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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-90
SponsorDr. med. dent. Malin Strasding

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Informed Consent signed by the subject

≥18 years of age

No active periodontal disease

Full-mouth plaque score and full-mouth bleeding score <25%.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Collagen membrane

    Device

    Implant placement with simultaneous GBR covered with a collagen membrane

Treatment groups

68 Participants
are divided into 2 treatment groups
Group A: Standard resorbable collagen membraneActive comparator 1 intervention
Group B: Compressed, stronger resorbable collagen membraneExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Surgical part: bone stability

The difference in the bone defect depth after bone augmentation (baseline) and after 4 months between the groups.

Time frame
4 months
2

Restorative part: chipping rates

The occurrence of ceramic chipping at the inserted single crowns

Time frame
5 years

Secondary outcomes

1

Bone level changes

Bone width and mesial and distal bone levels

Time frame
1,3,5 years
2

Soft tissue volume changes

Intraoral digital scans will be analyzed with a software to assess changes in tissue volume over time.

Time frame
1,3,5 years
3

Restoration technical parameters

Prosthetic/functional and aesthetic parameters

Time frame
1,3,5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dr. med. dent. Malin Strasding

Lead sponsor

University of Geneva, Switzerland

Sponsor institution