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NCT Number: NCT05286866

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Facultad de Medicina y Odontología de la Universitat de València

Valencia, 46010, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dental implant bed preparation

Procedure

Drilling an osteotomy for placement of a dental implant

Primary outcomes

  1. 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

Secondary outcomes

  1. Calculation of the elapsed drilling time

    Time frame: 1 day

    Drilling time calculation in seconds

  2. Analysis of the bone harvesting

    Time frame: 1 day

    Calculation of the harvested bone between the flutes of the surgical drills in grams

  3. 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).

  4. 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.

  5. 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)

  6. Evaluation of the peri-implant soft tissue

    Time frame: 12 months follow-up

    Probing depth measurement in millimeter (mm) using a periodontal probe

  7. 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)

Sponsors and collaborators

Lead sponsor

University of Valencia

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 18, 2022
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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