SINUS FLOOR WITH OSSEODENSIFICATION OR LATERAL WINDOW

Not Applicable

Recruiting

• Conditions: Dental Implant Failed; Sinus Tract
• Interventions: Procedure: Lateral window; Procedure: Osseodensification with Versah system

• Registration Number: NCT06123221
• Lead Sponsor: Federal University of Rio Grande do Sul

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 (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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-01
• Status Verified: 2022-11
• Study First Submitted: 2022-11-23
• Study First Submitted QC: 2023-11-03
• Last Update Submitted: 2023-11-03
• Study First Posted: 2023-11-08
• Last Update Posted: 2023-11-08
• Primary Completion: 2026-10-01
• Study Completion: 2026-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

• 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 Criteria

• • 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lateral window	Lateral window	Sinus floor elevation with lateral window and concomitant implant installation
Osseodensification	Osseodensification with Versah system	Sinus floor elevation with osseodensification and concomitant implant installation

Primary Outcome Measures

Name	Time	Method
Pain level	day 14	visual analogue scale (VAS), ranging from "0 - no pain" to "100 - worst

Secondary Outcome Measures

Name	Time	Method
Medication Diary (number of doses of Ibuprofen 600mg)	day 14	Rescue anti-inflammatory drug dosage (i.e. number of ibuprofen 600 mg tablets), and name of other types of drugs taken as of the day of surgery up to the 14th postoperative day, recorded daily in a medication diary

Trial Locations

Locations (1)

Alex Haas; 🇧🇷 Porto Alegre, Rio Grande Do Sul, Brazil