CompletedNot Applicable

Validation Use of Implants and Abutments With Biologically Oriented Preparation Technique

Spain40 participantsStarted 2017-06-15

Plain-language summary

This randomized clinical trial aims to validate and to establish indications for using implants with biological oriented preparation technique (I.B.O.P.T.) for implant supported prosthetic treatment as an option looking for better stability and control of associated soft and hard tissues compared with conventional implants and conventional abutments with finishing lines preparation technique.

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: * Male or female ≥18 years old. * Need for implant-supported fixed prosthesis in the posterior area of the upper or lower jaw (up to 2 implants and three units bridge); * Adequate bone quality and quantity at the implant site to allow the insertion of Sweden and Martina Premium or Prama (Due Carrare, Padova, Italy), of diameters 3.8, 4.25 or 5 mm and lengths between 10 and 13 mm. * Healthy ASA type I and II patients. * Full-mouth plaque index \<20. Exclusion Criteria: * Smokers ≥10 cigarettes/day. * Presence of implant-supported restorations adjacent to the study site. * Active periodontitis defined as the presence of pockets with probing depth (PD) ≥5 mm and bleeding on probing (BoP). * Systemic medication that contraindicates surgery (bisphosphonates or steroid therapy). * Uncontrolled diabetes. * Severe bruxism. * Pregnancy. * Previous history of radiotherapy.

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

Marginal bone level

Timeframe: Baseline to 12-months follow-up

Soft tissue volumetric analysis

Timeframe: Baseline to 12-motnhs follow-up

Trial details

NCT IDNCT05051839

SponsorUniversidad Complutense de Madrid

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-06-15

View on ClinicalTrials.gov More Dental Implant-Abutment Design trials