CompletedNot Applicable

Guided Bone Regeneration With Custom Made Meshes

20 participantsStarted 2013-04-09

Plain-language summary

Twenty patients underwent a guided bone regenerative procedure with the application of a virtually projected customized mesh as containment and stabilizer of particulate bone graft. The entity of bone volume reconstructed after healing were digitally analysed on radiological imaging and expressed in volumetric data and in percentage of what planned before the operation. This datum was correlated with predictors variables potentially affecting the final results. As secondary outcome the implant results after the prosthetic loading was evaluated in terms of survival, success and complication.

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: * The presence of horizontal and vertical alveolar defects in both jaws, inadequate for the placement of at least two fixtures, even ≤6 mm long ones; * ≥ 18 years; * informed consent signed. Exclusion Criteria: * acute or chronic infections in the head and neck; * smoking \>10 cigarettes per day; * uncontrolled diabetes (glycated hemoglobin level \> 7 mg/dL); * a history of radiation therapy in the head or neck region; * current antitumor chemotherapy; * liver, blood, or kidney disease; * immunosuppression; * everyday corticosteroid use; * pregnancy; * inflammatory and autoimmune disease of the oral cavity; * poor oral hygiene and motivation

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

Bone regeneration volumes

Timeframe: 6 months after surgery

Trial details

NCT IDNCT04942223

SponsorUniversity of Bologna

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-05-15

View on ClinicalTrials.gov More The Presence of Horizontal and Vertical Alveolar Defects in Both Jaws, Inadequate for the Placement of at Least Two Fixtures, Even ≤6 mm Long Ones trials