Comparison of Two Collagen Membranes for Bone Augmentation Around Dental Implants Restored with Monolithic Zirconia Single Crowns
NCT ID: NCT06724783
Last Updated: 2024-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
68 participants
INTERVENTIONAL
2023-06-30
2030-09-30
Brief Summary
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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.
Detailed Description
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Prosthetic restorations must be placed on implants to allow normal denture function. One of the major technical complications occurring in metal-ceramic and all-ceramic single and multiple implant-borne fixed dental prostheses (FDPs) is ceramic chipping. In highly aesthetic regions facial veneering is often necessary to overcome the aesthetic limitations of monolithic ceramic ingots. The development of a novel yet standardized approach when designing a "micro-veneered" restoration, namely window veneering, in the dental laboratory may be helpful for the reduction of chipping rates.
The primary objective of the surgery part is to determine whether the application of the new collagen membrane in a one-stage GBR+implant placement procedure results in a similar change of bone level height after 4 months compared to the application of the standard collagen membrane.
The primary objective of the restorative part is to examine the technical outcomes of the ceramic (chipping/ fracture) of three veneering designs of monolithic zirconia crowns (buccal window veneer leaving the incisal edge, standardized buccal micro-veneering or no-veneering, during 5 years of clinical function.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard resorbable collagen membrane
GBR with implant placement
Collagen membrane
Implant placement with simultaneous GBR covered with a collagen membrane
Compressed, stronger resorbable collagen membrane
GBR with implant placement
Collagen membrane
Implant placement with simultaneous GBR covered with a collagen membrane
Interventions
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Collagen membrane
Implant placement with simultaneous GBR covered with a collagen membrane
Eligibility Criteria
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Inclusion Criteria
* ≥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
* 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
18 Years
90 Years
ALL
No
Sponsors
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Dr. med. dent. Malin Strasding
OTHER
Responsible Party
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Dr. med. dent. Malin Strasding
Senior lecturer
Principal Investigators
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Malin Strasding, Dr dent med
Role: PRINCIPAL_INVESTIGATOR
University Clinic of Dental Medicine, University of Geneva
Locations
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University of Geneva
Geneva, Canton of Geneva, Switzerland
Countries
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Central Contacts
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Facility Contacts
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Irena Sailer, Prof. Dr.
Role: primary
Other Identifiers
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2022-D0144
Identifier Type: -
Identifier Source: org_study_id