Porcine Membrane vs Bovine Wound Dressing in Human Tooth Extraction Sites

NCT ID: NCT05802602

Last Updated: 2025-12-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-16
• Study Completion Date: 2025-11-30

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.

Conditions

Wound Heal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Porcine Collagen Membrane

Atraumatic tooth extraction with porcine collagen membrane placement

Group Type: EXPERIMENTAL

Porcine Collagen Membrane

Intervention Type: DEVICE

Atraumatic tooth extraction with porcine collagen membrane placement

Bovine Collagen Dressing

Atraumatic tooth extraction with bovine collagen dressing placement

Group Type: ACTIVE_COMPARATOR

Bovine Collagen Dressing

Intervention Type: DEVICE

Atraumatic tooth extraction with bovine collagen dressing placement

Interventions

Porcine Collagen Membrane

Atraumatic tooth extraction with porcine collagen membrane placement

Intervention Type: DEVICE

Bovine Collagen Dressing

Atraumatic tooth extraction with bovine collagen dressing placement

Intervention Type: DEVICE

Other Intervention Names

Mucograft; Heliplug

Eligibility Criteria

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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Nebraska

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amy C Killeen, DDS, MS

Role: PRINCIPAL_INVESTIGATOR

University of Nebraska

Locations

University of Nebraska Medical Center, College of Dentistry

Lincoln, Nebraska, United States

Countries

United States

Other Identifiers

0145-23-FB

Identifier Type: -

Identifier Source: org_study_id