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出境医 / 临床实验 / Bone Healing at Implants Installed in Sites Prepared Either With a Sonic Device or Drills

Bone Healing at Implants Installed in Sites Prepared Either With a Sonic Device or Drills

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.

Condition or disease Intervention/treatment Phase
Alveolar Bone Loss Device: implant placement Not Applicable

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
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Clinical Trial
Masking: Triple (Participant, Investigator, Outcomes 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.
Primary Purpose: Treatment
Official Title: Bone Healing at Implants Installed in Sites Prepared Either With a Sonic Device or Drills. A Split-mouth Histomorphometric Randomized Controlled Trial
Actual Study Start Date : February 4, 2016
Actual Primary Completion Date : August 30, 2017
Actual Study Completion Date : December 15, 2017
Arms and Interventions
Arm Intervention/treatment
Active Comparator: 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,
 Device: implant placement
Full-thickness muco-periosteal flaps will be elevated, and the alveolar bone exposed to prepare the bed for the implant installation
Other Name: implant surgery, prosthesis
Experimental: 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
 Device: implant placement
Full-thickness muco-periosteal flaps will be elevated, and the alveolar bone exposed to prepare the bed for the implant installation
Other Name: implant surgery, prosthesis
Outcome Measures
Primary Outcome Measures :
  1. New bone in contact with the implant surface [ Time Frame: After 2 weeks to evaluate the healing prior to load with a prosthesis ]
    The percentages of new bone in contact with the implant surface will be evaluated in the histomorphometric analysis

  2. New bone in contact with the implant surface [ Time Frame: After 6 weeks, to evaluate the healing prior to load with a prosthesis ]
    The percentages of new bone in contact with the implant surface will be evaluated in the histomorphometric analysis


Secondary Outcome Measures :
  1. The percentage of total mineralized bone in contact with the implant surface. [ Time Frame: After 2 weeks to evaluate the healing prior to load with a prosthesis ]
    The percentages of new bone in contact with the implant surface will be evaluated in the histomorphometric analysis

  2. The percentage of total mineralized bone in contact with the implant surface. [ Time Frame: After 6 weeks to evaluate the healing prior to load with a prosthesis ]
    The percentages of new bone in contact with the implant surface will be evaluated in the histomorphometric analysis


Other Outcome Measures:
  1. pre-existing (old) bone, soft tissues (marrow spaces, Haversian canals, BMUs canals), bone debris/ clot remnants, and vessels [ Time Frame: After 2 weeks to evaluate the early haling prior to load with a prosthesis ]
    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.

  2. pre-existing (old) bone, soft tissues (marrow spaces, Haversian canals, BMUs canals), bone debris/ clot remnants, and vessels [ Time Frame: After 6 weeks to evaluate the early haling prior to load with a prosthesis ]
    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.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   25 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations

Locations
Layout table for location information
Colombia
Colombia
Cartagena de Indias, Cartagena, Colombia, 5710
Sponsors and Collaborators
ARDEC Academy
Tracking Information
First Submitted Date  ICMJE July 11, 2019
First Posted Date  ICMJE July 17, 2019
Last Update Posted Date July 19, 2019
Actual Study Start Date  ICMJE February 4, 2016
Actual Primary Completion Date August 30, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 13, 2019)
  • New bone in contact with the implant surface [ Time Frame: After 2 weeks to evaluate the healing prior to load with a prosthesis ]
    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 [ Time Frame: After 6 weeks, to evaluate the healing prior to load with a prosthesis ]
    The percentages of new bone in contact with the implant surface will be evaluated in the histomorphometric analysis
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 13, 2019)
  • The percentage of total mineralized bone in contact with the implant surface. [ Time Frame: After 2 weeks to evaluate the healing prior to load with a prosthesis ]
    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. [ Time Frame: After 6 weeks to evaluate the healing prior to load with a prosthesis ]
    The percentages of new bone in contact with the implant surface will be evaluated in the histomorphometric analysis
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 13, 2019)
  • pre-existing (old) bone, soft tissues (marrow spaces, Haversian canals, BMUs canals), bone debris/ clot remnants, and vessels [ Time Frame: After 2 weeks to evaluate the early haling prior to load with a prosthesis ]
    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.
  • pre-existing (old) bone, soft tissues (marrow spaces, Haversian canals, BMUs canals), bone debris/ clot remnants, and vessels [ Time Frame: After 6 weeks to evaluate the early haling prior to load with a prosthesis ]
    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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Bone Healing at Implants Installed in Sites Prepared Either With a Sonic Device or Drills
Official Title  ICMJE Bone Healing at Implants Installed in Sites Prepared Either With a Sonic Device or Drills. A Split-mouth Histomorphometric Randomized Controlled Trial
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Clinical Trial
Masking: Triple (Participant, Investigator, Outcomes 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.
Primary Purpose: Treatment
Condition  ICMJE Alveolar Bone Loss
Intervention  ICMJE Device: implant placement
Full-thickness muco-periosteal flaps will be elevated, and the alveolar bone exposed to prepare the bed for the implant installation
Other Name: implant surgery, prosthesis
Study Arms  ICMJE
  • Active Comparator: 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,
    Intervention: Device: implant placement
  • Experimental: 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
    Intervention: Device: implant placement
Publications *
  • 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. Review.
  • Bengazi F, Lang NP, Canciani E, Viganò P, Velez JU, Botticelli D. Osseointegration of implants with dendrimers surface characteristics installed conventionally or with Piezosurgery®. 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.
  • Viganò P, Botticelli D, Salata LA, Schweikert MT, Urbizo Velez J, Lang NP. Healing at implant sites prepared conventionally or by means of Sonosurgery ®. 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, Jaquiéry 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.
  • 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, Sánchez-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. Review. Erratum in: J Prosthodont Res. 2020 Oct;64(4):520-521.
  • Sendyk DI, de Oliveira NK, Pannuti CM, da Graça Naclério-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.
  • 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, Capparè 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, Götz 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 13, 2019) 		16
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 15, 2017
Actual Primary Completion Date August 30, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Colombia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04022265
Other Study ID Numbers  ICMJE protocol #05-2014
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Will be shared after publication
Responsible Party ARDEC Academy
Study Sponsor  ICMJE ARDEC Academy
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account ARDEC Academy
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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