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Observational Study on the Preparation of the Implant Site With Piezosurgery vs Drill: Comparison Between the Two Methods in Terms of Post-operative Pain, Surgical Times and Operational Advantages

NCT03978923 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 75

Last updated 2019-06-07

No results posted yet for this study

Summary

Purpose: Recent advances showed that ultrasonic implant site osteotomy is related with a decreased trauma and a better post operative healing of the surgical site if compared to the traditional drilling techniques. The micrometric bone cutting control and the operative advantages related to the piezoelectric approach is also characterized by a learning curve for the clinician in surgical practice and an increased operative duration of the procedure. The aim of this investigation was to compare the operative time, the post operative pain and the patients frequency of intake of painkillers in the healing period.

Methods: A total of 75 patients were treated at the Unit of Oral Surgery (Department of Medical Sciences, Surgery and Health, University of Trieste, Italy) in a split mouth model: 75 drill-inserted implants (G1) and 75 piezoelectric device- inserted implants (G2). The Visual Analogue Scale (VAS) was performed to evaluate the post-operative pain at 15 days from the surgery. The operative time and frequency of intake of painkillers was measured.

Conditions

  • Preparation of the Implant Site With Piezosurgery vs Drill

Interventions

DEVICE

preparation of the implant site with Piezosurgery vs drill

The surgery was always performed by the same operator (M.M.) to reduce the bias of the study. Loco-regional anesthesia was performed with Mepivacaine hydrochloride with 1:100000 adrenaline. For the preparation of implant sites using traditional methods, the drills were used following manufacturer's protocol by the implant system in use (WINSIX®- BioSAF IN s.r.l, Trezzano Rosa, Trezzano Rosa, Milano - Italy). For the preparation of sites was used ultrasonic device, (Surgysonic II, Esacrom S.r.l., Imola, Italy). For the final preparation and insertion of implants, 5-6 ultrasound inserts were used in sequence as follows: tip-shape 1st insert (ES012X) and 2nd insert (ES052XG), crown-shape 3rd insert (ES040), 4th insert (ES041), 5 ° insert (ES043) and 6th insert (ES044). The implant insertion was performed with a maximum torque of 35 Ncm. Finally, the cap screws were positioned, and the flaps were sutured in Vycril® 3.0.

Sponsors & Collaborators

  • University of Trieste

    lead OTHER

Eligibility

Min Age
45 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-01-01
Primary Completion
2017-12-31
Completion
2017-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03978923 on ClinicalTrials.gov