SINUS FLOOR WITH OSSEODENSIFICATION OR LATERAL WINDOW

Study Overview
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Brief Summary
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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.

Official Title
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COMPARISON OF IMPLANT INSTALLATION USING THE TRANSCRESTAL APPROACH WITH OSSEODENSIFICATION OR THE LATERAL WINDOW TECHNIQUE WITH SINUS LIFT: A RANDOMIZED CONTROLLED TRIAL.

Conditions
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Sinus Tract, Dental Implant Failed

Intervention / Treatment
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* Procedure: Osseodensification with Versah system
* Procedure: Lateral window


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel randomized controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Osseodensification<br>Sinus floor elevation with osseodensification and concomitant implant installation | Procedure: Osseodensification with Versah system<br>* 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<br>|
| Active Comparator: Lateral window<br>Sinus floor elevation with lateral window and concomitant implant installation | Procedure: Lateral window<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medication Diary (number of doses of Ibuprofen 600mg) | 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 | baseline | 
| Medication Diary (number of doses of Ibuprofen 600mg) | 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 | day 1 | 
| Medication Diary (number of doses of Ibuprofen 600mg) | 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 | day 2 | 
| Medication Diary (number of doses of Ibuprofen 600mg) | 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 | day 3 | 
| Medication Diary (number of doses of Ibuprofen 600mg) | 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 | day 4 | 
| Medication Diary (number of doses of Ibuprofen 600mg) | 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 | day 5 | 
| Medication Diary (number of doses of Ibuprofen 600mg) | 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 | day 6 | 
| Medication Diary (number of doses of Ibuprofen 600mg) | 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 | day 7 | 
| Medication Diary (number of doses of Ibuprofen 600mg) | 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 | day 8 | 
| Medication Diary (number of doses of Ibuprofen 600mg) | 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 | day 9 | 
| Medication Diary (number of doses of Ibuprofen 600mg) | 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 | day 10 | 
| Medication Diary (number of doses of Ibuprofen 600mg) | 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 | day 11 | 
| Medication Diary (number of doses of Ibuprofen 600mg) | 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 | day 12 | 
| Medication Diary (number of doses of Ibuprofen 600mg) | 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 | day 13 | 
| Medication Diary (number of doses of Ibuprofen 600mg) | 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 | day 14 |