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

NCT04022265 | Completed DMC

• 1 other identifier: protocol #05-2014
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Alveolar Bone Loss

Outcome Measures

Primary Outcomes (2)

• 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

  After 2 weeks to evaluate the healing prior to load with a prosthesis

• 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

  After 6 weeks, to evaluate the healing prior to load with a prosthesis

Secondary Outcomes (2)

• The percentage of total mineralized bone in contact with the implant surface.

  After 2 weeks to evaluate the healing prior to load with a prosthesis

• The percentage of total mineralized bone in contact with the implant surface.

  After 6 weeks to evaluate the healing prior to load with a prosthesis

Other Outcomes (2)

• pre-existing (old) bone, soft tissues (marrow spaces, Haversian canals, BMUs canals), bone debris/ clot remnants, and vessels

  After 2 weeks to evaluate the early haling prior to load with a prosthesis

• pre-existing (old) bone, soft tissues (marrow spaces, Haversian canals, BMUs canals), bone debris/ clot remnants, and vessels

  After 6 weeks to evaluate the early haling prior to load with a prosthesis

Study Arms (2)

Control Site -Drill site

ACTIVE COMPARATOR

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

Test site -sonic site

EXPERIMENTAL

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

Interventions

implant placement DEVICE

Full-thickness muco-periosteal flaps will be elevated, and the alveolar bone exposed to prepare the bed for the implant installation

Also known as: implant surgery, prosthesis

Control Site -Drill site; Test site -sonic site

Eligibility Criteria

• Age: 25 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• presence of systemic disorders
• chemotherapy or radiotherapy
• smokers \>10 cigarettes per day
• previous bone augmentation procedures in the same region.

Sponsors & Collaborators

• ARDEC Academy: lead

Study Sites (1)

Colombia

Cartagena, Cartagena, 5710, Colombia

Location

Related Publications (20)

• 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.

  PMID: 29148161 RESULT

• 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.

  PMID: 23231427 RESULT

• 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.

  PMID: 24524198 RESULT

• 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.

  PMID: 18474063 RESULT

• 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.

  PMID: 18280402 RESULT

• 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.

  PMID: 27527676 RESULT

• 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.

  PMID: 29843978 RESULT

• 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.

  PMID: 29583059 RESULT

• 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.

  PMID: 21682844 RESULT

• 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.

  PMID: 17397320 RESULT

• 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.

  PMID: 22024176 RESULT

• 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.

  PMID: 23837594 RESULT

• 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.

  PMID: 23217465 RESULT

• 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.

  PMID: 24777021 RESULT

• 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.

  PMID: 25171039 RESULT

• 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.

  PMID: 28623685 RESULT

• 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.

  PMID: 22056295 RESULT

• 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.

  PMID: 25220835 RESULT

• 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.

  PMID: 25109369 RESULT

• 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.

  PMID: 27214566 RESULT

MeSH Terms

Conditions

Alveolar Bone Loss

Interventions

Prostheses and Implants

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: Clinical Trial

Study Record Dates

• First Submitted: July 11, 2019
• First Posted: July 17, 2019
• Study Start: February 4, 2016
• Primary Completion: August 30, 2017
• Study Completion: December 15, 2017
• Last Updated: July 19, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)