Tooth ExtractionPhase 4BioGide-ComprNCT06724783
Comparison of Two Collagen Membranes for Bone Augmentation Around Dental Implants Restored with Monolithic Zirconia Single Crowns
A Phase 4 study testing Collagen membrane in people with Tooth Extraction and Tooth Replacement, run by Dr. med. dent. Malin Strasding at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Tooth Extraction, Tooth Replacement
- What is being tested?
- Collagen membrane
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteSwitzerland
- Study dates
- 30 Jun 2023to 30 Sep 2030
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- Presence of mesial and distal natural teeth or implant
- Implant placement at least 6 weeks after tooth extraction
- No need for soft tissue grafting
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
University of Geneva
Geneva, Canton of Geneva
Irena Sailer, Prof. Dr., +41 22 3794050, irena.sailer@unige.ch
About this study
Official title: A Randomized Controlled Clinical Trial to Compare Two Collagen Membranes for Guided Bone Regeneration (GBR) Around Dental Implants Restored with Monolithic Zirconia Single Crowns Using Three Different Veneering Designs
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:
Read more
- Bone stability, i.e. the difference in the bone defect depth 4 months after bone augmentation
- 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.
Read the detailed description
Guided bone regeneration (GBR) is a standard procedure to obtain the necessary bone volume for implant placement. The most frequently performed technique relies on the application of deproteinized bone particles to augment bone volume in combination with a resorbable collagen membrane to hold the particles in place and prevent gingival connective tissue invasion. To improve the elasticity and tenacity of Bio-Gide, a new collagen membrane (compressed) has been developed and placed on the market. Potentially, improved stability of bone particles due to the more firm and rigid characteristics of the new collagen membrane would aid in better space maintenance and bone regeneration around implants.
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
- Tooth Extraction, Tooth Replacement
- Being tested
- Collagen membrane
- Keywords
- guided bone regeneration (GBR), collagen membrane, dental implants, zirconia, monolithic ceramic fixed dental prosthesis (singe crowns)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collagen membraneDevice
Implant placement with simultaneous GBR covered with a collagen membrane
| Study group | Role | What they receive |
|---|---|---|
| Standard resorbable collagen membrane | Active comparator | GBR with implant placement Receives: Device: Collagen membrane |
| Compressed, stronger resorbable collagen membrane | Experimental | GBR with implant placement Receives: Device: Collagen membrane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical part: bone stability
The difference in the bone defect depth after bone augmentation (baseline) and after 4 months between the groups.
Measured: 4 months
Restorative part: chipping rates
The occurrence of ceramic chipping at the inserted single crowns
Measured: 5 years
Secondary outcomes (3)
Bone level changes
Bone width and mesial and distal bone levels
Measured: 1,3,5 years
Soft tissue volume changes
Intraoral digital scans will be analyzed with a software to assess changes in tissue volume over time.
Measured: 1,3,5 years
Restoration technical parameters
Prosthetic/functional and aesthetic parameters
Measured: 1,3,5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start30 Jun 2023
- Primary completion30 Jun 2030 (estimated)
- Study completion30 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth ExtractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. med. dent. Malin Strasding
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. med. dent. Malin Strasding, University of Geneva, Switzerland
- Investigators
- Malin Strasding, Dr dent med, Principal investigator, University Clinic of Dental Medicine, University of Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06724783
- Sponsor's protocol ID
- 2022-D0144
- Acronym
- BioGide-Compr
- Status last verified
- Dec 2024
- First submitted
- 15 May 2024
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Clinical Trial to Compare Two Collagen Membranes for Guided Bone Regeneration (GBR) Around Dental Implants Restored with Monolithic Zirconia Single Crowns Using Three Different Veneering Designs
- ClinicalTrials.gov ID
- NCT06724783
- Acronym / sponsor ID
- BioGide-Compr / 2022-D0144
- Conditions
- Tooth Extraction, Tooth Replacement
- Keywords
- guided bone regeneration (GBR), collagen membrane, dental implants, zirconia, monolithic ceramic fixed dental prosthesis (singe crowns)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Dr. med. dent. Malin StrasdingUniversity, hospital or other
- Study start
- 30 Jun 2023 (actual)
- Primary completion
- 30 Jun 2030 (estimated)
- Study completion
- 30 Sep 2030 (estimated)
- First posted
- 9 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Bone stability, i.e. the difference in the bone defect depth 4 months after bone augmentation
- 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
Guided bone regeneration (GBR) is a standard procedure to obtain the necessary bone volume for implant placement. The most frequently performed technique relies on the application of deproteinized bone particles to augment bone volume in combination with a resorbable collagen membrane to hold the particles in place and prevent gingival connective tissue invasion. To improve the elasticity and tenacity of Bio-Gide, a new collagen membrane (compressed) has been developed and placed on the market. Potentially, improved stability of bone particles due to the more firm and rigid characteristics of the new collagen membrane would aid in better space maintenance and bone regeneration around implants.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Standard resorbable collagen membrane | Active comparator | Device: Collagen membraneGBR with implant placement |
| Compressed, stronger resorbable collagen membrane | Experimental | Device: Collagen membraneGBR with implant placement |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collagen membraneImplant placement with simultaneous GBR covered with a collagen membrane | Device | Compressed, stronger resorbable collagen membrane, Standard resorbable collagen membrane |
Primary outcome
Surgical part: bone stability
Time frame: 4 months
The difference in the bone defect depth after bone augmentation (baseline) and after 4 months between the groups.
Restorative part: chipping rates
Time frame: 5 years
The occurrence of ceramic chipping at the inserted single crowns
3 secondary outcomes
Bone level changes
Time frame: 1,3,5 years
Soft tissue volume changes
Time frame: 1,3,5 years
Restoration technical parameters
Time frame: 1,3,5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Malin Strasding, Dr dent med principal investigator
University Clinic of Dental Medicine, University of Geneva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Collagen membrane in people with Tooth Extraction and Tooth Replacement, run by Dr. med. dent. Malin Strasding at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Malin Strasding, Dr dent med (+41 (0)22 379 40 50, malin.strasding@unige.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical part: bone stability (time frame: 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024.