Facultad de Medicina y Odontología de la Universitat de València
Valencia, 46010, Spain
NCT Number: NCT05286866
A randomized controlled clinical trial was conducted in the Oral Surgery Unit, Faculty of Medicine and Dentistry, University of Valencia. The research was carried out following the principles described in the Helsinki Declaration and the study was approved by the Institutional Review Board of the Ethics Committee of the University of Valencia (1937615).
Fifty patients were included in the study according to the selection criteria.The osteotomies were randomized in two groups: the control group was performed under the high-speed drilling (800 rpm) with irrigation technique and the study group under the low-speed drilling without irrigation technique (50 rpm). The randomization tool was www.randomization.com.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Valencia, 46010, Spain
Before the intervention, a preoperative orthopantomography and CBCT (Cone Beam Computerized Tomography) were taken for all the patients. Every patient was submitted a prophylactic hygiene 7 days before the intervention and 2 g of oral amoxicillin tablet 1 hour before the intervention (Clamoxyl®, GlaxoSmithKline, Madrid, Spain) was prescribed as a prophylaxis medication.
All the surgeries were performed by the same experienced operator (JCBM). The interventions were conducted under local anesthesia (4% articaine with 1: 100,000 adrenaline (Inibsa®, Lliça de Vall, Barcelona, Spain). The IPX® implant model (Nueva Galimplant S.L, Sarria, Galicia, Spain) was placed in the present study.
Surgical drills with stop (K Fres Stop ®, Nueva Galimplant S.L, Sarria, Spain) were used to prepare the osteotomies. The drilling sequence used will be: initial lance drill, followed by conical drills of 2.0 mm, 2.6 mm, 3.2 mm and 3.6 mm. The implants were apico-coronally situated at 4 mm to the mucosal margin with a torque of 35 Ncm.
The placed implants were IPX Model (Nueva Galimplant S.L., Sarria, Spain) with a 2-mm height anti-rotational abutment of one piece (Nueva Galimplant S.L, Sarria, Spain). The healing was non-submerged.
As postoperative medication 1 g of paracetamol (Bexistar®, Bacino Laboratory, Barcelona, Spain) on demand maximum every 8 hours were prescribed. Postoperative hygiene and oral care instructions were explained to the patient. A mouthwash of 0.12% chlorhexidine (GUM®, John O. Butler / Sunstar, Chicago, IL, USA) twice daily for two weeks was recommended too. The sutures were removed 7 days after surgery. Prosthetic loading will be performed 10 weeks after implant placement.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Drilling an osteotomy for placement of a dental implant
Time frame: 12 months follow-up
Measurement of peri-implant bone loss in millimeters through a periapical radiograph
Time frame: 1 day
Drilling time calculation in seconds
Time frame: 1 day
Calculation of the harvested bone between the flutes of the surgical drills in grams
Time frame: 1 day
Measurement of the pressure, distress, time, and vibration using a visual analog scale (VAS). The minimum value is "0" (nothing) and maximum value is "100" (the most one imaginable).
Time frame: 7 days
Measurement of the mouth opening, chewing, speaking, sleeping, daily routine and work through a Likert Scale. 0= nothing, 1=little bit, 2=something/sometimes, 3=Quite, 4=a lot.
Time frame: 7 days
Measurement of postoperative pain through a visual analog scale (VAS). The minimum value is "0" (no pain) and maximum value is "100" (the worst pain imaginable)
Time frame: 12 months follow-up
Probing depth measurement in millimeter (mm) using a periodontal probe
Time frame: 7 days
Measurement of postoperative inflammation through a visual analog scale (VAS). The minimum value is "0" (no inflammation) and maximum value is "100" (the worst inflammation imaginable)
University of Valencia
Other
Comparison Between High-speed Drilling With Irrigation and Low-speed Drilling: a Randomized Clinical Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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