Actively Recruiting
A Randomized Controlled Trial Comparing Two Collagen Membranes for Bone Regeneration Around Dental Implants with Monolithic Zirconia Crowns Using Three Veneering Designs
Led by Dr. med. dent. Malin Strasding · Updated on 2024-12-09
68
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating two types of collagen membranes used in guided bone regeneration (GBR) around dental implants in patients needing a single tooth replacement in the aesthetic zone. This randomized controlled trial aims to compare bone stability four months after bone augmentation using a standard collagen membrane versus a compressed, stronger version. The study also assesses three different crown veneering methods on monolithic zirconia crowns to evaluate ceramic chipping over five years. Participants will receive an implant with simultaneous bone augmentation using bone particles covered by one of the two collagen membranes. After a healing period of four months, they will receive a crown restoration on the implant. The trial compares the standard collagen membrane with a compressed version in the surgical part and examines three veneering designs—non-veneered, conventionally veneered, and window-veneered—in the restorative part. Participants will attend follow-up visits over seven years, during which dental measurements will assess implant and restoration stability. Researchers will monitor bone level changes, soft tissue volume, and technical restoration parameters at intervals of 1, 3, and 5 years. The primary outcomes include bone stability at four months and ceramic restoration chipping rates at five years, ensuring thorough long-term observation.
CONDITIONS
Brief Title
Comparison of Two Collagen Membranes for Bone Augmentation Around Dental Implants Restored with Monolithic Zirconia Single Crowns
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent
- 18 years of age or older
- No active periodontal disease
- Full-mouth plaque and bleeding scores below 25%
- Need for an implant-supported crown at a single tooth gap in the aesthetic region (teeth 11-15, 21-25, 31-35, 41-45)
- Need for guided bone regeneration during implant placement (one-stage procedure)
- Presence of natural teeth or implants on both sides of the implant site
- Implant placement at least 6 weeks after tooth extraction
- No need for soft tissue grafting
You will not qualify if you...
- Conditions interfering with oral surgery requirements
- Large bone defects needing two-stage bone augmentation
- Allergies to implant metals or collagen
- Previous oral-maxillo-facial radiotherapy
- Disorders in the implant area such as tumors or chronic bone diseases
- Use of interfering medications like steroids or bisphosphonates
- Alcohol or drug abuse
- Inadequate oral hygiene or ongoing oral infections
- Significant health problems like kidney, liver, or heart disease
- Heavy smoking (more than 10 cigarettes per day)
- Uncontrolled diabetes
- Severe teeth grinding or other destructive habits
- Pregnant or breastfeeding women
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - One-day procedure with recovery over 4 months
Participants undergo implant placement with simultaneous guided bone regeneration (GBR) using either a standard or compressed collagen membrane.
1 surgery visit and follow-up visits over 4 months
Duration - 4 months
Participants receive post-operative care following implant placement and GBR to monitor bone stability and healing.
Multiple follow-up visits during 4 months
Duration - Up to 5 years
Participants receive monolithic zirconia single crowns with one of three veneering designs to evaluate technical outcomes such as ceramic chipping.
Regular visits for crown placement and assessments over 5 years
Trial Site Locations
Total: 1 location
1
University of Geneva
Geneva, Canton of Geneva, Switzerland
Actively Recruiting
Research Team
M
Malin Strasding, Dr dent med
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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