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

Bone Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05286866
• Other study ID #: 1937615
• Status: Completed
• Phase: N/A
• Start date: March 18, 2022
• Est. completion date: May 18, 2023

Study information

• Verified date: February 2024
• Source: University of Valencia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 18, 2023
• Est. primary completion date: April 18, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bone Loss

Intervention

Procedure:
• Dental implant bed preparation
Drilling an osteotomy for placement of a dental implant

Locations

Country	Name	City	State
Spain	Facultad de Medicina y Odontología de la Universitat de València	Valencia

Sponsors (3)

Lead Sponsor	Collaborator
University of Valencia	Juan Carlos Bernabeu Mira, Miguel Peñarrocha Diago

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Calculation of the elapsed drilling time	Drilling time calculation in seconds	1 day
Secondary	Analysis of the bone harvesting	Calculation of the harvested bone between the flutes of the surgical drills in grams	1 day
Secondary	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
Secondary	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
Secondary	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
Secondary	Evaluation of the peri-implant soft tissue	Probing depth measurement in millimeter (mm) using a periodontal probe	12 months follow-up
Secondary	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