Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Implant Retained Rehabilitation With Surgical and Prosthetic Digital Workflow

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04066309
Recruitment Status : Recruiting
First Posted : August 26, 2019
Last Update Posted : March 30, 2020
Sponsor:
Information provided by (Responsible Party):
Neodent

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.


Condition or disease Intervention/treatment Phase
Jaw, Edentulous, Partially Device: Neodent GM Helix Implant Device: GM Customizable Healing Abutment Device: GM Pro PEEK Abutment Device: GM Exact Titanium Base Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two implants (one of each group) will be placed on each subject at the same stage.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Implant Retained Rehabilitation With Surgical and Prosthetic Digital Workflow: A Randomized Clinical Trial
Actual Study Start Date : September 2, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: Abutment removal
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.
Device: Neodent GM Helix Implant
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.

Device: GM Customizable Healing Abutment
Customizable healing abutments will be placed at the time of implant placement.

Device: GM Pro PEEK Abutment
Placement of temporary single prostheses (early loading), over temporary abutments.

Device: GM Exact Titanium Base
Insertion of the final abutment (Titanium Base and Zirconia Coping), following the digital workflow.

Experimental: Final abutment
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.
Device: Neodent GM Helix Implant
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.

Device: GM Exact Titanium Base
Insertion of the final abutment (Titanium Base and Zirconia Coping), following the digital workflow.




Primary Outcome Measures :
  1. Amount of peri-implant bone level change [ Time Frame: 2, 6, 12 and 24 months after implant loading ]
    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 :
  1. Implant survival [ Time Frame: 2, 6, 12 and 24 months after implant loading ]
    Implant survival will be defined as no loss of the implant at each follow-up.

  2. Implant success [ Time Frame: 2, 6, 12 and 24 months after implant loading ]
    Evaluation of implant success will be assessed based on the criteria proposed by Buser et al.

  3. Prosthetic survival [ Time Frame: 2, 6, 12 and 24 months after implant loading ]
    Prosthetic survival will be assessed as the prosthesis remaining in situ at each follow-up, irrespective of its condition.


Other Outcome Measures:
  1. Prosthetic success [ Time Frame: 2, 6, 12 and 24 months after implant loading ]
    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.

  2. Patient Satisfaction: OHIP-14 (Oral Health Impact Profile) questionnaire [ Time Frame: Baseline, 2, 6, 12 and 24 months after implant loading ]
    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).

  3. Clinician Satisfaction: VAS (Visual Analogue Scale) questionnaire [ Time Frame: Baseline, 21 days, 2, 6, 12 and 24 months after implant loading ]
    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.

  4. Rate of adverse events related to the implant, prosthesis, surgery and oral health [ Time Frame: Throughout study, up to 24 months after implant loading ]
    Determined by patient assessment.

  5. Keratinized Tissue Width [ Time Frame: Baseline, 21 days, 2, 6, 12 and 24 months after implant loading ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04066309


Contacts
Layout table for location contacts
Contact: Waleska Furquim, PhD 55 41 21694000 ext 4159 waleska.furquim@neodent.com
Contact: Gabriela Favre 55 41 21694000 ext 4179 gabriela.favre@neodent.com

Locations
Layout table for location information
Brazil
Instituto Latino Americano de Pesquisa e Ensino Odontológico (ILAPEO) Recruiting
Curitiba, Paraná, Brazil, 80710-150
Contact: Dr. Ana Toyofuku, PhD         
Principal Investigator: Leandro E. Klüppel, PhD         
Sponsors and Collaborators
Neodent
Investigators
Layout table for investigator information
Study Chair: Larissa Trojan, PhD Neodent
Layout table for additonal information
Responsible Party: Neodent
ClinicalTrials.gov Identifier: NCT04066309    
Other Study ID Numbers: CS.I.001
First Posted: August 26, 2019    Key Record Dates
Last Update Posted: March 30, 2020
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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
Keywords provided by Neodent:
Dental Implants
Bone-Implant Interface
Mouth Rehabilitation
Additional relevant MeSH terms:
Layout table for MeSH terms
Jaw, Edentulous
Jaw, Edentulous, Partially
Mouth, Edentulous
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases
Jaw Diseases
Musculoskeletal Diseases