Porcine Membrane vs Bovine Wound Dressing in Human Tooth Extraction Sites

Comparison of Porcine Collagen Membrane and Bovine Collagen Wound Dressing in Human Extraction Sites With DFDBA Graft: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Wound Heal
• Intervention / Treatment: Device: Porcine Collagen Membrane; Device: Bovine Collagen Dressing

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.

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Lincoln, Nebraska, United States, 68503
      • University of Nebraska Medical Center, College of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Non-smoking
• Aged 19-65
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Porcine Collagen Membrane; Atraumatic tooth extraction with porcine collagen membrane placement	Device: Porcine Collagen Membrane; Atraumatic tooth extraction with porcine collagen membrane placement; Other Names: Mucograft
Active Comparator: Bovine Collagen Dressing; Atraumatic tooth extraction with bovine collagen dressing placement	Device: Bovine Collagen Dressing; Atraumatic tooth extraction with bovine collagen dressing placement; Other Names: Heliplug

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Soft Tissue Thickness in mm	Soft tissue biopsy to determine tissue thickness, measured in mm	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bone Density Measurements	Bone density measurements to assess vital bone, bone tissue that retains living cells and a blood supply, at the extraction site CBCT measurement of bone density at baseline and three months, measured in Hounsfield units	Baseline, 3 Months
Interleukin-1beta	Interleukin-1beta (IL-1β), a pro-inflammatory cytokine primarily produced by immune cells and measured in pg/mL, will be assessed from gingival crevicular fluid (GCF) samples around the extraction site taken at baseline, 2 weeks and 6 weeks.	Baseline, 2 Weeks & 6 Weeks

Collaborators and Investigators

• Sponsor: University of Nebraska
• Investigators: Principal Investigator: Amy C Killeen, DDS, MS, University of Nebraska

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2023
• Primary Completion (Actual): November 30, 2025
• Study Completion (Actual): November 30, 2025

Study Registration Dates

• First Submitted: March 2, 2023
• First Submitted That Met QC Criteria: April 5, 2023
• First Posted (Actual): April 6, 2023

Study Record Updates

• Last Update Posted (Actual): February 11, 2026
• Last Update Submitted That Met QC Criteria: February 6, 2026
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: 0145-23-FB

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: Yes