Clinical trial NCT06123221: SINUS FLOOR WITH OSSEODENSIFICATION OR LATERAL WINDOW
Official title: COMPARISON OF IMPLANT INSTALLATION USING THE TRANSCRESTAL APPROACH WITH OSSEODENSIFICATION OR THE LATERAL WINDOW TECHNIQUE WITH SINUS LIFT: A RANDOMIZED CONTROLLED TRIAL.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sinus Tract
Dental Implant Failed
Lead sponsor: Federal University of Rio Grande do Sul
Sponsor class: OTHER
First posted: 2023-11-08
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel randomized controlled trial
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Pain level
timeFrame: baseline
measure: Pain level
timeFrame: day 1
measure: Pain level
timeFrame: day 2
measure: Pain level
timeFrame: day 3
measure: Pain level
timeFrame: day 4
measure: Pain level
timeFrame: day 7
measure: Pain level
timeFrame: day 14
Secondary outcomes:
measure: Medication Diary (number of doses of Ibuprofen 600mg)
timeFrame: baseline
measure: Medication Diary (number of doses of Ibuprofen 600mg)
timeFrame: day 1
measure: Medication Diary (number of doses of Ibuprofen 600mg)
timeFrame: day 2
measure: Medication Diary (number of doses of Ibuprofen 600mg)
timeFrame: day 3
measure: Medication Diary (number of doses of Ibuprofen 600mg)
timeFrame: day 4
measure: Medication Diary (number of doses of Ibuprofen 600mg)
timeFrame: day 5
measure: Medication Diary (number of doses of Ibuprofen 600mg)
timeFrame: day 6
measure: Medication Diary (number of doses of Ibuprofen 600mg)
timeFrame: day 7
measure: Medication Diary (number of doses of Ibuprofen 600mg)
timeFrame: day 8
measure: Medication Diary (number of doses of Ibuprofen 600mg)
timeFrame: day 9
measure: Medication Diary (number of doses of Ibuprofen 600mg)
timeFrame: day 10
measure: Medication Diary (number of doses of Ibuprofen 600mg)
timeFrame: day 11
measure: Medication Diary (number of doses of Ibuprofen 600mg)
timeFrame: day 12
measure: Medication Diary (number of doses of Ibuprofen 600mg)
timeFrame: day 13
measure: Medication Diary (number of doses of Ibuprofen 600mg)
timeFrame: day 14
Other outcomes:
measure: Level of discomfort
timeFrame: as recorded on day 0 (night), +1, +2, +3, +4, +7, and +14,
measure: Limitations in daily functions
timeFrame: as recorded on day 0 (night), +1, +2, +3, +4, +7 and + 14
measure: Incidence of postoperative signs and symptoms
timeFrame: day 0 (night), +1, +2, +3, +4, +7 and +14;
measure: Willingness to undergo the same type of surgery
timeFrame: recorded on day +14
measure: Clinical Outcomes
timeFrame: 7 and 14 days after surgery
measure: Cinical evaluation of Implant failure
timeFrame: through study completion, an average of 18 months
measure: Peri-implant clinical examinations
timeFrame: 1 and 12 months after the installation of the prosthesis
measure: Peri-implant clinical examinations
timeFrame: 1 and 12 months after the installation of the prosthesis
measure: Tomographic outcomes
timeFrame: 1 and 12 months after the installation of the prosthesis
Locations:
city: Porto Alegre
country: Brazil
facility: Alex Haas
state: Rio Grande Do Sul
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.