Sinus TractNCT06123221
SINUS FLOOR WITH OSSEODENSIFICATION OR LATERAL WINDOW
A study testing Osseodensification with Versah system and Lateral window in people with Sinus Tract and Dental Implant Failed, run by Federal University of Rio Grande do Sul at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sinus Tract, Dental Implant Failed
- What is being tested?
- Osseodensification with Versah system and Lateral window
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Oct 2022to 1 Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- - 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;
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Alex Haas
Porto Alegre, Rio Grande do Sul, 90630080
Alex N Haas, 555191222377, alexnhaas@gmail.com
About this study
Official title: COMPARISON OF IMPLANT INSTALLATION USING THE TRANSCRESTAL APPROACH WITH OSSEODENSIFICATION OR THE LATERAL WINDOW TECHNIQUE WITH SINUS LIFT: A RANDOMIZED CONTROLLED 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.
- Conditions
- Sinus Tract, Dental Implant Failed
- Being tested
- Osseodensification with Versah system, Lateral window
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osseodensification with Versah systemProcedure or surgery
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
Lateral windowProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Osseodensification | Experimental | Sinus floor elevation with osseodensification and concomitant implant installation Receives: Procedure: Osseodensification with Versah system |
| Lateral window | Active comparator | Sinus floor elevation with lateral window and concomitant implant installation Receives: Procedure: Lateral window |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain level
visual analogue scale (VAS), ranging from "0 - no pain" to "100 - worst imaginable pain"
Measured: baseline
Pain level
visual analogue scale (VAS), ranging from "0 - no pain" to "100 - worst
Measured: day 1
Pain level
visual analogue scale (VAS), ranging from "0 - no pain" to "100 - worst
Measured: day 2
Pain level
visual analogue scale (VAS), ranging from "0 - no pain" to "100 - worst
Measured: day 3
Pain level
visual analogue scale (VAS), ranging from "0 - no pain" to "100 - worst
Measured: day 4
Pain level
visual analogue scale (VAS), ranging from "0 - no pain" to "100 - worst
Measured: day 7
Pain level
visual analogue scale (VAS), ranging from "0 - no pain" to "100 - worst
Measured: day 14
Secondary outcomes (15)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2023
- Study start1 Oct 2022
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Sinus TractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel randomized controlled trial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alex Nogueira Haas, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06123221
- Sponsor's protocol ID
- UFRGS-Cuiaba
- Status last verified
- Nov 2022
- First submitted
- 23 Nov 2022
- Last updated
- 8 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 29992594Huwais 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.
PubMed 30427961Starch-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.
PubMed 29142655Franceschetti 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.
PubMed 26749535Bacevic 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.
PubMed 33694027Starch-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.
PubMed 33748923Pikos 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.
PubMed 31067068Huwais 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.
PubMed 27741329
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPARISON OF IMPLANT INSTALLATION USING THE TRANSCRESTAL APPROACH WITH OSSEODENSIFICATION OR THE LATERAL WINDOW TECHNIQUE WITH SINUS LIFT: A RANDOMIZED CONTROLLED TRIAL.
- ClinicalTrials.gov ID
- NCT06123221
- Acronym / sponsor ID
- UFRGS-Cuiaba
- Conditions
- Sinus Tract, Dental Implant Failed
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Federal University of Rio Grande do SulUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 8 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Parallel randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Osseodensification | Experimental | Procedure: Osseodensification with Versah systemSinus floor elevation with osseodensification and concomitant implant installation |
| Lateral window | Active comparator | Procedure: Lateral windowSinus floor elevation with lateral window and concomitant implant installation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (10 listed)
- - 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Osseodensification with Versah systemAccess 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 | Procedure or surgery | Osseodensification |
| Lateral windowA 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. | Procedure or surgery | Lateral window |
Primary outcome
Pain level
Time frame: baseline
visual analogue scale (VAS), ranging from "0 - no pain" to "100 - worst imaginable pain"
Pain level
Time frame: day 1
visual analogue scale (VAS), ranging from "0 - no pain" to "100 - worst
Pain level
Time frame: day 2
visual analogue scale (VAS), ranging from "0 - no pain" to "100 - worst
Pain level
Time frame: day 3
visual analogue scale (VAS), ranging from "0 - no pain" to "100 - worst
Pain level
Time frame: day 4
visual analogue scale (VAS), ranging from "0 - no pain" to "100 - worst
Pain level
Time frame: day 7
visual analogue scale (VAS), ranging from "0 - no pain" to "100 - worst
Pain level
Time frame: day 14
visual analogue scale (VAS), ranging from "0 - no pain" to "100 - worst
15 secondary outcomes
Medication Diary (number of doses of Ibuprofen 600mg)
Time frame: baseline
Medication Diary (number of doses of Ibuprofen 600mg)
Time frame: day 1
Medication Diary (number of doses of Ibuprofen 600mg)
Time frame: day 2
Medication Diary (number of doses of Ibuprofen 600mg)
Time frame: day 3
Medication Diary (number of doses of Ibuprofen 600mg)
Time frame: day 4
Medication Diary (number of doses of Ibuprofen 600mg)
Time frame: day 5
Medication Diary (number of doses of Ibuprofen 600mg)
Time frame: day 6
Medication Diary (number of doses of Ibuprofen 600mg)
Time frame: day 7
Medication Diary (number of doses of Ibuprofen 600mg)
Time frame: day 8
Medication Diary (number of doses of Ibuprofen 600mg)
Time frame: day 9
Medication Diary (number of doses of Ibuprofen 600mg)
Time frame: day 10
Medication Diary (number of doses of Ibuprofen 600mg)
Time frame: day 11
Medication Diary (number of doses of Ibuprofen 600mg)
Time frame: day 12
Medication Diary (number of doses of Ibuprofen 600mg)
Time frame: day 13
Medication Diary (number of doses of Ibuprofen 600mg)
Time frame: day 14
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2023.
- Background: PubMed 29992594Farina 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.
- Results publication: PubMed 30427961Huwais 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.
- Results publication: PubMed 29142655Starch-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.
- Results publication: PubMed 26749535Franceschetti 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.
- Results publication: PubMed 33694027Bacevic 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.
- Results publication: PubMed 33748923Starch-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.
- Results publication: PubMed 31067068Pikos 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.
- Results publication: PubMed 27741329Huwais 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osseodensification with Versah system and Lateral window in people with Sinus Tract and Dental Implant Failed, run by Federal University of Rio Grande do Sul at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain level (time frame: baseline). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06123221, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2023.