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

Sponsor

Universitat Internacional de Catalunya (Other)

Overall Status

Recruiting

CT.gov ID

NCT05944419

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bone Resorption Soft Tissue Bleeding	Device: Immediate implant surgery	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized Controlled Clinical TrialRandomized Controlled Clinical Trial

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 15, 2016

Anticipated Primary Completion Date :

Sep 15, 2023

Anticipated Study Completion Date :

Sep 15, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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) [4 months]
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.
Marginal bone loss (MBL) [1 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.
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) [4 months]
the thickness of the buccal soft tissue at 3 mm and 5 mm from the gingi-val margin was measured using an endodontic file.
Soft tissue thickness (STT) [1 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.
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

Insertion torque (IT): [day 1]
the insertion torque of the implant was measured on the day of the sur-gery with the implant motor.
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): [4 months]
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.
Probing pocket depth (PPD): [1 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.
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.
Bleeding on probing (BOP): [4 months]
bleeding on probing was registered at each PPD site, whether there was bleeding or not.
Bleeding on probing (BOP): [1 year]
bleeding on probing was registered at each PPD site, whether there was bleeding or not.
Bleeding on probing (BOP): [3 year]
bleeding on probing was registered at each PPD site, whether there was bleeding or not.
Crestal width (CW) [4 months]
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.
Crestal width (CW) [1 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.
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): [4 months]
this score was measured based on the Furhauser table. Maximum: 14 points / Minimum: 0 points. Higher scores mean a better outcome.
Pink esthetic score (PES): [1 year]
this score was measured based on the Furhauser table. Maximum: 14 points / Minimum: 0 points. Higher scores mean a better outcome.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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