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Implant Retained Rehabilitation With Surgical and Prosthetic Digital Workflow

Primary Purpose

Jaw, Edentulous, Partially

Status
Active
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Neodent GM Helix Implant
GM Customizable Healing Abutment
GM Pro PEEK Abutment
GM Exact Titanium Base
Sponsored by
Neodent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Jaw, Edentulous, Partially focused on measuring Dental Implants, Bone-Implant Interface, Mouth Rehabilitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 18 years of age or older;
  • 2 upper posterior teeth missing, with adjacent natural tooth;
  • Healed implant sites (at least 4 months post-extraction);
  • Qualify for placement of 4.0x10 mm Neodent GM Helix implants;
  • Adequate bone height to allow the 2mm subcrestal placement of a 10-mm-long implant.

Exclusion Criteria:

As exclusion criteria, solely the device contraindications according to the IFU (instructions for use) will be applied:

  • Signs of allergy or hypersensitivity to the chemical ingredients of the materials: titanium, titanium alloy (Ti6Al4V-ELI) or PEEK (Polyetheretherketone);
  • Presence of acute inflammatory or infectious processes in live tissue;
  • Unsuitable bone volume or quality;
  • Serious medical problems (e.g. bone metabolism disorders, blood clotting disorders, unsuitable healing capacity);
  • Insufficient oral hygiene;
  • Incomplete jawbone growth;
  • Patient uncooperative and not motivated;
  • Abuse of drugs or alcohol;
  • Psychosis;
  • Prolonged functional disorders which resist any treatment with medications;
  • Xerostomia;
  • Weakened immunological system;
  • Diseases which require the use of steroids;
  • Uncontrolled endocrinological diseases;
  • Pregnancy.

Sites / Locations

  • Instituto Latino Americano de Pesquisa e Ensino Odontológico (ILAPEO)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Abutment removal

Final abutment

Arm Description

At the time of surgery, customizable healing abutments will be placed on implants. These will be replaced by Pro PEEK Abutments 21 days later to placement of temporary prostheses (loading). The final abutments (Titanium Bases) and final prostheses will be inserted 2 months after loading.

The final abutments (Titanium Bases) will be placed at the time of the implant placement surgery and will stay at mouth during all period of the study. Temporary and final prosthesis will be placed on Titanium Bases.

Outcomes

Primary Outcome Measures

Amount of peri-implant bone level change
Peri-implant bone level will be measured on the periapical radiographs obtained as the distance between the coronal margin of the implant shoulder and the most coronal point of the peri-implant bone, on the mesial and distal surfaces of each implant. The horizontal measurement of the remodeling will be done, when there is no bone contact in the cervical part of the implant. This measurement will be performed from the superior site of the bone crest to the lateral edge of the implant, perpendicular to the long axis of the implant.

Secondary Outcome Measures

Implant survival
Implant survival will be defined as no loss of the implant at each follow-up.
Implant success
Evaluation of implant success will be assessed based on the criteria proposed by Buser et al.
Prosthetic survival
Prosthetic survival will be assessed as the prosthesis remaining in situ at each follow-up, irrespective of its condition.

Full Information

First Posted
August 19, 2019
Last Updated
September 9, 2022
Sponsor
Neodent
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1. Study Identification

Unique Protocol Identification Number
NCT04066309
Brief Title
Implant Retained Rehabilitation With Surgical and Prosthetic Digital Workflow
Official Title
Implant Retained Rehabilitation With Surgical and Prosthetic Digital Workflow: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 2, 2019 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Neodent

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study is to prospectively collect clinical data to confirm the safety and clinical performance of Neodent Titanium Base Abutment and Pro PEEK Abutment in daily dental practice setting, by means of a randomized clinical study of prosthetic rehabilitation using these devices. A total of 48 healed implant sites (at least 4 months post-extraction) shall be included during the sample enrollment (24 patients), which will be randomly divided into two groups, so that each patient receives one implant from each group (removal and non-removal of the abutment placed at the time of surgery). Patients will be followed for 24 months after implant loading. It is expected that there is no difference in peri-implant bone level change between the two treatment groups.
Detailed Description
The study protocol was reviewed and approved by an Ethics Committee (EC) in Brazil. Sample size was calculated based on an alpha level of 5% and beta of 20% to detect a mean intergroup difference of 0.2mm, with a standard deviation of 0.2mm, in peri-implant bone level change 24 months after implant loading. Sample size calculation showed that a sample of 17 implants is needed for each group. With rate of 2 implants per patient and a "worst-case" drop-out rate of 20%, a sample size of 24 patients resulting in an estimated number of 24 implants, in each group, is thought to be sufficient to allow statistical analysis of clinical outcome data. A total of 48 healed implant sites (at least 4 months post-extraction) shall be prospectively and consecutively selected during the sample enrollment (24 patients). Data concerning the studied variables will be collected in the following stages: Screening (First visit); TP - Implant placement; TT - Impressions for temporary prosthesis confection (2 ± 1 days prior to T0); T0 - Implant Loading (temporary prosthesis placement - 21 ± 1 days after implant placement); TF - Impressions for final prosthesis confection (10 ± 1 business days prior to T6); T2 - Final prosthesis placement (2 months ± 1 week after loading); T12 and T24 - 12 and 24 months ± 1 month, respectively, after loading. In both study groups, 4.0x10 mm Neodent GM Helix Implants will be placed 2mm subcrestally (in relation to the buccal bone plate) in the posterior region of the maxilla, under local anesthesia and with adequate bone bed preparation, as recommended by the manufacturer, using the guided surgery technique. Two implants (one of each group) will be placed in the same individual, to be restored by single prostheses. In Group 1, customizable healing abutments will be placed at the time of implant placement. Twenty-one days later, the implants will be loaded by means of placement of temporary single prostheses (early loading), fabricated with centric and eccentric occlusal contacts [1], over temporary abutments (Pro PEEK Abutment). The final prosthesis will be delivered after a 2-months period of implant loading. Thus, digital models will be obtained (intraoral scanning or conventional impression and model scanning) 10 ± 1 business days prior to T2 (TF) for the confection of the final prostheses, to be placed over Titanium Bases and Zirconia Copings, following the digital workflow. The transgingival height of the Titanium Base shall be selected by the clinician so as to leave, preferably, a distance greater than or equal to 2mm between the cementation line of the Zirconia Coping over the Titanium Base and the cementation line of the prosthesis over the Zirconia Coping due to assure better esthetics of the final prosthesis. In Group 2, the final abutment will be placed at the time of surgery and will not be replaced during the rehabilitation process. A Titanium Base and a Zirconia Coping will be placed over the implant at TP, without loading (placement of an acrylic cap, without occlusal contact, to cover the coping), planned using the initial intraoral scans. Implants will be restored following the same time interval of Group 1, with temporary prosthesis placement in 21 days after surgery, and with final prosthesis placement 2 months thereafter. The clinician shall evaluate the need to re-prepare the Zirconia Coping edge line before obtaining the digital models (intraoral scanning or conventional impression and model scanning) for prostheses confection, in order to obtain the proper distance between the previously mentioned cementation lines. In both groups, prostheses' passivity, occlusal and interproximal adjustments shall be checked, to avoid compromising the implant/prosthesis set. Standardized digital periapical radiographs and close-up view photographs will be taken in an usual daily practice frequency, as determined by the investigator to verify prostheses setting and the osseointegration process. Computed tomography Scans will be obtained, in addition to pre-surgery, at T2 for evaluation of clinical parameters and comparison with the implant position planned by guided surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Jaw, Edentulous, Partially
Keywords
Dental Implants, Bone-Implant Interface, Mouth Rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two implants (one of each group) will be placed on each subject at the same stage.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Abutment removal
Arm Type
Experimental
Arm Description
At the time of surgery, customizable healing abutments will be placed on implants. These will be replaced by Pro PEEK Abutments 21 days later to placement of temporary prostheses (loading). The final abutments (Titanium Bases) and final prostheses will be inserted 2 months after loading.
Arm Title
Final abutment
Arm Type
Experimental
Arm Description
The final abutments (Titanium Bases) will be placed at the time of the implant placement surgery and will stay at mouth during all period of the study. Temporary and final prosthesis will be placed on Titanium Bases.
Intervention Type
Device
Intervention Name(s)
Neodent GM Helix Implant
Intervention Description
4.0x10 mm Neodent GM Helix Implants will be placed 2mm subcrestally (in relation to the buccal bone plate) in the posterior region of the maxilla, under local anesthesia and with adequate bone bed preparation, as recommended by the manufacturer, using the guided surgery technique.
Intervention Type
Device
Intervention Name(s)
GM Customizable Healing Abutment
Intervention Description
Customizable healing abutments will be placed at the time of implant placement.
Intervention Type
Device
Intervention Name(s)
GM Pro PEEK Abutment
Intervention Description
Placement of temporary single prostheses (early loading), over temporary abutments.
Intervention Type
Device
Intervention Name(s)
GM Exact Titanium Base
Intervention Description
Insertion of the final abutment (Titanium Base and Zirconia Coping), following the digital workflow.
Primary Outcome Measure Information:
Title
Amount of peri-implant bone level change
Description
Peri-implant bone level will be measured on the periapical radiographs obtained as the distance between the coronal margin of the implant shoulder and the most coronal point of the peri-implant bone, on the mesial and distal surfaces of each implant. The horizontal measurement of the remodeling will be done, when there is no bone contact in the cervical part of the implant. This measurement will be performed from the superior site of the bone crest to the lateral edge of the implant, perpendicular to the long axis of the implant.
Time Frame
2, 6, 12 and 24 months after implant loading
Secondary Outcome Measure Information:
Title
Implant survival
Description
Implant survival will be defined as no loss of the implant at each follow-up.
Time Frame
2, 6, 12 and 24 months after implant loading
Title
Implant success
Description
Evaluation of implant success will be assessed based on the criteria proposed by Buser et al.
Time Frame
2, 6, 12 and 24 months after implant loading
Title
Prosthetic survival
Description
Prosthetic survival will be assessed as the prosthesis remaining in situ at each follow-up, irrespective of its condition.
Time Frame
2, 6, 12 and 24 months after implant loading
Other Pre-specified Outcome Measures:
Title
Prosthetic success
Description
Success will be defined as the prosthesis that remained unchanged and did not require any intervention, except routine occlusal adjustments, during the entire observational period.
Time Frame
2, 6, 12 and 24 months after implant loading
Title
Patient Satisfaction: OHIP-14 (Oral Health Impact Profile) questionnaire
Description
The Portuguese translation of OHIP-14 [18,19] questionnaire will be used to assess Oral Health Related Quality of Life (OHRQoL), as a measure of patient satisfaction with treatment. Scores will range from 0 (absence of negative impacts on oral health) to 28 (high frequency of negative impacts on oral health).
Time Frame
Baseline, 2, 6, 12 and 24 months after implant loading
Title
Clinician Satisfaction: VAS (Visual Analogue Scale) questionnaire
Description
The assessment will be performed by means of a questionnaire using a visual analog scale (VAS) in the form of a 10 cm horizontal line, where 0 (left end) indicates minimum satisfaction and 10 (right end) indicates maximum satisfaction. The clinician will be instructed to mark the position considered to best represent their degree of general satisfaction with patient treatment. The score will be measured in centimeters from the left end of the line to the marked point.
Time Frame
Baseline, 21 days, 2, 6, 12 and 24 months after implant loading
Title
Rate of adverse events related to the implant, prosthesis, surgery and oral health
Description
Determined by patient assessment.
Time Frame
Throughout study, up to 24 months after implant loading
Title
Keratinized Tissue Width
Description
Probes calibrated at 1, 2, 3, 5, 7, and 10 mm will be used to measure keratinized tissue width as the distance from the gingival margin to the mucogingival junction, at the mid-buccal point.
Time Frame
Baseline, 21 days, 2, 6, 12 and 24 months after implant loading

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 18 years of age or older; 2 upper posterior teeth missing, with adjacent natural tooth; Healed implant sites (at least 4 months post-extraction); Qualify for placement of 4.0x10 mm Neodent GM Helix implants; Adequate bone height to allow the 2mm subcrestal placement of a 10-mm-long implant. Exclusion Criteria: As exclusion criteria, solely the device contraindications according to the IFU (instructions for use) will be applied: Signs of allergy or hypersensitivity to the chemical ingredients of the materials: titanium, titanium alloy (Ti6Al4V-ELI) or PEEK (Polyetheretherketone); Presence of acute inflammatory or infectious processes in live tissue; Unsuitable bone volume or quality; Serious medical problems (e.g. bone metabolism disorders, blood clotting disorders, unsuitable healing capacity); Insufficient oral hygiene; Incomplete jawbone growth; Patient uncooperative and not motivated; Abuse of drugs or alcohol; Psychosis; Prolonged functional disorders which resist any treatment with medications; Xerostomia; Weakened immunological system; Diseases which require the use of steroids; Uncontrolled endocrinological diseases; Pregnancy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Larissa Trojan, PhD
Organizational Affiliation
Neodent
Official's Role
Study Chair
Facility Information:
Facility Name
Instituto Latino Americano de Pesquisa e Ensino Odontológico (ILAPEO)
City
Curitiba
State/Province
Paraná
ZIP/Postal Code
80710-150
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No

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Implant Retained Rehabilitation With Surgical and Prosthetic Digital Workflow

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