Mandibular Full-arch Rehabilitation With Internal Hexagonal and Conical Connection Implants

NCT05082038 | Unknown

• 1 other identifier: CS.I.002
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

Nuvo Tapered IF (internal hexagonal connection) and CF (conical connextion) Implants were designed for the the oral functional rehabilitation using dental implants, allowing for treatment of patients with different bone qualities. The aim of the study is to confirm the long-term safety and clinical performance of implants and abutments of Nuvo IF and CF in daily dental practice setting, by means of prospective collection of clinical data in randomized clinical trial using these devices. Devices will be used , according to manufacturer indications in the IFU. Patients will be followed for 36 months after implant loading.

Conditions

Edentulous Jaw

Keywords

dental implants; oral rehabilitation

Outcome Measures

Primary Outcomes (1)

• Periimplant bone level change

  Amount of Periimplant bone level change 36 months after loading.

  up to 36 months

Secondary Outcomes (9)

• Implant survival rate

  up to 36 months

• Prosthetic survival

  6, 12, 24 and 36 months

• Soft tissue evaluation

  up to 36 months

• Patient satisfaction

  up to 36 months

• Clinician satisfaction

  up to 36 months

Study Arms (2)

Group IF

OTHER

Two Tapered IF implants will be installed in one side of the mandible

Device: Mandibular partial rehabilitation with IF Tapared implants

Group CF

OTHER

Two Tapered IF implants will be installed in the other side of the mandible

Device: Mandibular partial rehabilitation with CF Tapared implants

Interventions

Mandibular partial rehabilitation with IF Tapared implants DEVICE

2 IF Tapared Implants (Group IF) on one side of the mandible

Group IF

Mandibular partial rehabilitation with CF Tapared implants DEVICE

2 CF Tapared Implants (Group CF) on the other side of the mandible

Group CF

Eligibility Criteria

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

You may qualify if:

• Patients who qualify for mandibular rehabilitation by means of full-arch prostheses supported by two Nuvo Tapered IF implants and two Tapered CF implants

You may not qualify if:

• Contraindications according to the Instructions for Use of the device will be applied, as follows:
• 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, 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, endocrinological diseases, pregnancy.
• The research does not involve minors, or women who are pregnant or breastfeeding.

Sponsors & Collaborators

• Neodent: lead

Study Sites (1)

Mattias Sartori Consultoria Em Odontologia

Bauru, São Paulo, Brazil

Location

MeSH Terms

Conditions

Jaw, Edentulous

Condition Hierarchy (Ancestors)

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

Study Officials

• Waleska Caldas, 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

Study Record Dates

• First Submitted: September 15, 2021
• First Posted: October 18, 2021
• Study Start: September 23, 2021
• Primary Completion: May 1, 2025
• Study Completion: July 30, 2025
• Last Updated: November 13, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)