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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
64
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.
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.
Seven Lakes Periodontics
Fenton, Michigan, United States
RECRUITINGSocket 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.
Time frame: 4-months
Socket Soft Tissue Gap Closure - linear measures mesial-distal
Longitudinal extraction socket soft tissue gap closure measured mesial-distal from baseline to 4-months.
Time frame: 4-months
Graft Containment as observed by subject and examiner (yes/ no)
Time frame: 4-months
Inflammation Score (Loe and Sillness)
Time frame: 4-months
Biomaterial Integrity - 4-point scale
Score 0-4, 0 = biomaterial completely present, 4 = no evidence of biomaterial/ complete granulation or other tissue
Time frame: 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
Time frame: 4-months
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