UnknownNot Applicable

Guided Surgery for Horizontal Bone Augmentation

Belgium28 participantsStarted 2019-05-28

Plain-language summary

The aim of the research project is to develop a novel protocol for guided bone regeneration (GBR) and assess whether such a patient specific 3D printed guide can improve the accuracy of the resulting bone augmentation when compared to conventional freehand protocols. This study will be an open, prospective, randomized controlled clinical trial. A total of 28 healthy adult patients requiring bone augmentation of an edentulous site with adjacent teeth prior to implant placement will be included in a clinical trial. All patients have to fulfill all inclusion criteria and none of the exclusion criteria. The total study duration for the patient will be around 7 months, from inclusion to final follow-up. A virtual plan representing the ideal shape of the augmentation will be prepared. Bone augmentation guides (molds) will be designed and 3D printed for each case. These molds will encompass the defect and the desired augmentation (including the overfill compensating for the expected resorption) on the buccal aspect, leaving a small access space on the coronal aspect of the defect which will be used to insert the grafting material. Additionally, they will have holes near the mesial, distal and apical edges allowing for fixation of the barrier membrane using pin placement when the mold is in position. Finally, they will extend to the occlusal surface of teeth adjacent to the defect site in order to allow precise positioning and will have a protrusion (handle) on the buccal aspect allowing for easier handling and positioning. The trial will have two groups, a freehand group where conventional bone augmentation surgery will be performed and the clinician will determine the shape of the graft manually, and a guided group where the guide described above will be used. A 50:50 mixture of DBBM and autogenous bone will be used for both groups, resulting in a composite graft. The graft will be covered by a resorbable collagen membrane.

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: * presence of at least one site requiring bone augmentation prior to or simultaneously with implant placement; * the above mentioned site should have adjacent teeth both mesially and distally; * a history of edentulism in the area of implant treatment of at least 3 months; * provision of informed consent. Exclusion Criteria: * unlikely to be able to comply with the study procedures, as judged by the investigator; * untreated periodontal disease; * known or suspected current malignancy; * history of chemotherapy within 5 years prior to study; * history of radiation in the head and neck region; * history of other metabolic bone diseases; * a medical history that makes bone augmentation or implant insertion unfavorable; * need for systemic corticosteroids; * current or previous use of intravenous bisphosphonates; * current or previous use of oral bisphosphonates; * history of bone grafting and/or sinus lift in the planned implant area; * present alcohol and/or drug abuse; * involvement in the planning and conduct of the study; * previous enrolment in the present study.

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

Accuracy of resulting graft, immediately post-operatively.

Timeframe: Immediately after surgery

Accuracy of resulting graft, 6 months after surgery

Timeframe: Six months after surgery

Trial details

NCT IDNCT05282862

SponsorKU Leuven

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-03

Contact for this trial

Mihai Tarce

+32 16 332483 mihai.tarce@kuleuven.be

View on ClinicalTrials.gov More Edentulous Alveolar Ridge Atrophy trials