Comparison of Two Collagen Membranes for Bone Augmentation Around Dental Implants Restored with M… (NCT06724783) | Clinical Trial Compass
RecruitingPhase 4
Comparison of Two Collagen Membranes for Bone Augmentation Around Dental Implants Restored with Monolithic Zirconia Single Crowns
Switzerland68 participantsStarted 2023-06-30
Plain-language summary
The goal of this randomized controlled clinical trial is to compare the use of two covering collagen membranes in a bone augmentation procedure around single implants and to assess three different veneering approaches on crowns in patients lacking a single tooth in the esthetic zone.
The main aims include:
1. Bone stability, i.e. the difference in the bone defect depth 4 months after bone augmentation
2. The occurrence of ceramic restoration chipping at the inserted single crowns after 5 years.
Participants will receive an implant with simultaneous bone augmentation using the bone particles and a covering collagen membrane. After the healing period, they will receive a crown restoration on the implant.
In the surgical part, researchers will compare the commonly used collagen membrane with the compressed (stronger) version of the same collagen membrane in an otherwise identical procedure to evaluate if the compressed membrane offers the same or better bone stability.
In the restorative part, researchers will compare three types of crown finishes: non-veneered, conventionally veneered and window-veneered (test group)
Participants will be asked to come to follow-up appointments over a period of 7 years. Depending on the follow-up time in the study, different dental measurements will be taken to assess the stability of the implants and restorations.
Who can participate
Age range
18 Years – 90 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:
* Informed Consent signed by the subject
* ≥18 years of age
* No active periodontal disease
* Full-mouth plaque score and full-mouth bleeding score \<25%.
* Patients in need of an implant-supported crown at a single-tooth gap in the aesthetic region: 11-15, 21-25, 31-35, 41-45 (FDI)
* Patients in need of GBR during implant placement (1-stage procedure)
* Presence of mesial and distal natural teeth or implant
* Implant placement at least 6 weeks after tooth extraction
* No need for soft tissue grafting
Exclusion Criteria:
* Any conditions or circumstances which would interfere with the requirements for oral surgery
* Patients with large bone defects, in need of a primary bone augmentation (two-stage procedure)
* Allergy to any implant metallic component
* Allergy to collagen
* Previous oral-maxillo-facial radiotherapy
* Any disorders in the planned implant area such as previous tumors, chronic bone
* disease (such as rheumatoid disease)
* Any ongoing application of interfering medication (steroid therapy, bisphosphonate, etc.)
* Alcohol or drug abuse
* No need for soft tissue grafting
* Patients with inadequate oral hygiene or persistent oral infection
* Clinically significant concomitant diseases (e.g. renal failure, hepatic disfunction, cardiovascular diseases)
* Heavy smokers (\>10 cigarettes/day)
* Uncontrolled diabetes
* Severe bruxism or other destructive habits
* Pregnant or lactating women
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.