Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04328116
Other study ID # CS.O.008
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date July 15, 2020
Est. completion date March 2024

Study information

Verified date November 2023
Source Neodent
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

GM Zygomatic implant is intended to be surgically placed in the posterior region of the maxilla and zygoma. It is indicated for multiple prostheses in case of severe resorption in the maxilla and total edentulism (situations in which the installation of convectional implants is contraindicated). The objective of the study is to confirm the long-term safety and clinical performance of GM Zygomatic implants and GM Zygomatic abutments in daily dental practice setting, by means of a prospective collection of clinical data concerning the success and survival rates of these devices. Devices will be used according to standard routine in daily practice, according to all indications as specified by the manufacturer in the instructions for use (IFU). Ten patients will be followed for 36 months and monitored for Adverse Events by the Investigators until the last protocol-related procedure of a patient is completed.


Description:

The study protocol was reviewed and approved by an Ethics Committee (CE) in Brazil. GM Zygomatic implants present an optimized design with adapted treatment protocol, allowing for treatment of patients with severely resorbed maxilla and complete edentulism in which conventional implants placement is contraindicated. The objective of the study is to confirm the long-term safety and clinical performance of implants and abutments of GM Zygomatic System in a daily dental practice setting, by means of a prospective collection of clinical data in a study using these devices. Additionally, from the collected data, the study aims to identify previously unknown side-effects and monitor the known side-effects and contraindications stated on the Instructions for Use with the intent to verify that the intended purpose is adequate for all Neodent products involved in the procedure that come into contact with the patient. The sample will be prospectively selected and will consist of 10 patients with atrophic edentulous maxillae, for whom the responsible surgeon elects the rehabilitation by means of placement of zygomatic implants as having the best risk-benefit ratio for the patient (e.g., shorter treatment time and lower biological cost than the associated with reconstructive surgeries for the insertion of conventional implants). Informed consent in writing will be obtained from each patient participating in the study prior to any study-related procedure. Neodent GM Zygomatic implants will preferably be placed under local anesthesia and sedation (according to the surgeon's assessment of the patient's general health), with adequate bone bed preparation, as recommended by the manufacturer. Size, position, and quantity of implants (2 to 4) will be select considering the anatomy, region of rehabilitation, bone quality and quantity and available space. Together with the Zygomatic Implants, 2 to 4 conventional implants of Neodent GM line shall be inserted in the anterior region, if enough bone is available. Data concerning the studied variables will be collected following the procedures and assessments plan by fulfilling the Case Report Form (CRF), in the following stages: First visit (Screening); T0 - Implants placement; TF - final prosthesis (may coincide with TL); TL - Implant loading; T6, T12, T24 and T36 - 6, 12, 24 and 36 months, respectively, after implant placement. Computed tomography (CT) scans with prototyping will be obtained from the region of interest prior to surgery, for the surgical planning and implant selection, as well as post-surgery (T0 - immediately or within 1 week after implant placement; T36) to verify zygomatic implants anchorage. Prototypes of the region of interest in the maxilla will be obtained from the initial CT scans for diagnostic purposes. Additionally, standardized digital periapical radiographs will be taken in a usual daily practice frequency, as determined by the investigator: after implants placement (T0) and during the post-operative stages (TL, TF, T6, T12, T24, and T36) to assess the osseointegration process, changes in peri-implant bone level as well as prosthetic settlement and integrity.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 16
Est. completion date March 2024
Est. primary completion date March 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 18 years of age or more; - Opposing dentition (natural teeth or teeth/implant-supported fixed restorations). Exclusion Criteria: - Symptomatology related to the facial sinuses (maxillary sinusitis, polyps or any other sinus pathologies); - Unfavorable maxillary relations; - Signs of allergy or hypersensitivity to the chemical ingredients of the material: titanium; - Presence of acute inflammatory or infectious processes in live tissue; - Unsuitable bone volume and/or quality; - Systemic complications or diseases such as bone metabolism disorders, blood clotting disorders, unsuitable healing capacity, incomplete jawbone growth, uncooperative and not motivated patient, 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, endocrine diseases, insufficient oral hygiene, and pregnancy. Additionally, subjects will be excluded if they present systemic complications that may expose them to an eventual surgical risk if submitted to surgery under general anesthesia or under local anesthesia and sedation (decompensated diabetics, immunosuppressed, patients who were submitted to radiotherapy and chemotherapy less than 4 years or who had a heart attack less than 1 year previously, patients with clinical signs and/or symptoms of sinusitis and congestion and/or nasal secretion.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Dental Implants
Dental Implants will be used according to standard routine in daily practice, according to all indications as specified by the manufacturer in the IFU (informations for use)

Locations

Country Name City State
Brazil Instituto Latino Americano de Pesquisa e Ensino Odontológico Curitiba Paraná

Sponsors (1)

Lead Sponsor Collaborator
Neodent

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Implant survival rate Implant survival will be defined as no loss of the implant at each follow-up. 36 months after implant placement.
Primary Implant success rate Evaluation of implant success will be assessed based on the criteria by Byser et al (1990). 36 months after implant placement.
Secondary Implant survival rate Implant survival will be defined as no loss of the implant at each follow-up. 6, 12, and 24 months after implant placement.
Secondary Implant success rate Evaluation of implant success will be assessed based on the criteria by Byser et al (1990). 6, 12, and 24 months after implant placement.
Secondary Prosthetic survival rate Prosthetic survival will be assessed as the prosthesis remaining in situ at each follow-up, irrespective of its condition. 12, 24, and 36 months after implant placement.
Secondary Prosthetic success rate Success will be defined as the prosthesis that remained unchanged and did not require any intervention during the entire observational period. 12, 24, and 36 months after implant placement.
Secondary Patient Satisfaction The portuguese translation of OHIP-14 [12,13] questionnaire will be used to assess Oral Health Related Quality of Life (OHRQoL), as a measure of patient satisfaction with treatment. Before implant placement and 6, 12, 24, and 36 months after implant placement.
Secondary Clinician Satisfaction 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. Immediately after implant placement, 12, 24, and 36 months after implant placement.
Secondary Adverse events related to the implant. Determined by inquiring with the patient and clinical evaluation. Immediately after implant placement, 6, 12, 24, and 36 months after implant placement.
Secondary Adverse events related to the prosthesis. Determined by inquiring with the patient and clinical evaluation. Immediately after implant placement, 6, 12, 24, and 36 months after implant placement.
Secondary Adverse events related to the surgery. Determined by inquiring with the patient and clinical evaluation. Immediately after implant placement, 6, 12, 24, and 36 months after implant placement.
Secondary Adverse events related to the oral health Determined by inquiring with the patient and clinical evaluation. Immediately after implant placement, 6, 12, 24, and 36 months after implant placement.
See also
  Status Clinical Trial Phase
Active, not recruiting NCT06408506 - In-patient Comparison of Immediately Loaded and Non-loaded Submerged and Transgingival Healed Implants Within 4 Months N/A
Active, not recruiting NCT05355792 - Multicenter Study to Evaluate the Clinical Outcome of the OmniTaper EV Implant in Single Tooth Restorations N/A
Terminated NCT00748670 - Treatment With Fixture Microthread™ in Patients With Poor Bone Quality and no Teeth in the Upper Jaw, When Using Two-Stage Surgery N/A
Completed NCT04873219 - Milled Versus Printed CAD/CAM Complete Dentures N/A
Active, not recruiting NCT04545840 - Prospective Neodent® Zirconia System Study
Completed NCT00922935 - Comparison of Early and Late Loading in the Edentulous Upper Jaw Using Cresco Prosthetic System on Straumann Implants Phase 4
Completed NCT00959530 - Comparison of Lingualized and Full Bilaterally Balanced Articulation N/A
Completed NCT00905840 - A Study to Treat Patients With Edentulous Mandibles With Two Straumann 3.3mm Diameter Bone Level Implants N/A
Completed NCT00711022 - Study on ASTRA TECH Implant System, OsseoSpeed™ Implants in Patients Missing All Teeth in the Upper Jaw, Restored With Provisional Teeth Within 24 Hours N/A
Terminated NCT00295126 - REPI : a Randomized Open Label Trial Evaluating the Use of APC in Pre-Implantation Reconstruction of Maxilla Phase 2/Phase 3
Recruiting NCT03957265 - Prospective Observational Study of SynCone® Concept Phase 1
Completed NCT01909999 - Release of Osteogenic Markers in Immediately and Non-loaded Dental Implants N/A
Completed NCT00901017 - Comparison of Synthetic Bone Substitute and a Bovine-derived Xenograft in Horizontal Bone Augmentation N/A
Completed NCT01641198 - An Implant With an Acid-etched Fixture Surface and Internal-hex Collar May Achieve Greater Osseointegration. N/A
Completed NCT03862482 - Peri-Implant Healing Around Two Different Machined-Collar Designs After 25 Years of Function N/A
Completed NCT01878331 - Long-term Study to Evaluate Different Dental Implant Alloys in Straumann 3.3mm Diameter Bone Level Implants
Completed NCT02418117 - Accuracy of Computer Guided Implant Surgery N/A
Completed NCT02107612 - Randomized Study For Minimally Invasive Splinted Implants N/A
Active, not recruiting NCT05007691 - Comparative Study of Maxillary and Mandibular Splints Used for the Treatment of Masticatory Muscle Parafunction (FEA) N/A
Completed NCT05032170 - Intraoral Scanning Accuracy in the Edentulous Mandible