SINUS FLOOR WITH OSSEODENSIFICATION OR LATERAL WINDOW
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFederal University of Rio Grande do Sul
About this trial
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
This trial accepts healthy volunteersQualifiers
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;
Disqualifiers
- 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;
Trial design
Design model
Parallel
Treatments tested in this trial
Osseodensification with Versah system
Procedure/SurgeryAccess 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
Lateral window
Procedure/SurgeryA 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.
Treatment groups
38 Participants
are divided into 2 treatment groupsGroup A: OsseodensificationExperimental treatment 1 intervention
Group B: Lateral windowActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Pain level
visual analogue scale (VAS), ranging from "0 - no pain" to "100 - worst imaginable pain"
Time frame
baseline2
Pain level
visual analogue scale (VAS), ranging from "0 - no pain" to "100 - worst
Time frame
day 13
Pain level
visual analogue scale (VAS), ranging from "0 - no pain" to "100 - worst
Time frame
day 24
Pain level
visual analogue scale (VAS), ranging from "0 - no pain" to "100 - worst
Time frame
day 3Secondary outcomes
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
Time frame
baseline2
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
Time frame
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
Time frame
day 24
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
Time frame
day 3Other outcomes
1
Level of discomfort
Level of discomfort as recorded on a 5-point rating scale ranging from "no discomfort"; "little discomfort"; "discomfort"; "a lot of discomfort" and "very high discomfort"
Time frame
as recorded on day 0 (night), +1, +2, +3, +4, +7, and +14,2
Limitations in daily functions
Limitations in daily functions (i.e. swallowing, breathing, continuing daily activities, eating, speaking, opening the mouth), on a 5-point rating scale ranging from "no limitations" to "unable to eat all kinds of food" (for the item "eat"), and from "no difficulty" to "extreme difficulty" (for the other items );
Time frame
as recorded on day 0 (night), +1, +2, +3, +4, +7 and + 143
Incidence of postoperative signs and symptoms
Incidence of swelling, nausea, bruising, nasal discharge/bleeding, nasal stuffiness, bad taste/smell
Time frame
day 0 (night), +1, +2, +3, +4, +7 and +14;4
Willingness to undergo the same type of surgery
a 4-point rating scale ranging from "no problem to repeat surgery if needed" to "I will never have this type of surgery again."
Time frame
recorded on day +14Sponsors and contacts
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Source ClinicalTrials.gov