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Evaluation of Implant Stability Changes in Sites Prepared with Different Osseodensification Techniques: a Prospective Observational Clinical Study

NCT06679894 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 12

Last updated 2024-11-08

No results posted yet for this study

Summary

The goal of this observational study is to compare, within a cohort of patients requiring rehabilitation in two different sites of the premolar area in the upper maxilla, the primary and secondary stability of implants placed in sites prepared using a magnetic mallet and osseodensification burs.

Conditions

  • Edentulous
  • Alveolar Process Atrophy

Interventions

PROCEDURE

Implant site preparation with osteotomes and electrified mallet

Under local anesthesia (mepivacaine HCL 2% with epinephrine1:100.000), a minimally invasive full-thickness flap was elevated to expose the alveolar crest. A pilot osteotome (100-P) was used to easily perforate the cortical plate. Subsequently, osteotomes with gradually increasing diameters were employed until the final diameter of 3.2 mm was reached. The sequence of osteotomes and their respective diameters were as follows: 1. Osteotome 100-P: At a height of 8.5 mm, the diameter was 2.2 mm; 2. Osteotome 160: At a height of 8.5 mm, the diameter was 2.8 mm; 3. Osteotome 200: At a height of 8.5 mm, the diameter was 3.2 mm. Implant (4.0x8.5 mm; Anyridge, Megagen, Gyeongbuk, South Korea) was positioned using a surgical motor. A 3 mm high transepithelial abutment (OCTA, Megagen, Gyeongbuk, South Korea) was connected to it using a torque wrench and it was tightened to 30 Ncm. Single sutures in monofilament synthetic polypropylene 4.0 were performed to close flaps around the abutment.

PROCEDURE

Implant site preparation with osseodensification drills

Under local anesthesia (mepivacaine HCL 2% with epinephrine1:100.000), a minimally invasive full-thickness flap was elevated to expose the alveolar crest. The implant site preparation was realized using osseodensification burs at a rotation speed of 1200 rpm. The osseodensification burs sequence was as follows: 1. Initial pilot hole (rotated clockwise); 2. WT1828 bur (rotated counterclockwise), 3. WT2838 bur (rotated counterclockwise). Implant (4.0x8.5 mm; Anyridge, Megagen, Gyeongbuk, South Korea) was positioned using a surgical motor. A 3 mm high transepithelial abutment (OCTA, Megagen, Gyeongbuk, South Korea) was connected to it using a torque wrench and it was tightened to 30 Ncm. Single sutures in monofilament synthetic polypropylene 4.0 were performed to close flaps around the abutment.

Sponsors & Collaborators

  • University of Trieste

    collaborator OTHER

  • International Piezosurgery Academy

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-02-15
Primary Completion
2024-07-15
Completion
2024-11-05

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 NCT06679894 on ClinicalTrials.gov