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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Collagen Wound Dressing | Active Comparator | Bovine collagen sponge used to control bleeding, stabilize blood clots and protect dental wounds |
|
| Test Collagen Matrix | Active Comparator | Bilayer, porcine collagen matrix for soft tissue regeneration used as a socket seal in extraction socket grafting |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control Collagen Wound Dressing | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Socket Soft Tissue Gap Closure - linear measures buccal-lingual in millimeters | Longitudinal extraction socket soft tissue gap closure measured buccal-lingual from baseline to 4-months. | 4-months |
| Measure | Description | Time Frame |
|---|---|---|
| Socket Soft Tissue Gap Closure - linear measures mesial-distal | Longitudinal extraction socket soft tissue gap closure measured mesial-distal from baseline to 4-months. | 4-months |
| Graft Containment as observed by subject and examiner (yes/ no) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Diego Velasquez, DDS, MSD | Contact | 810.750.3500 | Periomichigan@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Todd V Scantlebury, BS | The McGuire Institute | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seven Lakes Periodontics | Recruiting | Fenton | Michigan | 48430 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22145767 | Background | Thoma DS, Sancho-Puchades M, Ettlin DA, Hammerle CH, Jung RE. Impact of a collagen matrix on early healing, aesthetics and patient morbidity in oral mucosal wounds - a randomized study in humans. J Clin Periodontol. 2012 Feb;39(2):157-65. doi: 10.1111/j.1600-051X.2011.01823.x. Epub 2011 Dec 6. | |
| 15332186 | Background |
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| ID | Term |
|---|---|
| D016388 | Tooth Loss |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D014076 | Tooth Diseases |
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|
| Test Collagen Matrix | Device | 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. |
|
| 4-months |
| Inflammation Score (Loe and Sillness) | 4-months |
| Biomaterial Integrity - 4-point scale | Score 0-4, 0 = biomaterial completely present, 4 = no evidence of biomaterial/ complete granulation or other tissue | 4-months |
| Tissue Thickness - probe show-thru at baseline and biopsy measure in millimeters at 4-months | Soft tissue thickness is measured using probe "show-thru" (tissue transparency) at baseline and soft tissue biopsy at the implant site immediately prior to implant placement | 4-months |
| Sclar AG. Strategies for management of single-tooth extraction sites in aesthetic implant therapy. J Oral Maxillofac Surg. 2004 Sep;62(9 Suppl 2):90-105. doi: 10.1016/j.joms.2004.06.041. |