Porcine Membrane vs Bovine Wound Dressing in Human Tooth Extraction Sites

Wound Heal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05802602
• Other study ID #: 0145-23-FB
• Status: Recruiting
• Phase: N/A
• Start date: April 16, 2023
• Est. completion date: June 30, 2025

Study information

• Verified date: June 2024
• Source: University of Nebraska
• Contact: Amy C Killeen, DDS, MS
• Phone: 402-472-7848
• Email: akilleen[@]unmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: June 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Wound Heal
• Wounds and Injuries

Intervention

Device:
• Porcine Collagen Membrane
Atraumatic tooth extraction with porcine collagen membrane placement
• Bovine Collagen Dressing
Atraumatic tooth extraction with bovine collagen dressing placement

Locations

Country	Name	City	State
United States	University of Nebraska Medical Center, College of Dentistry	Lincoln	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
University of Nebraska

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Soft tissue thickness in mm	Soft tissue biopsy to determine tissue thickness, measured in mm	6 weeks
Secondary	Bone density in Hounsfield units	CBCT measurement of bone density at baseline and three months, measured in Hounsfield units	Baseline, Three Months
Secondary	Interleukiin - 1beta, measured in pg/mL	Interleukin 1beta will be assessed at baseline and 6 weeks via GCF sampling, measured in pg/mL	Baseline, 6 weeks