Bone Healing at Implants Installed in Sites Prepared Either With a Sonic Device or Drills. A Split-mouth Histomorphometric Randomized Controlled Trial
Phase: NA
Conditions: Alveolar Bone Loss
Sponsor: ARDEC Academy

 
1 
Bone healing at implants installed in sites prepared either with 
a sonic device or drills. A split-mouth histomorphometric 
randomized controlled trial. 
Brief title: Bone healing at implant installed in sites prepared with either a 
sonic device or drills 
Shigeru Sakuma, Adriano Piattelli, Niccolò Baldi, Mauro Ferri, Giovanna 
Iezzi & Daniele Botticelli 
 
Shigeru Sakuma, Niccolò Baldi, Daniele Botticelli, ARDEC Academy, Ariminum 
Odontologica, Rimini, Italy 
Adriano Piattelli, Giovanna Iezzi, Department of Medical, Oral and Biotechnological 
Sciences, University of Chieti-Pescara, Chieti, Italy 
Mauro Ferri, Corporación Universitaria Rafael Nuñez, Cartagena de Indias, Colombia 
Running Head: sonic device for implant site preparation 
Key words: human study, histometry, morphometry, dental implants, bone, bone-to-
implant contact, bone density 
 
Corresponding author:  
Daniele Botticelli, BMBS, PhD, Dentist 
Viale Giovanni Pascoli 67, 47923 Rimini (RN), Italy 
Tel.: +39-0541-393444, Fax: +39-0541-397044, E-mail: daniele.botticelli@ardec.it 
 
 
 
 
 
July 17th 2017 
 

 
2 
 
Abstract 
Purpose: to evaluate histomorphometrically the early healing at implants installed in sites 
prepared with either a sonic device or conventional drills. 
Material and methods: 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. 
 
Key words: Bone-to-implant contact; bone density; dental implants; histometry; histology; 
sonic device. 
 
 
 
 
 

 
3 
INTRODUCTION 
A systematic review with meta-analysis compared the use of a piezoelectric device and 
drills for implant site preparation.1 Both technical approaches presented similar results 
regarding implant failure and marginal bone level changes. However, a longer time for site 
preparation was required for the piezoelectric device compared to the drills. was and 
operating time. 
The healing at implants installed in sites prepared using conventional drills to sites 
prepared with either a piezoelectric device or a sonic device was studied in animal 
experiments.2,3 No differences in osseointegration were found in both studies. The use of 
piezoelectric or sonic devices has become widespread during the last years due to the 
precision offered during the cutting procedures of these devices, the reduced risk of 
damaging soft tissues, and the clear view of the surgical sites offered by this device during 
the preparation.4-6 
Piezoelectric devices have been largely studied and compared with the use of drills for 
implant site preparation.7,8 In a randomized controlled clinical study,9 gain in implant 
stability was faster in sites prepared with piezosurgery compared to twist drills, while no 
differences in survival rate were found. As support to this finding, an experimental study in 
mini pigs,10 showed that sites prepared with piezosurgery presented a more advanced 
osteogenesis compared to those prepared with drills. 
Comparatively to the piezoelectric devices, lesser amount of clinical11-18 and experimental 
researches3 have been performed to evaluate the sonic devices. Nevertheless, similar 
advantages of the piezoelectric instruments are offered by the sonic devices in term of 
surgical precision, clear view of the surgical field, and low risk of possible damages of the 
surrounding soft tissues.3 Moreover, the sonic devices have been claimed to produce a 
similar increase of the temperature during the procedure of that produced by drills, and 
lower than that produced by piezoelectric instruments.19 

 
4 
Experimental histological data comparing sonic devices and conventional drills are still 
scares and histological data from human are not available. Hence, the aim of the present 
study will be to evaluate histomorphometrically the early healing at implants installed in 
sites prepared with either a sonic device or conventional drills. 
The hypothesis will be that the preparation of an implant recipient site using a sonic 
instrument might produce different osseointegration compared to a conventional site 
preparation using drills. 
 
MATERIALS & METHODS  
Patient selection 
In the present split-mouth histomorphometric randomized controlled trial, sixteen patients 
will be included. The Declaration of Helsinki on medical protocols and ethics will be 
followed. The protocol has the approval of the Ethical Committee of the Corporación 
Universitária Rafael Núñez, Cartagena de Indias, Colombia (protocol #05-2014; 8 October 
2014). In the same institution will be performed all treatments. After having exhaustively 
illustrated the surgical procedures and the possible complications, a written informed 
consent will be signed by the patients. The study will be reported according to the 
CONSORT guidelines. 
To calculate a suitable sample, data from an animal experiment in dogs performed by the 
same research group were used.3 In that experiment, implant site preparations was carried 
out either with a similar sonic device used in the present study or drills, and a difference of 
7.3% in bone-to-implant contact was seen in favor of the sonic groups with an n=6. 
Considering a possible higher variability in humans and possible dropouts, a sample n=8 
pairs of subjects is considered sufficient to reject the null hypothesis that this response 
difference is zero, with a power 0.8 and α=0.05, as evaluated using PS Power and Sample 
Size Calculations, (William D. Dupont and Walton D. Plummer). Two groups of 8 

 
5 
volunteers will be randomly formed and planned for biopsies retrieval after either 2 or 6 
weeks of healing. 
The patients included in the present study have to satisfy the following inclusion criteria:  
(i) 
presence of an edentulous atrophic zone in the posterior segment of the maxilla 
(ii) 
height of the sinus floor ≥10 mm 
(iii) 
 ≥ 25 years of age;  
(iv) 
smoking ≤10 cigarettes per day 
(v) 
good general health 
(vi) 
no contraindication for oral surgical procedures 
(vii) 
not being pregnant.  
The following exclusion criteria will be adopted: 
(i) 
presence of systemic disorders 
(ii) 
chemotherapy or radiotherapy 
(iii) 
smokers >10 cigarettes per day 
(iv) 
previous bone augmentation procedures in the same region. 
Moreover, caries and periodontal conditions will be evaluated and, if any of these 
pathologies are present, they will be treated before starting the study. 
 
Device 
Titanium screw-shaped mini-implants, 4 mm long and 2.5 mm in diameter and with a 
ZirTi® surface (Sweden & Martina, Due Carrare, Padua, Italy) will be used. Surface 
features of the implants were previously reported.20 
 
Randomization and allocation concealment 
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 

 
6 
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. 
 
Clinical procedures 
All surgical procedures will be performed by an expert surgeon. Local anesthesia will be 
provided and crestal and releasing incisions will be carried out. Full-thickness muco-
periosteal flaps will be elevated, and the alveolar bone exposed. The control sites (Drills) 
will be prepared with a lanceolate drill (FS 230, Sweden / Martina), with a maximum 
diameter of 2.3 mm, while the 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 (Sonosurgery® TKD, Calenzano, Fi 
- Italy). The dimensions of the final drill and of the final sonic device allowed the 
preparation of recipient sites of similar dimensions (about 2.3-2.4 mm in the coronal 
aspect). The mini-implants will be subsequently installed, a cover screw will be placed on 
the top of the mini-implants, and the flaps will be sutured allowing a fully submerged 
healing. 
Antibiotics (amoxicillin 875 mg/clavulanic acid 125 mg twice a day for 6 days), non-
steroidal anti-inflammatory drugs as needed (Ibuprofen 400 mg), and mouth rinses with 
0.12% chlorhexidine three times a day for 10 days will be prescribed. The sutures will be 
removed after 7 days, and the patients will be enrolled in a maintenance recall. Biopsies 

 
7 
including the mini-implants will be retrieved after 2 or 6 weeks of healing, paying attention 
to keep the implant in an eccentric position within the trephine, to reduce the dimension of 
the biopsy and maintaining sufficient tissue for analysis, as previously described.21 
 
Histological preparation of the biopsies 
The biopsies will be washed in saline solution and immediately stored in 10% buffered 
formalin. The histological process will be performed in the laboratory facilities at the 
University of Chieti-Pescara, Italy. The biopsies will be not removed from the trephine. 
They will be dehydrated in an ascending series of alcohol, and subsequently embedded in 
a glycol-methacrylate resin (Technovit® 7200 VLC; Kulzer, Wehrheim, Germany). Once 
the polymerization will be finalized, the biopsies will be sectioned following the longitudinal 
axis of the samples using precision diamond disks, and specimens of about 150 microns 
of width will be obtained. The specimens will be afterwards ground to about 30 µm of width 
and stained with acid fuchsine and toluidine blue. 
 
Histomorphometric evaluation 
The histomorphometric evaluation will be performed twice by a blinded author, and mean 
values will be used.  A code will be reported on the histological slides so that no 
indications will be available on the site preparation procedures and period of healing.  All 
histological analyses will be carried out in ARDEC Academy, Italy, using an Eclipse Ci 
microscope (Nikon Corporation, Tokyo, Japan) connected to a digital video camera (Digital 
Sight DS-2Mv, Nikon Corporation, Tokyo, Japan). To carry out measurements, the 
software NIS-Elements D 4.10 (Laboratory Imaging, Nikon Corporation, Tokyo, Japan) will 
be used. The percentages of newly formed bone (new bone), pre-existing bone (old bone), 
bone debris/ clot remnants (debris), and marrow spaces (soft tissue) in contact with the 
implant surface will be evaluated at x200 magnification from the most coronal contact of 

 
8 
bone to the implant surface (B) to the apical extension of osseointegration (A). The total 
mineralized bone will be calculated as sum of new and old bone.  
Morphometric measurements (tissues density) will be performed, identifying the same 
tissues above indicated plus vessels, in a region included between B and A, and at a 
distance from the implant surface of about 0.4 mm. For this purpose, a point counting 
procedure will be used applying a lattice with squares of 50 microns superposed over the 
histological slides, using a magnification of x200. 
The interception point for new and pre-existing bone in contact with the implant surface will 
be calculated and expressed in days of occurrence and bone-to-implant contact 
percentage, according to Botticelli et al. (2017).22 
 
Outcomes Measures  
 
Healing after two weeks 
Primary outcome: 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. 
Timeframe: After 2 weeks, to evaluate the early healing after surgery. 
Secondary outcome: The percentage of total mineralized bone in contact with the implant 
surface. 
Description: The total mineralized bone will be assessed as sum of new and old bone as 
evaluated in the histomorphometric analysis. 
Timeframe: After 2 weeks, to evaluate the early healing after surgery. 
Other pre-specified outcomes: pre-existing (old) bone, soft tissues (marrow spaces, 
Haversian canals, BMUs canals), bone debris/ clot remnants, and vessels. 

 
9 
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. 
Timeframe: After 2 weeks, to evaluate the early healing after surgery. 
 
Healing after 6 weeks 
Primary outcome: 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. 
Timeframe: After 6 weeks, to evaluate the healing prior to load with a prosthesis. 
Secondary outcome: The percentage of total mineralized bone in contact with the implant 
surface. 
Description: The total mineralized bone will be assessed as sum of new and old bone as 
evaluated in the histomorphometric analysis. 
Timeframe: After 6 weeks, to evaluate the healing prior to load with a prosthesis. 
Other pre-specified outcomes: 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. 
Timeframe: After 6 weeks, to evaluate the haling prior to load with a prosthesis. 
 
Data analysis 
Mean values and standard deviations as well as 25th, 50th (median), and 75th percentiles 
will be calculated for each outcome variable. Means, standard deviations and 95% upper 
and lower confidence interval of the difference between the means of sonic and drill sites 

 
10
will be calculated for each variable analyzed for both histometric and morphometric 
analyses. 
The primary variable will be newly formed bone (new bone) in contact with the implant 
surface. Total mineralized bone, calculated as sum of new and old pre-existing bone, in 
contact with the implant surface will be considered as secondary variable.  
A Wilcoxon test will be used to analyze differences between sonic and drill groups for all 
outcomes. The level of significance will be set at α 0.05.  
With an explorative aim, a Mann-Whitney test will be used to analyze the difference in new 
bone and total mineralize bone between 2 and 6 weeks of healing.  
 
ACKNOWLEDGEMENTS 
This study will be economically supported by ARDEC Academy, Ariminum Odontologica 
Srl, Rimini, Italy. 
There are no conflicts of interest with the material presented. 

 
11
REFERENCES 
1. 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. 
2. Bengazi F, Lang NP, Canciani E, Vigano` 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;25:10–5. 
3. 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;26:377-382. 
4. 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. 
5. 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. 
6. 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. 
7. 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;62:391-396. 
8. Sendyk DI, Oliveira NK, Pannuti CM, Naclério-Homem MDG, Wennerberg A, Zindel 
Deboni MC. Conventional drilling versus piezosurgery for implant site preparation: a meta-
analysis. J Oral Implantol 2018;44:400-405. 

 
12
9. 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. 
10. 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. 
11. Agabiti I. Split crest osteotomy with low- frequency vibrating tools: A case report. 
Dental Cadmos 2011;79:1–8;   
12. 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;106:279–283. 
13. 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;17:327–334. 
14. Papadimitriou DE, Geminiani A, Zahavi T, Ercoli C. Sonosurgery for atraumatic tooth 
extraction: a clinical report. J Prosthet Dent 2012;108:339–343.  
15. 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;25:828-830. 
16. 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;34:681-687. 

 
13
17. Agabiti I, Botticelli D. Two-stage ridge split at narrow alveolar mandibular bone ridges. 
J Oral Maxillofac Surg 2017;75:2115.e1-2115.e12. 
18. Agabiti I, Botticelli D. Transcrestal sinus floor elevation performed twice with collagen 
sponges and using a sonic instrument. J Oral Science Rehabilitation 2016;2:40–47. 
19. Heinemann F, Hasan I, Kunert-Keil C, et al. Experimental and histological 
investigations of the bone using two different oscillating osteotomy techniques compared 
with conventional rotary osteotomy. Ann Anat 2012;194:165–170. 
20. 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;26:293-299. 
21. 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;26:1237-1243. 
22. Botticelli D, Lang NP. Dynamics of osseointegration in various human and animal 
models - a comparative analysis. Clin Oral Implants Res 2017;28:742-748.