Actively Recruiting

Phase 4
Age: 18Years - 90Years
All Genders
NCT06724783

Comparison of Two Collagen Membranes for Bone Augmentation Around Dental Implants Restored with Monolithic Zirconia Single Crowns

Led by Dr. med. dent. Malin Strasding · Updated on 2024-12-09

68

Participants Needed

1

Research Sites

378 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Comparison of Two Collagen Membranes for Bone Augmentation Around Dental Implants Restored with Monolithic Zirconia Single Crowns

Who Can Participate

Age: 18Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

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Trial Site Locations

Total: 1 location

1

University of Geneva

Geneva, Canton of Geneva, Switzerland

Actively Recruiting

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Research Team

M

Malin Strasding, Dr dent med

CONTACT

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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