Treatment of atrophic maxilla using the NeoArch System

Not Applicable

Recruiting

• Conditions: Atrophy of the alveolar residual ridge; Jaw, Edentulous; Prostheses and Implants; K08.2

• Registration Number: RBR-3rnt7jm
• Lead Sponsor: niversidade Federal de Pelotas

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-25
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: Not specified

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

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

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Evaluation of the pro and anti-inflammatory cytokine release profile of implants during the healing process and annual follow-up for 5 years.<br><br>;Assessment of masticatory function via masticatory performance test, swallowing threshold and bite force assessments for 5 years.<br>;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.