NCT03063775

Brief 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 site is omitted.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 9, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 21, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 24, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 8, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 8, 2018

Completed
Last Updated

May 15, 2019

Status Verified

May 1, 2019

Enrollment Period

1.8 years

First QC Date

February 21, 2017

Last Update Submit

May 13, 2019

Conditions

Tissue Preservation

Outcome Measures

Primary Outcomes (3)

  • Soft tissue volume

    2 weeks

  • Soft tissue volume

    4 weeks

  • Soft tissue volume

    8 weeks

Secondary Outcomes (3)

  • Bone volume

    3 months

  • Bone volume

    6 months

  • Bone volume

    12 months

Study Arms (5)

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

Interventions

BioOss® + Mucograft Seal®DEVICE

Placement of BioOss®-Collagen into the extraction socket. The Mucograft Seal® Membrane is then applied to the socket.

1. Mucograft® Seal + Bio-Oss®
FGG + Bio-Oss®OTHER

Placement of BioOss®-Collagen into the extraction socket. The FGG is then attached to the socket.

2. FGG + Bio-Oss®
FGG + Gelatine sponge (Spongostan®)OTHER

Placement of a Gelatine sponge into the extraction socket, then attaching the FGG to the socket.

3. FGG + Gelatine sponge (Spongostan®)
Spongostan®+ Mucograft® SealDEVICE

Placement of a Gelatine sponge into the extraction socket, then attaching the Mucograft® Seal Membrane to the socket

4. Spongostan®+ Mucograft® Seal

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Planned extraction in the upper front or premolar region

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University Graz

Graz, Styria, 8010, Austria

Location

MeSH Terms

Interventions

fibrinopeptides gammaBio-OssFibrin Foam

Intervention Hierarchy (Ancestors)

FibrinBlood ProteinsProteinsAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2017

First Posted

February 24, 2017

Study Start

January 9, 2017

Primary Completion

November 8, 2018

Study Completion

November 8, 2018

Last Updated

May 15, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)