Bone Healing at Implants Installed in Sites Prepared Either With a Sonic Device or Drills
NCT ID: NCT04022265
Last Updated: 2019-07-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
16 participants
INTERVENTIONAL
2016-02-04
2017-12-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Bone Healing at Non-submerged Implants Installed With Different Insertion Torques.
NCT04017156
Immediate Implant Placement in the Molar Regions
NCT00226148
Conventional and Ultrasonic Implant Site Preparation
NCT03357406
Impact of Buccal Bone Thickness on Pathological Peri-implant Bone Loss: A 3-year Prospective Cohort Study
NCT02939222
Long-term Effectiveness of Contour Augmentation in Sites With Early Implant Placement
NCT03252106
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Control Site -Drill site
The control sites (Drills) will be prepared with a lanceolate drill (FS 230, Sweden / Martina), with a maximum diameter of 2.3 mm,
implant placement
Full-thickness muco-periosteal flaps will be elevated, and the alveolar bone exposed to prepare the bed for the implant installation
Test site -sonic site
test sites will be prepared with conical diamond inserts of increasing diameter (SFS99.000.014 to SFS99.000.024, Komet-Brasseler-GmbH, Germany) mounted on a sonic-air surgical instrument
implant placement
Full-thickness muco-periosteal flaps will be elevated, and the alveolar bone exposed to prepare the bed for the implant installation
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
implant placement
Full-thickness muco-periosteal flaps will be elevated, and the alveolar bone exposed to prepare the bed for the implant installation
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* height of the sinus floor ≥10 mm
* ≥ 25 years of age;
* smoking ≤10 cigarettes per day
* good general health
* no contraindication for oral surgical procedures
* not being pregnant.
Exclusion Criteria
* chemotherapy or radiotherapy
* smokers \>10 cigarettes per day
* previous bone augmentation procedures in the same region.
25 Years
80 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
ARDEC Academy
NETWORK
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Colombia
Cartagena, Cartagena, Colombia
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Atieh MA, Alsabeeha NHM, Tawse-Smith A, Duncan WJ. Piezoelectric versus conventional implant site preparation: A systematic review and meta-analysis. Clin Implant Dent Relat Res. 2018 Apr;20(2):261-270. doi: 10.1111/cid.12555. Epub 2017 Nov 16.
Bengazi F, Lang NP, Canciani E, Vigano P, Velez JU, Botticelli D. Osseointegration of implants with dendrimers surface characteristics installed conventionally or with Piezosurgery(R). A comparative study in the dog. Clin Oral Implants Res. 2014 Jan;25(1):10-5. doi: 10.1111/clr.12082. Epub 2012 Dec 12.
Vigano P, Botticelli D, Salata LA, Schweikert MT, Urbizo Velez J, Lang NP. Healing at implant sites prepared conventionally or by means of Sonosurgery (R). An experimental study in dogs. Clin Oral Implants Res. 2015 Apr;26(4):377-382. doi: 10.1111/clr.12348. Epub 2014 Feb 13.
Maurer P, Kriwalsky MS, Block Veras R, Vogel J, Syrowatka F, Heiss C. Micromorphometrical analysis of conventional osteotomy techniques and ultrasonic osteotomy at the rabbit skull. Clin Oral Implants Res. 2008 Jun;19(6):570-5. doi: 10.1111/j.1600-0501.2007.01516.x.
Schaeren S, Jaquiery C, Heberer M, Tolnay M, Vercellotti T, Martin I. Assessment of nerve damage using a novel ultrasonic device for bone cutting. J Oral Maxillofac Surg. 2008 Mar;66(3):593-6. doi: 10.1016/j.joms.2007.03.025. No abstract available.
Stacchi C, Berton F, Turco G, Franco M, Navarra CO, Andolsek F, Maglione M, Di Lenarda R. Micromorphometric analysis of bone blocks harvested with eight different ultrasonic and sonic devices for osseous surgery. J Craniomaxillofac Surg. 2016 Sep;44(9):1143-51. doi: 10.1016/j.jcms.2016.04.024. Epub 2016 Apr 22.
Amghar-Maach S, Sanchez-Torres A, Camps-Font O, Gay-Escoda C. Piezoelectric surgery versus conventional drilling for implant site preparation: a meta-analysis. J Prosthodont Res. 2018 Oct;62(4):391-396. doi: 10.1016/j.jpor.2018.04.004. Epub 2018 May 26.
Sendyk DI, de Oliveira NK, Pannuti CM, da Graca Naclerio-Homem M, Wennerberg A, Deboni MCZ. Conventional Drilling Versus Piezosurgery for Implant Site Preparation: A Meta-Analysis. J Oral Implantol. 2018 Oct;44(5):400-405. doi: 10.1563/aaid-joi-D-17-00091. Epub 2018 Mar 27.
Stacchi C, Vercellotti T, Torelli L, Furlan F, Di Lenarda R. Changes in implant stability using different site preparation techniques: twist drills versus piezosurgery. A single-blinded, randomized, controlled clinical trial. Clin Implant Dent Relat Res. 2013 Apr;15(2):188-97. doi: 10.1111/j.1708-8208.2011.00341.x. Epub 2011 Apr 19.
Preti G, Martinasso G, Peirone B, Navone R, Manzella C, Muzio G, Russo C, Canuto RA, Schierano G. Cytokines and growth factors involved in the osseointegration of oral titanium implants positioned using piezoelectric bone surgery versus a drill technique: a pilot study in minipigs. J Periodontol. 2007 Apr;78(4):716-22. doi: 10.1902/jop.2007.060285.
Geminiani A, Papadimitriou DE, Ercoli C. Maxillary sinus augmentation with a sonic handpiece for the osteotomy of the lateral window: a clinical report. J Prosthet Dent. 2011 Nov;106(5):279-83. doi: 10.1016/S0022-3913(11)00143-0.
Geminiani A, Weitz DS, Ercoli C, Feng C, Caton JG, Papadimitriou DE. A comparative study of the incidence of Schneiderian membrane perforations during maxillary sinus augmentation with a sonic oscillating handpiece versus a conventional turbine handpiece. Clin Implant Dent Relat Res. 2015 Apr;17(2):327-34. doi: 10.1111/cid.12110. Epub 2013 Jul 9.
Papadimitriou DE, Geminiani A, Zahavi T, Ercoli C. Sonosurgery for atraumatic tooth extraction: a clinical report. J Prosthet Dent. 2012 Dec;108(6):339-43. doi: 10.1016/S0022-3913(12)00169-2.
Agabiti I, Cappare P, Gherlone EF, Mortellaro C, Bruschi GB, Crespi R. New surgical technique and distraction osteogenesis for ankylosed dental movement. J Craniofac Surg. 2014 May;25(3):828-30. doi: 10.1097/SCS.0000000000000737.
Agabiti I, Bernardello F, Nevins M, Wang HL. Impacted canine extraction by ridge expansion using air scaler surgical instruments: a case report. Int J Periodontics Restorative Dent. 2014 Sep-Oct;34(5):681-7. doi: 10.11607/prd.1884.
Agabiti I, Botticelli D. Two-Stage Ridge Split at Narrow Alveolar Mandibular Bone Ridges. J Oral Maxillofac Surg. 2017 Oct;75(10):2115.e1-2115.e12. doi: 10.1016/j.joms.2017.05.015. Epub 2017 May 24.
Heinemann F, Hasan I, Kunert-Keil C, Gotz W, Gedrange T, Spassov A, Schweppe J, Gredes T. Experimental and histological investigations of the bone using two different oscillating osteotomy techniques compared with conventional rotary osteotomy. Ann Anat. 2012 Mar 20;194(2):165-70. doi: 10.1016/j.aanat.2011.10.005. Epub 2011 Oct 17.
Caneva M, Lang NP, Calvo Guirado JL, Spriano S, Iezzi G, Botticelli D. Bone healing at bicortically installed implants with different surface configurations. An experimental study in rabbits. Clin Oral Implants Res. 2015 Mar;26(3):293-9. doi: 10.1111/clr.12475. Epub 2014 Sep 15.
Ferri M, Lang NP, Angarita Alfonso EE, Bedoya Quintero ID, Burgos EM, Botticelli D. Use of sonic instruments for implant biopsy retrieval. Clin Oral Implants Res. 2015 Nov;26(11):1237-43. doi: 10.1111/clr.12466. Epub 2014 Aug 11.
Botticelli D, Lang NP. Dynamics of osseointegration in various human and animal models - a comparative analysis. Clin Oral Implants Res. 2017 Jun;28(6):742-748. doi: 10.1111/clr.12872. Epub 2016 May 23.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
protocol #05-2014
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.