NCT05286866

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 17, 2022

Completed
29 days until next milestone

First Posted

Study publicly available on registry

March 18, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

March 18, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 18, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 18, 2023

Completed
Last Updated

February 6, 2024

Status Verified

February 1, 2024

Enrollment Period

1.1 years

First QC Date

February 17, 2022

Last Update Submit

February 4, 2024

Conditions

Bone Loss

Keywords

dental implantlow speedirrigationdrilling

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Calculation of the elapsed drilling time

    1 day

  • Analysis of the bone harvesting

    1 day

  • Evaluation of the patient satisfaction (pressure, distress, time, vibration and anguish)

    1 day

  • Evaluation of the quality of life (mouth opening, chewing, speaking, sleeping, daily routine and work)

    7 days

  • Analysis of the postoperative pain through a visual analog scale (VAS)

    7 days

  • +2 more secondary outcomes

Study Arms (2)

Low speed drilling without irrigation

EXPERIMENTAL

The dental implants will be placed using a low-speed drilling technique without irrigation for the experimental group.

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.

Procedure: Dental implant bed preparation

Interventions

Dental implant bed preparationPROCEDURE

Drilling an osteotomy for placement of a dental implant

High speed drilling with irrigationLow speed drilling without irrigation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Facultad de Medicina y Odontología de la Universitat de València

Valencia, 46010, Spain

Location

Related Publications (1)

  • 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.

    PMID: 39950686DERIVED

MeSH Terms

Conditions

Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Titular Professor

Study Record Dates

First Submitted

February 17, 2022

First Posted

March 18, 2022

Study Start

March 18, 2022

Primary Completion

April 18, 2023

Study Completion

May 18, 2023

Last Updated

February 6, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)