Bone Healing at Implants Installed in Sites Prepared Either With a Sonic Device or Drills
Primary Purpose
Alveolar Bone Loss
Status
Completed
Phase
Not Applicable
Locations
Colombia
Study Type
Interventional
Intervention
implant placement
Sponsored by
About this trial
This is an interventional treatment trial for Alveolar Bone Loss
Eligibility Criteria
Inclusion Criteria:
- presence of an edentulous atrophic zone in the posterior segment of the maxilla
- 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:
- presence of systemic disorders
- chemotherapy or radiotherapy
- smokers >10 cigarettes per day
- previous bone augmentation procedures in the same region.
Sites / Locations
- Colombia
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control Site -Drill site
Test site -sonic site
Arm Description
The control sites (Drills) will be prepared with a lanceolate drill (FS 230, Sweden / Martina), with a maximum diameter of 2.3 mm,
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
Outcomes
Primary Outcome Measures
New bone in contact with the implant surface
The percentages of new bone in contact with the implant surface will be evaluated in the histomorphometric analysis
New bone in contact with the implant surface
The percentages of new bone in contact with the implant surface will be evaluated in the histomorphometric analysis
Secondary Outcome Measures
The percentage of total mineralized bone in contact with the implant surface.
The percentages of new bone in contact with the implant surface will be evaluated in the histomorphometric analysis
The percentage of total mineralized bone in contact with the implant surface.
The percentages of new bone in contact with the implant surface will be evaluated in the histomorphometric analysis
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04022265
Brief Title
Bone Healing at Implants Installed in Sites Prepared Either With a Sonic Device or Drills
Official Title
Bone Healing at Implants Installed in Sites Prepared Either With a Sonic Device or Drills. A Split-mouth Histomorphometric Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
February 4, 2016 (Actual)
Primary Completion Date
August 30, 2017 (Actual)
Study Completion Date
December 15, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ARDEC Academy
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose was to evaluate histomorphometrically the early healing at implants installed in sites prepared with either a sonic device or conventional drills.
Detailed Description
Sixteen volunteer patients will be recruited. Two titanium mini-implants will be installed in the distal segments of the maxilla in recipient sites prepared with either a sonic device or conventional drills. Biopsies containing the mini-implants will be retrieved after 2 weeks in eight patients, and after 6 weeks in the other eight patients. Histomorphometric analyses will be performed
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alveolar Bone Loss
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Clinical Trial
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Each patient will receive two mini-implants, installed in recipient sites prepared in the distal segments of the maxilla either with a sonic device or drills. The two recipient sites will be selected prior the surgery, while the type of site preparation will be randomly decided. A researcher, neither involved in the selection of the patients nor in the surgical and prosthetic treatment, carried out electronically the randomization (randomization.com). Sealed opaque envelopes will be prepared and opened at the time of surgery and they will report the position of the sonic sites so that the surgeon will be masked about site preparation type until the surgery. The site will be indicated as mesial or distal position if the two sites will be located in the same quadrant of the maxilla, or as right or left if they will be located in opposite quadrants of the maxilla.
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Site -Drill site
Arm Type
Active Comparator
Arm Description
The control sites (Drills) will be prepared with a lanceolate drill (FS 230, Sweden / Martina), with a maximum diameter of 2.3 mm,
Arm Title
Test site -sonic site
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
implant placement
Other Intervention Name(s)
implant surgery, prosthesis
Intervention Description
Full-thickness muco-periosteal flaps will be elevated, and the alveolar bone exposed to prepare the bed for the implant installation
Primary Outcome Measure Information:
Title
New bone in contact with the implant surface
Description
The percentages of new bone in contact with the implant surface will be evaluated in the histomorphometric analysis
Time Frame
After 2 weeks to evaluate the healing prior to load with a prosthesis
Title
New bone in contact with the implant surface
Description
The percentages of new bone in contact with the implant surface will be evaluated in the histomorphometric analysis
Time Frame
After 6 weeks, to evaluate the healing prior to load with a prosthesis
Secondary Outcome Measure Information:
Title
The percentage of total mineralized bone in contact with the implant surface.
Description
The percentages of new bone in contact with the implant surface will be evaluated in the histomorphometric analysis
Time Frame
After 2 weeks to evaluate the healing prior to load with a prosthesis
Title
The percentage of total mineralized bone in contact with the implant surface.
Description
The percentages of new bone in contact with the implant surface will be evaluated in the histomorphometric analysis
Time Frame
After 6 weeks to evaluate the healing prior to load with a prosthesis
Other Pre-specified Outcome Measures:
Title
pre-existing (old) bone, soft tissues (marrow spaces, Haversian canals, BMUs canals), bone debris/ clot remnants, and vessels
Description
The percentages of pre-existing (old) bone, soft tissues (marrow spaces, Haversian canals, BMUs canals), bone debris/ clot remnants and vessels in contact with the implant surface will be evaluated in the histomorphometric analysis.
Time Frame
After 2 weeks to evaluate the early haling prior to load with a prosthesis
Title
pre-existing (old) bone, soft tissues (marrow spaces, Haversian canals, BMUs canals), bone debris/ clot remnants, and vessels
Description
The percentages of pre-existing (old) bone, soft tissues (marrow spaces, Haversian canals, BMUs canals), bone debris/ clot remnants and vessels in contact with the implant surface will be evaluated in the histomorphometric analysis.
Time Frame
After 6 weeks to evaluate the early haling prior to load with a prosthesis
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
presence of an edentulous atrophic zone in the posterior segment of the maxilla
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:
presence of systemic disorders
chemotherapy or radiotherapy
smokers >10 cigarettes per day
previous bone augmentation procedures in the same region.
Facility Information:
Facility Name
Colombia
City
Cartagena de Indias
State/Province
Cartagena
ZIP/Postal Code
5710
Country
Colombia
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Will be shared after publication
Citations:
PubMed Identifier
29148161
Citation
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.
Results Reference
result
PubMed Identifier
23231427
Citation
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.
Results Reference
result
PubMed Identifier
24524198
Citation
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.
Results Reference
result
PubMed Identifier
18474063
Citation
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.
Results Reference
result
PubMed Identifier
18280402
Citation
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.
Results Reference
result
PubMed Identifier
27527676
Citation
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.
Results Reference
result
PubMed Identifier
29843978
Citation
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. Erratum In: J Prosthodont Res. 2020 Oct;64(4):520-521.
Results Reference
result
PubMed Identifier
29583059
Citation
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.
Results Reference
result
PubMed Identifier
21682844
Citation
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.
Results Reference
result
PubMed Identifier
17397320
Citation
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.
Results Reference
result
PubMed Identifier
22024176
Citation
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.
Results Reference
result
PubMed Identifier
23837594
Citation
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.
Results Reference
result
PubMed Identifier
23217465
Citation
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.
Results Reference
result
PubMed Identifier
24777021
Citation
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.
Results Reference
result
PubMed Identifier
25171039
Citation
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.
Results Reference
result
PubMed Identifier
28623685
Citation
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.
Results Reference
result
PubMed Identifier
22056295
Citation
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.
Results Reference
result
PubMed Identifier
25220835
Citation
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.
Results Reference
result
PubMed Identifier
25109369
Citation
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.
Results Reference
result
PubMed Identifier
27214566
Citation
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.
Results Reference
result
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Bone Healing at Implants Installed in Sites Prepared Either With a Sonic Device or Drills
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