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

NCT06724783 | Recruiting Phase 4

• 1 other identifier: 2022-D0144
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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. 1.Bone stability, i.e. the difference in the bone defect depth 4 months after bone augmentation
2. 2.The occurrence of ceramic restoration chipping at the inserted single crowns after 5 years.

Conditions

Tooth Extraction; Tooth Replacement

Keywords

guided bone regeneration (GBR); collagen membrane; dental implants; zirconia; monolithic ceramic fixed dental prosthesis (singe crowns)

Outcome Measures

Primary Outcomes (2)

• Surgical part: bone stability

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

  4 months

• Restorative part: chipping rates

  The occurrence of ceramic chipping at the inserted single crowns

  5 years

Secondary Outcomes (3)

• Bone level changes

  1,3,5 years

• Soft tissue volume changes

  1,3,5 years

• Restoration technical parameters

  1,3,5 years

Study Arms (2)

Standard resorbable collagen membrane

ACTIVE COMPARATOR

GBR with implant placement

Device: Collagen membrane

Compressed, stronger resorbable collagen membrane

EXPERIMENTAL

GBR with implant placement

Device: Collagen membrane

Interventions

Collagen membrane DEVICE

Implant placement with simultaneous GBR covered with a collagen membrane

Compressed, stronger resorbable collagen membrane; Standard resorbable collagen membrane

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. med. dent. Malin Strasding: lead

Study Sites (1)

University of Geneva

Geneva, Canton of Geneva, Switzerland

RECRUITING

Study Officials

• Malin Strasding, Dr dent med

  University Clinic of Dental Medicine, University of Geneva

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Malin Strasding, Dr dent med

CONTACT

+41 (0)22 379 40 50; malin.strasding@unige.ch

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior lecturer

Model Details: A two parallel arm (test and control) non-inferiority, prospective, randomized controlled, monocentric, open-label clinical trial (surgical part) A three parallel arm (test, two controls) prospective, randomized controlled, monocentric, open-label clinical trial

Study Record Dates

• First Submitted: May 15, 2024
• First Posted: December 9, 2024
• Study Start: June 30, 2023
• Primary Completion (Estimated): June 30, 2030
• Study Completion (Estimated): September 30, 2030
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)