SINUS FLOOR WITH OSSEODENSIFICATION OR LATERAL WINDOW

NCT06123221 | Recruiting DMC

• 1 other identifier: UFRGS-Cuiaba
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Sinus Tract; Dental Implant Failed

Outcome Measures

Primary Outcomes (7)

• Pain level

  visual analogue scale (VAS), ranging from "0 - no pain" to "100 - worst imaginable pain"

  baseline

• Pain level

  visual analogue scale (VAS), ranging from "0 - no pain" to "100 - worst

  day 1

• Pain level

  visual analogue scale (VAS), ranging from "0 - no pain" to "100 - worst

  day 2

• Pain level

  visual analogue scale (VAS), ranging from "0 - no pain" to "100 - worst

  day 3

• Pain level

  visual analogue scale (VAS), ranging from "0 - no pain" to "100 - worst

  day 4

• Pain level

  visual analogue scale (VAS), ranging from "0 - no pain" to "100 - worst

  day 7

• Pain level

  visual analogue scale (VAS), ranging from "0 - no pain" to "100 - worst

  day 14

Secondary Outcomes (15)

• Medication Diary (number of doses of Ibuprofen 600mg)

  baseline

• Medication Diary (number of doses of Ibuprofen 600mg)

  day 1

• Medication Diary (number of doses of Ibuprofen 600mg)

  day 2

• Medication Diary (number of doses of Ibuprofen 600mg)

  day 3

• Medication Diary (number of doses of Ibuprofen 600mg)

  day 4

Other Outcomes (9)

• Level of discomfort

  as recorded on day 0 (night), +1, +2, +3, +4, +7, and +14,

• Limitations in daily functions

  as recorded on day 0 (night), +1, +2, +3, +4, +7 and + 14

• Incidence of postoperative signs and symptoms

  day 0 (night), +1, +2, +3, +4, +7 and +14;

Study Arms (2)

Osseodensification

EXPERIMENTAL

Sinus floor elevation with osseodensification and concomitant implant installation

Procedure: Osseodensification with Versah system

Lateral window

ACTIVE COMPARATOR

Sinus floor elevation with lateral window and concomitant implant installation

Procedure: Lateral window

Interventions

Osseodensification with Versah system PROCEDURE

Access to the bone crest will be performed through a slightly palatinized crestal incision, and a full-thickness mucoperiosteal flap will be elevated. Implant site preparation will be performed according to the bone densification drilling sequence established by the Densah® technique protocol

Osseodensification

Lateral window PROCEDURE

A full-thickness mucoperiosteal flap will be elevated. The lateral window will be made with a spherical diamond drill (number 8) at 20,000 rpm. The mesiodistal and apicocoronal dimensions of the lateral access window to the sinus will be measured in all the participants using a caliper. Sinus membrane elevation will be performed with manual instruments.

Lateral window

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Federal University of Rio Grande do Sul: lead

Study Sites (1)

Alex Haas

Porto Alegre, Rio Grande do Sul, 90630080, Brazil

RECRUITING

Related Publications (8)

• Farina R, Franceschetti G, Travaglini D, Consolo U, Minenna L, Schincaglia GP, Riccardi O, Bandieri A, Maietti E, Trombelli L. Morbidity following transcrestal and lateral sinus floor elevation: A randomized trial. J Clin Periodontol. 2018 Sep;45(9):1128-1139. doi: 10.1111/jcpe.12985. Epub 2018 Aug 3.

  PMID: 29992594 BACKGROUND

• Huwais S, Mazor Z, Ioannou AL, Gluckman H, Neiva R. A Multicenter Retrospective Clinical Study with Up-to-5-Year Follow-up Utilizing a Method that Enhances Bone Density and Allows for Transcrestal Sinus Augmentation Through Compaction Grafting. Int J Oral Maxillofac Implants. 2018 Nov/Dec;33(6):1305-1311. doi: 10.11607/jomi.6770.

  PMID: 30427961 RESULT

• Starch-Jensen T, Jensen JD. Maxillary Sinus Floor Augmentation: a Review of Selected Treatment Modalities. J Oral Maxillofac Res. 2017 Sep 30;8(3):e3. doi: 10.5037/jomr.2017.8303. eCollection 2017 Jul-Sep.

  PMID: 29142655 RESULT

• Franceschetti G, Rizzi A, Minenna L, Pramstraller M, Trombelli L, Farina R. Patient-reported outcomes of implant placement performed concomitantly with transcrestal sinus floor elevation or entirely in native bone. Clin Oral Implants Res. 2017 Feb;28(2):156-162. doi: 10.1111/clr.12774. Epub 2016 Jan 8.

  PMID: 26749535 RESULT

• Bacevic M, Compeyron Y, Lecloux G, Rompen E, Lambert F. Intraoperative and postoperative outcomes of sinus floor elevation using the lateral window technique versus the hydrodynamic transalveolar approach: a preliminary randomized controlled trial. Clin Oral Investig. 2021 Sep;25(9):5391-5401. doi: 10.1007/s00784-021-03847-2. Epub 2021 Mar 10.

  PMID: 33694027 RESULT

• Starch-Jensen T, Bruun NH. Patient's perception of recovery after osteotome-mediated sinus floor elevation with Bio-Oss collagen compared with no grafting material: a randomized single-blinded controlled trial. Int J Implant Dent. 2021 Mar 22;7(1):20. doi: 10.1186/s40729-021-00302-5.

  PMID: 33748923 RESULT

• Pikos MA, Miron RJ. To Drill or to Densify? Clinical Indications for the Use of Osseodensification. Compend Contin Educ Dent. 2019 May;40(5):276-281; quiz 282.

  PMID: 31067068 RESULT

• Huwais S, Meyer EG. A Novel Osseous Densification Approach in Implant Osteotomy Preparation to Increase Biomechanical Primary Stability, Bone Mineral Density, and Bone-to-Implant Contact. Int J Oral Maxillofac Implants. 2017 Jan/Feb;32(1):27-36. doi: 10.11607/jomi.4817. Epub 2016 Oct 14.

  PMID: 27741329 RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Parallel randomized controlled trial

Study Record Dates

• First Submitted: November 23, 2022
• First Posted: November 8, 2023
• Study Start: October 1, 2022
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: November 8, 2023

Record last verified: 2022-11

Locations

BR (1)