Porcine Membrane vs Bovine Wound Dressing in Human Tooth Extraction Sites

Study Overview
=================
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.

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

Conditions
-----------------
Wound Heal

Intervention / Treatment
-----------------
* Device: Porcine Collagen Membrane
* Device: Bovine Collagen Dressing


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Porcine Collagen Membrane<br>Atraumatic tooth extraction with porcine collagen membrane placement | Device: Porcine Collagen Membrane<br>* Atraumatic tooth extraction with porcine collagen membrane placement<br>* Other names: Mucograft;|
| Active Comparator: Bovine Collagen Dressing<br>Atraumatic tooth extraction with bovine collagen dressing placement | Device: Bovine Collagen Dressing<br>* Atraumatic tooth extraction with bovine collagen dressing placement<br>* 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 in Hounsfield units | CBCT measurement of bone density at baseline and three months, measured in Hounsfield units | Baseline, Three Months | 
| 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 |