Internal vs. External Connection in Screw-retained Multi-units Bridges With Cad/Cam Milled Co/Cr … (NCT02789956) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Internal vs. External Connection in Screw-retained Multi-units Bridges With Cad/Cam Milled Co/Cr Framework (ISUS-Atlantis)
Italy48 participantsStarted 2016-07
Plain-language summary
The aim of this study is to evaluate:
Primary objective The primary objective of the present study is to evaluate the marginal bone level changes when partially edentulous patients, treated with implants, received a multiunits screw retained fixed dental prosthesis with a Co/Cr milled framework with an Internal or External connection.
Secondary objective
1. Overall survival rate.
2. Soft tissue status by assessment of bleeding on probing (BoP) and probing pocket depth (PPD) at baseline and after 1,3,5 years.
3. Prosthetic survival rates including screw or abutment loosening, framework or veneer fractures.
Who can participate
Age range
18 Years – 90 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:
* Age \> 18 years.
* Willingness to comply with all study requirements and to sign the IC.
* Systemic health.
* Compliance with good oral hygiene.
* Patients with at least 2 teeth to replace in any side of the jaws.
Exclusion Criteria:
* Patients treated with implant with bone defects associated with severe knife-edge ridges.
* Patients treated with bone defects resulting from tumor resection.
* Tobacco abuse (\> 10 cigarettes/day).
* Severe renal and liver disease.
* History of radiotherapy in the head and neck region.
* Chemotherapy for treatment of malignant tumors at the time of the surgical procedure.
* Uncontrolled diabetes.
* Active periodontal disease involving the residual opposite dentition.
* Mucosal disease, such as lichen planus, in the areas to be treated.
* Poor oral hygiene.
* Non-compliant patients.
* Situations judged inconvenient(by the investigator) for the surgical treatment.
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
Marginal bone resorption in millimeter from the implant to the bone crest.
Timeframe: 1 year
2
Marginal bone resorption in millimeter from the implant to the bone crest.
Timeframe: 3 year
3
Marginal bone resorption in millimeter from the implant to the bone crest.