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Porcine Membrane vs Bovine Wound Dressing in Human Tooth Extraction Sites

Primary Purpose

Wound Heal

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Porcine Collagen Membrane
Bovine Collagen Dressing
Sponsored by
University of Nebraska
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wound Heal

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: nonsmoking adults aged 18-65 requiring premolar or anterior tooth extraction and graft procedures good general health willing to provide informed consent. Exclusion Criteria: history of radiation therapy or bisphosphonate use, pregnancy or breastfeeding, systemic conditions that affect bone healing contraindications to dental implants inability to attend follow-up visits.

Sites / Locations

  • University of Nebraska Medical Center, College of DentistryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Porcine Collagen Membrane

Bovine Collagen Dressing

Arm Description

Atraumatic tooth extraction with porcine collagen membrane placement

Atraumatic tooth extraction with bovine collagen dressing placement

Outcomes

Primary Outcome Measures

Soft tissue thickness in mm
Soft tissue biopsy to determine tissue thickness, measured in mm

Secondary Outcome Measures

Bone density in Hounsfield units
CBCT measurement of bone density at baseline and three months, measured in Hounsfield units
Interleukiin - 1beta, measured in pg/mL
Interleukin 1beta will be assessed at baseline and 6 weeks via GCF sampling, measured in pg/mL

Full Information

First Posted
March 2, 2023
Last Updated
September 29, 2023
Sponsor
University of Nebraska
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1. Study Identification

Unique Protocol Identification Number
NCT05802602
Brief Title
Porcine Membrane vs Bovine Wound Dressing in Human Tooth Extraction Sites
Official Title
Comparison of Porcine Collagen Membrane and Bovine Collagen Wound Dressing in Human Extraction Sites With DFDBA Graft: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 16, 2023 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nebraska

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to compare porcine collagen membrane and bovine collagen wound dressing in human tooth extraction sites. The outcomes measured will be soft tissue thickness changes as well as bone density changes.
Detailed Description
The purpose of this study is to compare the effectiveness of a porcine collagen membrane to a bovine collagen wound dressing for atraumatic extractions. These are both commonly used as a barrier and containment material over atraumatic extraction sites that are grafted for future implant placement. The study will include nonsmoking adults aged 18-65 requiring premolar or anterior tooth extraction and graft procedures, who are in good general health and willing to provide informed consent. Exclusion criteria include a history of radiation therapy or bisphosphonate use, pregnancy or breastfeeding, systemic conditions that affect bone healing, contraindications to dental implants, and inability to attend follow-up visits. The study will be a double-blind randomized controlled trial involving 24 patients who will be assigned to two groups. Prior to tooth extraction, baseline data will be collected; including gingival crevicular fluid (GCF) sampling, and a limited field Cone Beam Computed Tomography (CBCT) radiograph. A reference digital scan will be taken to measure volumetric changes in soft tissue. Routine, atraumatic extraction of the tooth under local anesthetic will be performed. Following extraction, hydrated AllOss 50/50 DFDBA:FDBA (demineralized freeze-dried bone allograft:freeze-dried bone allograft) bone particulate will be condensed following a routine protocol. One group will receive Mucograft Seal over the graft, and the other group will receive Integra HeliPlug. Patients will be seen at a standard 2-week follow up to remove sutures, have a GCF sampling at the adjacent teeth and take another digital scan. Patients will be seen for an additional 6-week follow up to take a small (2mm) incisional biopsy for histological analysis. Another digital scan and GCF sampling will be taken. Final evaluation will be 3 months post-extraction and will include a localized CBCT evaluation for implant planning and another measure of soft tissue changes with a digital scan. At the time of implant surgery, the core of bone removed during osteotomy will be histologically analyzed for percentage of vital bone. Adverse events will also be recorded at each visit. The primary outcome measure will be the histological composition of tissue at 6 weeks and volumetric tissue changes. The secondary outcome measures will be bone density changes on the post-operative CBCT and inflammatory bio-markers present at baseline, 2-weeks via GCF sampling.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound Heal

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Porcine Collagen Membrane
Arm Type
Experimental
Arm Description
Atraumatic tooth extraction with porcine collagen membrane placement
Arm Title
Bovine Collagen Dressing
Arm Type
Active Comparator
Arm Description
Atraumatic tooth extraction with bovine collagen dressing placement
Intervention Type
Device
Intervention Name(s)
Porcine Collagen Membrane
Other Intervention Name(s)
Mucograft
Intervention Description
Atraumatic tooth extraction with porcine collagen membrane placement
Intervention Type
Device
Intervention Name(s)
Bovine Collagen Dressing
Other Intervention Name(s)
Heliplug
Intervention Description
Atraumatic tooth extraction with bovine collagen dressing placement
Primary Outcome Measure Information:
Title
Soft tissue thickness in mm
Description
Soft tissue biopsy to determine tissue thickness, measured in mm
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Bone density in Hounsfield units
Description
CBCT measurement of bone density at baseline and three months, measured in Hounsfield units
Time Frame
Baseline, Three Months
Title
Interleukiin - 1beta, measured in pg/mL
Description
Interleukin 1beta will be assessed at baseline and 6 weeks via GCF sampling, measured in pg/mL
Time Frame
Baseline, 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: nonsmoking adults aged 18-65 requiring premolar or anterior tooth extraction and graft procedures good general health willing to provide informed consent. Exclusion Criteria: history of radiation therapy or bisphosphonate use, pregnancy or breastfeeding, systemic conditions that affect bone healing contraindications to dental implants inability to attend follow-up visits.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amy C Killeen, DDS, MS
Phone
402-472-7848
Email
akilleen@unmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy C Killeen, DDS, MS
Organizational Affiliation
University of Nebraska
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Nebraska Medical Center, College of Dentistry
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68503
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amy C Killeen, DDS, MS
Phone
402-472-7848
Email
akilleen@unmc.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Porcine Membrane vs Bovine Wound Dressing in Human Tooth Extraction Sites

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