Effect of the Abutment-Prosthesis Connection on Marginal Bone Loss and Gingival Sealing Around De… (NCT05883202) | Clinical Trial Compass
SuspendedNot Applicable
Effect of the Abutment-Prosthesis Connection on Marginal Bone Loss and Gingival Sealing Around Dental Implants
Stopped: No researcher available to conduct the study.
Spain40 participantsStarted 2023-07-10
Plain-language summary
In dental implant restoration, available literature demonstrates the advantage of using tall abutments, with a change of diameter with respect to the implant and a conical internal connection in the abutment-implant gap. However, for multiple restorations, the abutment-prosthesis connection has not been studied in detail. The "multi-unit" systems, both standard and brand specific, have either a flat or butt joint or an cone. In any case, both are external connection systems. Recently, an internal-type abutment-prosthesis connection system has been developed. Although it is proving its usefulness in single restorations, its use in multiple restorations compared to traditional systems has not been studied.
Therefore, taking into account all of the above, the present study has the overall objective of analyzing marginal bone loss (MBL) and adaptation of soft tissues by comparing a multiple prosthesis system of the "external, flat" type versus an external system of the "internal, conical" type.
Who can participate
Age range
18 Years – 75 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:
* Kennedy class I or II (unilateral or bilateral free end) or III (posterior intermediate edentulous section) mandibular requiring 2 implants to restore at least 2 molars, 2 molars and 1 premolar, or 2 premolars and 1 molar.
* Possibility of placing a transgingival abutment at least 2 mm high.
Exclusion criteria:
* Need for simultaneous bone augmentation.
* Heavy smokers (\>10 cigarettes/day).
* Uncontrolled type 1 or 2 diabetes (HgA1c\>8).
* Known autoimmune or inflammatory disease.
* Serious blood disorders, such as hemophilia or leukemia.
* Local or systemic infection that may compromise normal healing (e.g., extensive periapical pathology).
* Liver or kidney dysfunction/failure.
* Currently receiving cancer treatment or within 18 months from completion of radio- or chemotherapy.
* Long-term history of oral bisphosphonates use (i.e., 10 years or more).
* History of intravenous bisphosphonates.
* Long-term (\>3 months) history of antibiotics or drugs known to alter the inflammation and/or immunological system 3 months before inclusion.
* Severe osseous diseases (e.g., Paget disease of bone).
* Pregnant women or nursing mothers.
* Not able or not willing to follow instructions related to the study procedures.
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.