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Clinical Trials in Italy / NCT07019480
Active, not recruiting Observational

Influence of Implant Insertion Torque on Post-Surgical Marginal Bone Stability

NCT07019480 · tracked via the Priya Life Science Italy tracker
Sponsor
International Piezosurgery Academy
Phase
Observational
Started
2025-01-01
Last updated
2025-06-13

Condition(s) studied

Edentulous Alveolar Ridge

Investigational drug(s) / intervention(s)

implant insertion

implant insertion: Following local anesthesia (articaine 4% with epinephrine 1:100,000), a minimally invasive full-thickness flap will be elevated. Implant site preparation will be performed with twist drills and the implant will be inserted. Implant stability (ISQ) will be measured in the mesio-distal, disto-mesial, bucco-lingual, and linguo-buccal directions using a resonance frequency analysis device (Osstell Beacon, Osstell, Göteborg, Sweden) with a single-use magnetic peg specific to the implant (SmartPeg Type 07, Osstell, Göteborg, Sweden). The flap will be closed using non-resorbable monofilament sutures, and the implant will be submerged (two-stage protocol).

Study summary

The aim of this prospective, multicenter observational study is to evaluate the influence of various surgical parameters (maximum insertion torque; average insertion torque; final insertion torque; area under the torque curve; intercept and slope of the least squares regression line of the torque curve; implant stability quotient measured immediately after implant insertion) on implant osseointegration and on peri-implant marginal bone loss occurring during the first three months of submerged healing.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Indication for implant-supported prosthetic rehabilitation of single or multiple partial edentulism in one or both arches, based on accurate diagnosis and treatment planning; * The area in which the implants will be placed must have had at least 6 months of healing; * Residual alveolar ridge width ≥7 mm; * Available bone height \>9 mm at the planned implant site; * Patient aged \>18 years; * Patient does not use any removable prosthesis at the site to be treated; * Patient is able and willing to comply with the study protocol; * Patient signs the written informed consent. Exclusion Criteria: * Acute myocardial infarction within the past two months; * Uncontrolled bleeding disorders; * Uncontrolled diabetes (HBA1c \> 7.5); * History of head and/or neck radiotherapy within the past 24 months; * Immunocompromised patients, HIV positive, or undergoing chemotherapy within the past five years; * Current or previous antiresorptive therapy; * Psychological or psychiatric disorders; * Drug or alcohol abuse.

Primary outcome measure(s)

  • Implant Stability Quotient (ISQ) for the evaluation of primary stability, measured using a resonance frequency analysis (RFA) device (Osstell). — Immediately after implant placement
    Resonance Frequency Analysis (RFA) device (Osstell, Göteborg, Sweden) with the appropriate transducer for the selected abutment (Smartpeg Type 05, Osstell, Göteborg, Sweden). ISQ will be measure in the mesio-distal, disto-mesial, bucco-lingual, and linguo-buccal directions.
  • Implant primary stability in Newton — During the full course of implant insertion
    Insertion torque
  • Periapical radiograph for the assessment of peri-implant bone level (PBL) in millimeters — Immediately after implant placement
    Periapical radiograph using a customized Rinn-type film holder for each patient with the aid of a silicone index

Trial sites (1)

FacilityCityRegionStatus
University of Trieste Trieste TS

More International Piezosurgery Academy trials in Italy

Effect Of Cavitation In Post-Extractive Socket Healing Recruiting
Alveolar Ridge Preservation: Biologically-oriented Alveolar Ridge Preservation Vs Modified Periosteal Inhibition Active, not recruiting
Alveolar Ridge Preservation After Tooth Extraction Active, not recruiting
Clinical Influence of Different Surface Treatments on Implant Stabiity Recruiting
Use of Radiomics in the Evaluation of Bone Quality After Alveolar Ridge Preservation Enrolling by invitation

Other trials for the same condition

Clinical Outcomes of Immediate Implants With or Without a Volume-stable Collagen Matrix Active, not recruiting
Clinical Influence of Different Surface Treatments on Implant Stabiity Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07019480 on ClinicalTrials.gov ↗ ← All trials in Italy