Status:

RECRUITING

SINUS FLOOR WITH OSSEODENSIFICATION OR LATERAL WINDOW

Lead Sponsor:

Federal University of Rio Grande do Sul

Conditions:

Sinus Tract

Dental Implant Failed

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

This study will compare patient-reported outcomes, as well as the type and incidence of complications, and bone marginal loss after 12 months in implants installed using the transcrestal approach (tSF...

Eligibility Criteria

Inclusion

  • Maxillary sinuses that have residual bone height between at least 3 mm and 5 mm;
  • Width of the residual bone ridge that allows the insertion of an implant with a diameter of 4 mm;
  • Tomographic thickness of Schneider's membrane with a maximum of 5 mm in the region to be operated;
  • Residual ridge with ≥2 mm of medullary bone in the bucco-palatal direction, with a 1/1 ratio of medullary and cortical bone to achieve predictable plastic expansion;
  • Patients with adequate interarch space for placement of the prosthetic crown;
  • Good physical health status (ASA1 and ASA2, according to the Physical Status Classification System - American Society of Anesthesiologists);
  • At least 6 months since the last tooth loss in the region to be operated;

Exclusion

  • \- Those with sinus pathology;
  • Heavy smokers (more than 10 cigarettes a day);
  • Those with a history of head and neck radiotherapy;
  • Those who have already undergone bone augmentation in any of the targeted surgical areas;
  • Immunodeficiency of any nature;
  • Emotional instability and psychiatric problems;
  • Pregnancy;
  • Current use of oral bisphosphonates or history of using injectable bisphosphonate;
  • Patients with active periodontitis defined by the presence of subgingival bleeding greater than 10%;
  • Documented allergy to drugs or dental materials involved in the experimental protocol.

Key Trial Info

Start Date :

October 1 2022

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

October 1 2026

Estimated Enrollment :

38 Patients enrolled

Trial Details

Trial ID

NCT06123221

Start Date

October 1 2022

End Date

October 1 2026

Last Update

November 8 2023

Active Locations (1)

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1

Alex Haas

Porto Alegre, Rio Grande do Sul, Brazil, 90630080