NCT06724783 Comparison of Two Collagen Membranes for Bone Augmentation Around Dental Implants Restored with Monolithic Zirconia Single Crowns
| NCT ID | NCT06724783 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Dr. med. dent. Malin Strasding |
| Condition | Tooth Extraction |
| Study Type | INTERVENTIONAL |
| Enrollment | 68 participants |
| Start Date | 2023-06-30 |
| Primary Completion | 2030-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 68 participants in total. It began in 2023-06-30 with a primary completion date of 2030-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Malin Strasding, Dr dent med
PRINCIPAL INVESTIGATOR
University Clinic of Dental Medicine, University of Geneva
Frequently Asked Questions
Who can join the NCT06724783 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Tooth Extraction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06724783 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06724783 currently recruiting?
Yes, NCT06724783 is actively recruiting participants. Contact the research team at malin.strasding@unige.ch for enrollment information.
Where is the NCT06724783 trial being conducted?
This trial is being conducted at Geneva, Switzerland.
Who is sponsoring the NCT06724783 clinical trial?
NCT06724783 is sponsored by Dr. med. dent. Malin Strasding. The principal investigator is Malin Strasding, Dr dent med at University Clinic of Dental Medicine, University of Geneva. The trial plans to enroll 68 participants.