Proof of Concept: Socket Seal (SocketSeal)

May 13, 2019 updated by: Medical University of Graz

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

In a proof of concept 5 groups are compared in preserving soft- and hard tissue after tooth extraction in the esthetic zone:

  1. Mucograft® Seal + Bio-Oss®
  2. Free Gingival Graft (FGG) + Bio-Oss®
  3. Free Gingival Graft + Gelatine sponge (Spongostan®)
  4. Spongostan®+ Mucograft® Seal
  5. Spongostan®

Volumetric changes of hard and soft tissues are recorded , 2/4/8 weeks and 3/6/12 months after extraction.

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
    • Styria
      • Graz, Styria, Austria, 8010
        • Medical University Graz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

• Planned extraction in the upper front or premolar region

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1. Mucograft® Seal + Bio-Oss®
Device: BioOss® + Mucograft Seal®
Placement of BioOss®-Collagen into the extraction socket. The Mucograft Seal® Membrane is then applied to the socket.
Active Comparator: 2. FGG + Bio-Oss®
Other: FGG + Bio-Oss®
Placement of BioOss®-Collagen into the extraction socket. The FGG is then attached to the socket.
Active Comparator: 3. FGG + Gelatine sponge (Spongostan®)
Other: FGG + Gelatine sponge (Spongostan®)
Placement of a Gelatine sponge into the extraction socket, then attaching the FGG to the socket.
Active Comparator: 4. Spongostan®+ Mucograft® Seal
Device: Spongostan®+ Mucograft® Seal
Placement of a Gelatine sponge into the extraction socket, then attaching the Mucograft® Seal Membrane to the socket
No Intervention: 5. Spongostan®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Soft tissue volume
Time Frame: 2 weeks
2 weeks
Soft tissue volume
Time Frame: 4 weeks
4 weeks
Soft tissue volume
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Bone volume
Time Frame: 3 months
3 months
Bone volume
Time Frame: 6 months
6 months
Bone volume
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Graz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 9, 2017

Primary Completion (Actual)

November 8, 2018

Study Completion (Actual)

November 8, 2018

Study Registration Dates

First Submitted

February 21, 2017

First Submitted That Met QC Criteria

February 21, 2017

First Posted (Actual)

February 24, 2017

Study Record Updates

Last Update Posted (Actual)

May 15, 2019

Last Update Submitted That Met QC Criteria

May 13, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7333

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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