Tissue PreservationSocketSealNCT03063775
Proof of Concept: Socket Seal
A study testing BioOss® + Mucograft Seal®, FGG + Bio-Oss® and FGG + Gelatine sponge (Spongostan®) in people with Tissue Preservation, run by Medical University of Graz at 1 site in Austria.
Trial summary
It is planned to evaluate if a porcine collagen matrix (Mucograft Seal) is offering comparable results to free gingival grafts (FGG) in post-extraction tissue preservation. If so, this would provide a substantial benefit to the patient as the second intervention on the palate and the subsequent morbidity of the donor… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Tissue Preservation
- What is being tested?
- BioOss® + Mucograft Seal®, FGG + Bio-Oss® and FGG + Gelatine sponge (Spongostan®)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteAustria
- Study dates
- 9 Jan 2017to 8 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Planned extraction in the upper front or premolar region
Who cannot join
- General risk situation (antiresorptive therapy, antiangiogenic therapy, history of local radiation therapy, heavy coagulation disorder, relevant allergies, dysregulated Diabetes mellitus, malignant diseases)
- Acute gingivitis
- Deep pockets (>5.5mm)
- Apical periodontitis on neighboring teeth
- Heavy smoker (>10/d)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Proof of Concept: Intra-oral Soft Tissue Preservation of Extraction Sockets in Anterior Upper Jaw
It is planned to evaluate if a porcine collagen matrix (Mucograft Seal) is offering comparable results to free gingival grafts (FGG) in post-extraction tissue preservation. If so, this would provide a substantial benefit to the patient as the second intervention on the palate and the subsequent morbidity of the donor site is omitted.
Read the detailed description
In a proof of concept 5 groups are compared in preserving soft- and hard tissue after tooth extraction in the esthetic zone:
- Mucograft® Seal + Bio-Oss®
- Free Gingival Graft (FGG) + Bio-Oss®
- Free Gingival Graft + Gelatine sponge (Spongostan®)
- Spongostan®+ Mucograft® Seal
- Spongostan®
Volumetric changes of hard and soft tissues are recorded , 2/4/8 weeks and 3/6/12 months after extraction.
- Conditions
- Tissue Preservation
- Being tested
- BioOss® + Mucograft Seal®, FGG + Bio-Oss®, FGG + Gelatine sponge (Spongostan®), Spongostan®+ Mucograft® Seal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioOss® + Mucograft Seal®Device
Placement of BioOss®-Collagen into the extraction socket. The Mucograft Seal® Membrane is then applied to the socket.
FGG + Bio-Oss®Other
Placement of BioOss®-Collagen into the extraction socket. The FGG is then attached to the socket.
FGG + Gelatine sponge (Spongostan®)Other
Placement of a Gelatine sponge into the extraction socket, then attaching the FGG to the socket.
Spongostan®+ Mucograft® SealDevice
Placement of a Gelatine sponge into the extraction socket, then attaching the Mucograft® Seal Membrane to the socket
| Study group | Role | What they receive |
|---|---|---|
| 1. Mucograft® Seal + Bio-Oss® | Active comparator | Not described Receives: Device: BioOss® + Mucograft Seal® |
| 2. FGG + Bio-Oss® | Active comparator | Not described Receives: Other: FGG + Bio-Oss® |
| 3. FGG + Gelatine sponge (Spongostan®) | Active comparator | Not described Receives: Other: FGG + Gelatine sponge (Spongostan®) |
| 4. Spongostan®+ Mucograft® Seal | Active comparator | Not described Receives: Device: Spongostan®+ Mucograft® Seal |
| 5. Spongostan® | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Soft tissue volume
Measured: 2 weeks
Soft tissue volume
Measured: 4 weeks
Soft tissue volume
Measured: 8 weeks
Secondary outcomes (3)
Bone volume
Measured: 3 months
Bone volume
Measured: 6 months
Bone volume
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2017
- Study start9 Jan 2017
- Primary completion8 Nov 2018
- Study completion8 Nov 2018
Why it stopped: Lack of suitable patients for recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tissue PreservationStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03063775
- Sponsor's protocol ID
- 7333
- Acronym
- SocketSeal
- Status last verified
- May 2019
- First submitted
- 21 Feb 2017
- Last updated
- 15 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- 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 15 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proof of Concept: Intra-oral Soft Tissue Preservation of Extraction Sockets in Anterior Upper Jaw
- ClinicalTrials.gov ID
- NCT03063775
- Acronym / sponsor ID
- SocketSeal / 7333
- Conditions
- Tissue Preservation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of suitable patients for recruitment
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 9 Jan 2017 (actual)
- Primary completion
- 8 Nov 2018 (actual)
- Study completion
- 8 Nov 2018 (actual)
- First posted
- 24 Feb 2017 (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.
It is planned to evaluate if a porcine collagen matrix (Mucograft Seal) is offering comparable results to free gingival grafts (FGG) in post-extraction tissue preservation. If so, this would provide a substantial benefit to the patient as the second intervention on the palate and the subsequent morbidity of the donor site is omitted.
Detailed description
In a proof of concept 5 groups are compared in preserving soft- and hard tissue after tooth extraction in the esthetic zone:
- Mucograft® Seal + Bio-Oss®
- Free Gingival Graft (FGG) + Bio-Oss®
- Free Gingival Graft + Gelatine sponge (Spongostan®)
- Spongostan®+ Mucograft® Seal
- Spongostan®
Volumetric changes of hard and soft tissues are recorded , 2/4/8 weeks and 3/6/12 months after extraction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1. Mucograft® Seal + Bio-Oss® | Active comparator | Device: BioOss® + Mucograft Seal® |
| 2. FGG + Bio-Oss® | Active comparator | Other: FGG + Bio-Oss® |
| 3. FGG + Gelatine sponge (Spongostan®) | Active comparator | Other: FGG + Gelatine sponge (Spongostan®) |
| 4. Spongostan®+ Mucograft® Seal | Active comparator | Device: Spongostan®+ Mucograft® Seal |
| 5. Spongostan® | No intervention | – |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Planned extraction in the upper front or premolar region
Key exclusion criteria (5 listed)
- General risk situation (antiresorptive therapy, antiangiogenic therapy, history of local radiation therapy, heavy coagulation disorder, relevant allergies, dysregulated Diabetes mellitus, malignant diseases)
- Acute gingivitis
- Deep pockets (>5.5mm)
- Apical periodontitis on neighboring teeth
- Heavy smoker (>10/d)
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 |
|---|---|---|
| BioOss® + Mucograft Seal®Placement of BioOss®-Collagen into the extraction socket. The Mucograft Seal® Membrane is then applied to the socket. | Device | 1. Mucograft® Seal + Bio-Oss® |
| FGG + Bio-Oss®Placement of BioOss®-Collagen into the extraction socket. The FGG is then attached to the socket. | Other | 2. FGG + Bio-Oss® |
| FGG + Gelatine sponge (Spongostan®)Placement of a Gelatine sponge into the extraction socket, then attaching the FGG to the socket. | Other | 3. FGG + Gelatine sponge (Spongostan®) |
| Spongostan®+ Mucograft® SealPlacement of a Gelatine sponge into the extraction socket, then attaching the Mucograft® Seal Membrane to the socket | Device | 4. Spongostan®+ Mucograft® Seal |
Primary outcome
Soft tissue volume
Time frame: 2 weeks
Soft tissue volume
Time frame: 4 weeks
Soft tissue volume
Time frame: 8 weeks
3 secondary outcomes
Bone volume
Time frame: 3 months
Bone volume
Time frame: 6 months
Bone volume
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Lack of suitable patients for recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2019.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BioOss® + Mucograft Seal®, FGG + Bio-Oss® and FGG + Gelatine sponge (Spongostan®) in people with Tissue Preservation, run by Medical University of Graz at 1 site in Austria.
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 1 inclusion and 5 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: stopped early, as of the sponsor's last update on 15 May 2019. 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 Austria. 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.
Are results available for this study?
The study was stopped early (reason given: Lack of suitable patients for recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Soft tissue volume (time frame: 2 weeks). The study lists 3 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 15 May 2019.