Influence of Implant Insertion Torque on Post-Surgical Marginal Bone Stability (NCT07019480) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Influence of Implant Insertion Torque on Post-Surgical Marginal Bone Stability
Italy150 participantsStarted 2025-01-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Implant Stability Quotient (ISQ) for the evaluation of primary stability, measured using a resonance frequency analysis (RFA) device (Osstell).
Timeframe: Immediately after implant placement
2
Implant primary stability in Newton
Timeframe: During the full course of implant insertion
3
Periapical radiograph for the assessment of peri-implant bone level (PBL) in millimeters