Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT06123221

SINUS FLOOR WITH OSSEODENSIFICATION OR LATERAL WINDOW

Led by Federal University of Rio Grande do Sul · Updated on 2023-11-08

38

Participants Needed

1

Research Sites

208 weeks

Total Duration

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AI-Summary

What this Trial Is About

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 (tSFE) with an osseodensification system (performed according to the protocol by Huwais et al. 2018), or installed simultaneously using the lateral window technique (lSFE) with sinus lift. A blind, randomized, controlled clinical trial will be carried out with individuals over 18 years old, and with single tooth loss in the posterior maxilla, where the residual bone height (RBH) is 3 to 5 mm. The tSFE will be performed with osseodensification burs (Densa Bur, Versah, USA) using a counterclockwise motion, associated to synthetic biomaterial (hydroxyapatite and beta-tricalcium phosphate). The lSFE technique will require the sinus to be filled with the same biomaterial as the group using the other technique, and the antrostomy to be covered with a polydioxanone-based membrane. The patient's post-operatory perceptions will be evaluated by self-administered questionnaires quantifying social and professional isolation, physical appearance, duration and changes in quality of life, eating and speech, diet variations, and sleep deficiency for 2 weeks after the procedure. Pain will be assessed with the visual analogue scale (VAS). Immediately after prosthetic rehabilitation, cone beam tomography will be performed. Controls at 6 and 12 months will be performed. In these images, the marginal bone level in relation to a fixed reference point on the implants (upper part of the platform) will be measured mesially and distally in each implant, using a specific program (ImageJ - version 1.49v / NIH software - Bethesda, MD, USA). Generalized estimating equations will be used to compare the two treatments overtime. The significance level used will be 0.05.

CONDITIONS

Official Title

SINUS FLOOR WITH OSSEODENSIFICATION OR LATERAL WINDOW

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Maxillary sinuses with residual bone height between 3 mm and 5 mm
  • Residual bone ridge width suitable for 4 mm diameter implant insertion
  • Tomographic thickness of Schneider's membrane up to 5 mm in the operated area
  • Residual ridge with at least 2 mm of medullary bone and a 1:1 ratio of medullary to cortical bone
  • Adequate interarch space for prosthetic crown placement
  • Good physical health (ASA1 or ASA2 according to American Society of Anesthesiologists)
  • At least 6 months since last tooth loss in the operated region
Not Eligible

You will not qualify if you...

  • Sinus pathology
  • Heavy smoking (more than 10 cigarettes per day)
  • History of head and neck radiotherapy
  • Previous bone augmentation in targeted surgical areas
  • Any form of immunodeficiency
  • Emotional instability or psychiatric problems
  • Pregnancy
  • Current or past use of oral or injectable bisphosphonates
  • Active periodontitis with subgingival bleeding over 10%
  • Allergy to drugs or dental materials used in the study protocol

AI-Screening

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Trial Site Locations

Total: 1 location

1

Alex Haas

Porto Alegre, Rio Grande do Sul, Brazil, 90630080

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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