UnknownNot Applicable

Implant/Abutment Module Stability of Original vs Compatible Connections

Spain40 participantsStarted 2018-01-08

Plain-language summary

Together with materials and type of retention, the stability of the implant abutment connection represents one of the key factor for the success rate of an implant supported restoration. The recent diffusion of high quality and easy to use CAD/CAM systems has contributed to market launch of a number of competing companies that offer the so called "clonical" or "compatible" restorative components. Although they are claimed to be identical, the original abutments are supposed to present maximum accuracy and consequently lower microleakage. The aim of the present randomized controlled trial will be to analyze the implant abutment junction stability comparing implant-supported crowns restored with original components and compatible non-original abutments. The hypothesis is that original components will present significantly better stability than non-original abutments.

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: * Any healthy patient scheduled for an implant-supported restoration will be considered for inclusion in this study, independently of the implant and prosthetic protocols used. Exclusion Criteria: * general medical contraindications to oral surgery (American Society of Anesthesiologist, ASA, class III or IV), * patients \<18 years of age, * smoking habit (\>10 cigarettes/day), * sites with acute infection or requiring regenerative procedures, * Full Mouth Plaque Score * Full Mouth Bleeding Score \>25 %, * pregnant and lactating.

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

Biological complications

Timeframe: 1 year

Biomechanical complications

Timeframe: 1 year

Trial details

NCT IDNCT03524872

SponsorUniversity of Valencia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-12

Contact for this trial

David Peñarrocha Oltra

0034649952560 david.penarrocha@uv.es

View on ClinicalTrials.gov More Bone Loss, Alveolar trials