Comparison Between High-speed Drilling With Irrigation and Low-speed Drilling With Irrigation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Comparison Between High-speed Drilling With Irrigation and Low-speed Drilling: a Randomized Clinical Trial

Conditions
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Bone Loss

Intervention / Treatment
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* Procedure: Dental implant bed preparation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low speed drilling without irrigation<br>The dental implants will be placed using a low-speed drilling technique without irrigation for the experimental group. | Procedure: Dental implant bed preparation<br>* Drilling an osteotomy for placement of a dental implant<br>|
| Active Comparator: High speed drilling with irrigation<br>The dental implants will be placed using a high-speed drilling technique with irrigation for the control group. | Procedure: Dental implant bed preparation<br>* Drilling an osteotomy for placement of a dental implant<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation the marginal bone loss around the dental implants | 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 | Drilling time calculation in seconds | 1 day | 
| Analysis of the bone harvesting | 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) | 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) | 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) | 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 | Probing depth measurement in millimeter (mm) using a periodontal probe | 12 months follow-up | 
| Analysis of the postoperative inflammation | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dental implant, low speed, irrigation, drilling