Comparison Between High-speed Drilling With Irrigation and Low-speed Drilling With Irrigation
Comparison Between High-speed Drilling With Irrigation and Low-speed Drilling: a Randomized Clinical Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Valencia, Spain, 46010
- Facultad de Medicina y Odontología de la Universitat de València
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- healthy adults, plaque and bleeding index less than 25%, sufficient bone height and width for implant placement, vestibular keratinized gingiva of at least 2 mm and stable occlusion and healthy periodontium.
Exclusion Criteria:
- any edentulous area requiring bone grafting procedures, medical conditions that contraindicate implant surgery such as severe bruxism or poor hygiene, pregnant or lactating patients, bisphosphonate therapy, patients receiving chemotherapy and radiotherapy to the head and neck, patients non-collaborators, incomplete data collection or lack of control assistance.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Low speed drilling without irrigation
The dental implants will be placed using a low-speed drilling technique without irrigation for the experimental group.
|
Drilling an osteotomy for placement of a dental implant
|
|
Active Comparator: High speed drilling with irrigation
The dental implants will be placed using a high-speed drilling technique with irrigation for the control group.
|
Drilling an osteotomy for placement of a dental implant
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluation the marginal bone loss around the dental implants
Time Frame: 12 months follow-up
|
Measurement of peri-implant bone loss in millimeters through a periapical radiograph
|
12 months follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Calculation of the elapsed drilling time
Time Frame: 1 day
|
Drilling time calculation in seconds
|
1 day
|
|
Analysis of the bone harvesting
Time Frame: 1 day
|
Calculation of the harvested bone between the flutes of the surgical drills in grams
|
1 day
|
|
Evaluation of the patient satisfaction (pressure, distress, time, vibration and anguish)
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).
|
1 day
|
|
Evaluation of the quality of life (mouth opening, chewing, speaking, sleeping, daily routine and work)
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.
|
7 days
|
|
Analysis of the postoperative pain through a visual analog scale (VAS)
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)
|
7 days
|
|
Evaluation of the peri-implant soft tissue
Time Frame: 12 months follow-up
|
Probing depth measurement in millimeter (mm) using a periodontal probe
|
12 months follow-up
|
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Analysis of the postoperative inflammation
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)
|
7 days
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1937615
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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