Dental Implant Failed, Sinus Tract
Conditions
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.
Interventions
PROCEDUREOsseodensification with Versah system
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
PROCEDURELateral window
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.
Sponsors
Federal University of Rio Grande do Sul
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Intervention model description
Parallel randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain level | baseline | visual analogue scale (VAS), ranging from 0 - no pain to 100 - worst imaginable pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Medication Diary (number of doses of Ibuprofen 600mg) | baseline | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incidence of postoperative signs and symptoms | day 0 (night), +1, +2, +3, +4, +7 and +14; | Incidence of swelling, nausea, bruising, nasal discharge/bleeding, nasal stuffiness, bad taste/smell |
| Willingness to undergo the same type of surgery | recorded on day +14 | a 4-point rating scale ranging from no problem to repeat surgery if needed to I will never have this type of surgery again. |
| Clinical Outcomes | 7 and 14 days after surgery | Membrane perforation (yes or no) will be evaluated during the transoperative period. In addition, the following clinical outcomes will be evaluated: Face edema (yes or no); * Facial hematoma (yes or no); * Presence of suppuration; * Suture dehiscence. |
| Level of discomfort | as recorded on day 0 (night), +1, +2, +3, +4, +7, and +14, | 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 |
| Peri-implant clinical examinations | 1 and 12 months after the installation of the prosthesis | probing depth in millimeters will be evaluated at six sites per implant (mesiobuccal, buccal, distobuccal, and mesiolingual/palatal, lingual/palatal, distolingual/palatal). |
| Tomographic outcomes | 1 and 12 months after the installation of the prosthesis | The images will be used to measure the marginal bone level mesially and distally in each implant, in relation to a fixed reference point on the implants (upper part of the platform), using a specific program (ImageJ) |
| Cinical evaluation of Implant failure | through study completion, an average of 18 months | Implant loss may occur during the phase of osseointegration (early) or at a later time when the previously achieved osseointegration is lost (late). Implant loss defined by lack of osseointegration represented by mobility, and will be assessed at throughout the entire search |
| Limitations in daily functions | as recorded on day 0 (night), +1, +2, +3, +4, +7 and + 14 | 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 ); |
Countries
Brazil
Outcome results
None listed