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

Alveolar Bone Loss Clinical Trial

Official title:

Bone Healing at Implants Installed in Sites Prepared Either With a Sonic Device or Drills. A Split-mouth Histomorphometric Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04022265
• Other study ID #: protocol #05-2014
• Status: Completed
• Phase: N/A
• Start date: February 4, 2016
• Est. completion date: December 15, 2017

Study information

• Verified date: July 2019
• Source: ARDEC Academy
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose was to evaluate histomorphometrically the early healing at implants installed in sites prepared with either a sonic device or conventional drills.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 15, 2017
• Est. primary completion date: August 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alveolar Bone Loss

Intervention

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

Locations

Country	Name	City	State
Colombia	Colombia	Cartagena de Indias	Cartagena

Sponsors (1)

Lead Sponsor	Collaborator
ARDEC Academy

Country where clinical trial is conducted

Colombia, 

References & Publications (20)

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. — View 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. — View Citation

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. — View Citation

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. R — View 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. Review. — View Citation

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):1 — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

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. — View 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.1600-0501.20 — View 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. — View 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: — View Citation

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. — View Citation

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 — View 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):11 — View 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. — View Citation

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 — View Citation

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	pre-existing (old) bone, soft tissues (marrow spaces, Haversian canals, BMUs canals), bone debris/ clot remnants, and vessels	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.	After 2 weeks to evaluate the early haling prior to load with a prosthesis
Other	pre-existing (old) bone, soft tissues (marrow spaces, Haversian canals, BMUs canals), bone debris/ clot remnants, and vessels	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.	After 6 weeks to evaluate the early haling prior to load with a prosthesis
Primary	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
Primary	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	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	After 2 weeks to evaluate the healing prior to load with a prosthesis
Secondary	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	After 6 weeks to evaluate the healing prior to load with a prosthesis