured based on the Furhauser table. Maximum: 14 points / Minimum: 0 points. Higher scores mean a better outcome.	4 months
Pink esthetic score (PES):	this score was measured based on the Furhauser table. Maximum: 14 points / Minimum: 0 points. Higher scores mean a better outcome.	1 year
Pink esthetic score (PES):	this score was measured based on the Furhauser table. Maximum: 14 points / Minimum: 0 points. Higher scores mean a better outcome.	3 year

Collaborators and Investigators

• Sponsor: Universitat Internacional de Catalunya
• Investigators: Principal Investigator: CRISTINA PORTA FERRER, Universitat Internacional de Catalunya

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2016
• Primary Completion (Actual): September 15, 2023
• Study Completion (Actual): September 15, 2023

Study Registration Dates

• First Submitted: June 7, 2023
• First Submitted That Met QC Criteria: July 5, 2023
• First Posted (Actual): July 13, 2023

Study Record Updates

• Last Update Posted (Estimated): December 14, 2023
• Last Update Submitted That Met QC Criteria: December 13, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: immediate implants; dental implants; implant neck design; immediate provisionalization; buccal bone thickness
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Bone Diseases; Bone Resorption
• Other Study ID Numbers: CIR-ECL-2016-05

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No