UnknownPhase 3

One-time Abutment Placement Versus 4 Times Abutment Removal Around Dental Implants

Spain43 participantsStarted 2017-12-01

Plain-language summary

Introduction: the repeated connection and disconnection of healing abutments during dental implants´ osseointegration has been associated with significant increased peri-implant bone loss, when compared with placing the final prosthetic abutment during implant placement surgery and non-removing it ever again. Previous data from animal studies suggests that the higher the number of removals of the healing abutments, the greater the bone resorption around implants, however the evidence in humans is scarce and heterogeneous. Furthermore, this greater bone resorption has been claimed to be associated to the inflammatory status of the peri-implant soft tissues, which would be greater as a consequence of the repeated disruption of the soft-tissues attachment to the prosthetic abutment, and the hypothetical microbial contamination of the implant-abutment interphase, induced by the repeated manipulation of the prosthetic components. Objective: to evaluate the changes in peri-implant crestal bone levels between two prosthetic protocols, the control being the conventional protocol where healing abutments are placed during surgery and removed four times before the delivery of the final abutment and prostheses, and the test protocol where definitive abutments are placed immediately after implant placement and are not removed ever again. Material and methods: 80 platform switched implants will be placed in the posterior maxilla or mandible of 40 partial edentulous patients. Immediately after implant placement, patients will be randomized to receive the definitive abutment at the moment of implant placement (one abutment-one time protocol), or 12 weeks later, after removing the healing abutment four times during the confection of the final prostheses, following the conventional protocol for implant supported restorations. The day of prostheses delivery, a mucosal biopsy from the implant surrounding tissues will be taken for histomorphometric and immunohistochemical analyses of the inflammatory response of the peri-implant soft tissues. Radiographic assessment of vertical bone level changes (primary outcome), clinical status of peri-implant tissues, changes in soft tissues margin, patient related outcomes and adverse events will be assessed at 6, 12, 24 and 36 months after loading.

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: * At least two adjacent missing teeth in the posterior maxilla or mandible (positions 4 to 7) * Willing to receive implant supported fixed partial dentures * There must be a natural tooth mesial to the most proximal implant site, however free end situations will be allowed for the distal implants * Healed sites (minimum 12 weeks post-extraction) * In the case of prior bone augmentation, a minimum of 6 months of healing is required * Simultaneous bone augmentation will be allowed only for close sinus lifting Exclusion Criteria: Systemic exclusion criteria: * Medical conditions requiring prolonged use of steroids and/or medications that can interfere with bone metabolism * History of leukocyte dysfunction and deficiencies * History of neoplastic disease requiring the use of radiation or chemotherapy * History of renal failure * Metabolic disorders such as osteoporosis * History of uncontrolled endocrine disorders * Physical handicaps that would interfere with the ability to perform adequate oral hygiene * Alcoholism or drug abuse * History of immunodeficiency syndromes * Smokers of \>10 cigarettes per day, cigar equivalents or tobacco chewers * Any other condition or circumstance that, in the opinion of the investigator, would prevent completion of the study participation or interfere with the analysis of the study results, such as history of non-compliance or unreliability Local exclusion criteria: * Any kind of bone augmentation performed on the impl…

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

Changes in interproximal bone levels

Timeframe: Implantation, prosthesis loading, 6 months, 12 months, 24 months, 36 months

Trial details

NCT IDNCT05711147

SponsorUniversidad Complutense de Madrid

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12

View on ClinicalTrials.gov More Dental Implant trials