Bone LossNCT05286866
Comparison Between High-speed Drilling With Irrigation and Low-speed Drilling With Irrigation
A study testing Dental implant bed preparation in people with Bone Loss, run by University of Valencia at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bone Loss
- What is being tested?
- Dental implant bed preparation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 18 Mar 2022to 18 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Facultad de Medicina y Odontología de la Universitat de València
Valencia, 46010
About this study
Official title: 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.
Read the 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.
- Conditions
- Bone Loss
- Being tested
- Dental implant bed preparation
- Keywords
- dental implant, low speed, irrigation, drilling
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental implant bed preparationProcedure or surgery
Drilling an osteotomy for placement of a dental implant
| Study group | Role | What they receive |
|---|---|---|
| Low speed drilling without irrigation | Experimental | The dental implants will be placed using a low-speed drilling technique without irrigation for the experimental group. Receives: Procedure: Dental implant bed preparation |
| High speed drilling with irrigation | Active comparator | The dental implants will be placed using a high-speed drilling technique with irrigation for the control group. Receives: Procedure: Dental implant bed preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation the marginal bone loss around the dental implants
Measurement of peri-implant bone loss in millimeters through a periapical radiograph
Measured: 12 months follow-up
Secondary outcomes (7)
Calculation of the elapsed drilling time
Drilling time calculation in seconds
Measured: 1 day
Analysis of the bone harvesting
Calculation of the harvested bone between the flutes of the surgical drills in grams
Measured: 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).
Measured: 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.
Measured: 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)
Measured: 7 days
Evaluation of the peri-implant soft tissue
Probing depth measurement in millimeter (mm) using a periodontal probe
Measured: 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)
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2022
- Study start18 Mar 2022
- Primary completion18 Apr 2023
- Study completion18 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bone LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Peñarrocha Oltra, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05286866
- Sponsor's protocol ID
- 1937615
- Status last verified
- Jul 2026
- First submitted
- 17 Feb 2022
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bernabeu-Mira JC, Penarrocha-Diago M, Canullo L, Camacho-Alonso F, Rojo-Sanchis J, Penarrocha-Oltra D. Peri-Implant Marginal Bone Changes Using High-Speed Drilling With Irrigation Versus Low-Speed Drilling Without Irrigation: A Randomized Clinical Trial With 12 Months of Follow-Up. Clin Oral Implants Res. 2025 Jun;36(6):698-709. doi: 10.1111/clr.14416. Epub 2025 Feb 14.
PubMed 39950686
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between High-speed Drilling With Irrigation and Low-speed Drilling: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05286866
- Acronym / sponsor ID
- 1937615
- Conditions
- Bone Loss
- Keywords
- dental implant, low speed, irrigation, drilling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 18 Mar 2022 (actual)
- Primary completion
- 18 Apr 2023 (actual)
- Study completion
- 18 May 2023 (actual)
- First posted
- 18 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low speed drilling without irrigation | Experimental | Procedure: Dental implant bed preparationThe dental implants will be placed using a low-speed drilling technique without irrigation for the experimental group. |
| High speed drilling with irrigation | Active comparator | Procedure: Dental implant bed preparationThe dental implants will be placed using a high-speed drilling technique with irrigation for the control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dental implant bed preparationDrilling an osteotomy for placement of a dental implant | Procedure or surgery | High speed drilling with irrigation, Low speed drilling without irrigation |
Primary outcome
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
7 secondary outcomes
Calculation of the elapsed drilling time
Time frame: 1 day
Analysis of the bone harvesting
Time frame: 1 day
Evaluation of the patient satisfaction (pressure, distress, time, vibration and anguish)
Time frame: 1 day
Evaluation of the quality of life (mouth opening, chewing, speaking, sleeping, daily routine and work)
Time frame: 7 days
Analysis of the postoperative pain through a visual analog scale (VAS)
Time frame: 7 days
Evaluation of the peri-implant soft tissue
Time frame: 12 months follow-up
Analysis of the postoperative inflammation
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Derived from this study: PubMed 39950686Bernabeu-Mira JC, Penarrocha-Diago M, Canullo L, Camacho-Alonso F, Rojo-Sanchis J, Penarrocha-Oltra D. Peri-Implant Marginal Bone Changes Using High-Speed Drilling With Irrigation Versus Low-Speed Drilling Without Irrigation: A Randomized Clinical Trial With 12 Months of Follow-Up. Clin Oral Implants Res. 2025 Jun;36(6):698-709. doi: 10.1111/clr.14416. Epub 2025 Feb 14.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dental implant bed preparation in people with Bone Loss, run by University of Valencia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation the marginal bone loss around the dental implants (time frame: 12 months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05286866, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.