Implant Retained Rehabilitation With Surgical and Prosthetic Digital Workflow

NCT04066309 | Unknown

• 1 other identifier: CS.I.001
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Jaw, Edentulous, Partially

Keywords

Dental Implants; Bone-Implant Interface; Mouth Rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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.

  2, 6, 12 and 24 months after implant loading

Secondary Outcomes (3)

• Implant survival

  2, 6, 12 and 24 months after implant loading

• Implant success

  2, 6, 12 and 24 months after implant loading

• Prosthetic survival

  2, 6, 12 and 24 months after implant loading

Other Outcomes (5)

• Prosthetic success

  2, 6, 12 and 24 months after implant loading

• Patient Satisfaction: OHIP-14 (Oral Health Impact Profile) questionnaire

  Baseline, 2, 6, 12 and 24 months after implant loading

• Clinician Satisfaction: VAS (Visual Analogue Scale) questionnaire

  Baseline, 21 days, 2, 6, 12 and 24 months after implant loading

Study Arms (2)

Abutment removal

EXPERIMENTAL

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; Device: GM Customizable Healing Abutment; Device: GM Pro PEEK Abutment; Device: GM Exact Titanium Base

Final abutment

EXPERIMENTAL

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; Device: GM Exact Titanium Base

Interventions

Neodent GM Helix Implant DEVICE

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.

Abutment removal; Final abutment

GM Customizable Healing Abutment DEVICE

Customizable healing abutments will be placed at the time of implant placement.

Abutment removal

GM Pro PEEK Abutment DEVICE

Placement of temporary single prostheses (early loading), over temporary abutments.

Abutment removal

GM Exact Titanium Base DEVICE

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

Abutment removal; Final abutment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Neodent: lead

Study Sites (1)

Instituto Latino Americano de Pesquisa e Ensino Odontológico (ILAPEO)

Curitiba, Paraná, 80710-150, Brazil

Location

MeSH Terms

Conditions

Jaw, Edentulous, Partially

Condition Hierarchy (Ancestors)

Jaw, Edentulous; Jaw Diseases; Musculoskeletal Diseases; Stomatognathic Diseases; Mouth, Edentulous; Mouth Diseases; Tooth Diseases

Study Officials

• Larissa Trojan, PhD

  Neodent

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Two implants (one of each group) will be placed on each subject at the same stage.

Study Record Dates

• First Submitted: August 19, 2019
• First Posted: August 26, 2019
• Study Start: September 2, 2019
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: November 13, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)