NCT03003819

A Comparison of Two Socket Sealing Collagen Matrices for Extraction Socket Management

A Prospective, Randomized, Controlled, Multi-center Evaluation of Extraction Socket Management Comparing Two Socket Sealing Collagen Matrices

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: McGuire Institute · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A prospective RCT of intact extractions with delayed implant placement comparing extraction socket management effectiveness and office economics of two collagen matrices. Soft tissue wound healing will be assessed out to 4-months post-operative, when implants will be placed.

Detailed description

A prospective, randomized, multi-center, controlled clinical study of intact extractions (bony dehiscences \<1/3 socket apico-coronal and mesial-distal dimension) with delayed implant placement. Study objective: to compare extraction socket management effectiveness and office economics of a frequently used wound dressing (control) with a soft tissue augmentation matrix (test) in 32-64 subjects 18 -75 years of age with intact (bony dehiscence, if present, \< 1/3 socket dimension) extractions intended for dental implant replacement. Following screening subjects will undergo tooth extraction and randomization to either the control or test therapy. After treatment, subjects will be followed until 4- months, the time of implant placement. Primary outcome: soft tissue wound healing measured by (1) gap closure and (2) graft containment at all time points.

Conditions

• Tooth Loss

Interventions

Type	Name	Description
DEVICE	Control Collagen Wound Dressing	Following resolution of any periodontal issues in the region of study and administration of pre-surgical antibiotic and local anesthetic, minimally traumatic extraction will be performed with periotomes . After degranulation and bone graft placement, control or test biomaterial will be placed according to the randomization schedule and surgical instructions for each biomaterial.
DEVICE	Test Collagen Matrix	Following resolution of any periodontal issues in the region of study and administration of pre-surgical antibiotic and local anesthetic, minimally traumatic extraction will be performed with periotomes . After degranulation and bone graft placement, control or test biomaterial will be placed according to the randomization schedule and surgical instructions for each biomaterial.

Timeline

• Start date: 2016-10-01
• Primary completion: 2020-04-01
• Completion: 2020-06-01
• First posted: 2016-12-28
• Last updated: 2020-02-20

Locations

1 site across 1 country: United States