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Treatment of atrophic maxilla using the NeoArch System

Clinical and functional performance of fixed implant retained prostheses in the maxilla using the All-on-4 protocol (NeoArch): an interventional clinical study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-3rnt7jm
Enrollment
Unknown
Registered
2020-11-25
Start date
2020-03-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrophy of the alveolar residual ridge

Interventions

A total of 16 total edentulous patients diagnosed with atrophic maxilla will receive the installation of 4 dental implants in the edentulous maxilla according to the All-on-4 surgical protocol (Neo-ar
D25.339.312

Sponsors

Universidade Federal de Pelotas
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients of both gender in a balanced number without age criteria; totally edentulous patients rehabilitated with mandibular overdentures and upper complete dentures with maxillary bone atrophy, instability and/or dissatisfaction with their upper complete denture; no self-reported systemic health problems; do not use any medication in the last 3 months that affects the immune response; adequate bone quality and availability without the need of bone graft

Exclusion criteria

Exclusion criteria: Volunteers with uncontrolled diabetes or hypertension; hemorrhagic disorders; serious systemic diseases; compromised immune system; history of radiotherapy in the head or neck

Design outcomes

Primary

MeasureTime frame
Clinical performance of straight and angled implants measured by peri-implant health indicators, marginal bone loss, stability, success and survival of implants during 5 years.

Secondary

MeasureTime frame
Evaluation of the pro and anti-inflammatory cytokine release profile of implants during the healing process and annual follow-up for 5 years. ;Assessment of masticatory function via masticatory performance test, swallowing threshold and bite force assessments for 5 years. ;Assessment of satisfaction and quality of life related to oral health using Dental Impact on Daily Living (DIDL) and OHIP-Edent questionaries for 5 years.

Countries

Brazil

Contacts

Public ContactFernanda Faot

Universidade Federal de Pelotas

fernanda.faot@gmail.com+55-053-3260-2831

Outcome results

None listed

Source: REBEC (via WHO ICTRP)