This study will be a randomized clinical trial involving a total of 24 subjects. The investigators propose to recruit subjects into 2 groups: 1) Extraction treated with xenograft bone substitute (BioOss Collagen®) + collagen dressing (HeliPlug®), 2) Extraction treated with xenograft bone substitute (BioOss Collagen®) + 3D-collagen matrix (Mucograft Seal®). All subjects recruited will have already been approved and treatment planned for extraction + implant placement by non-study personnel to avoid any potential conflict of interest. All subjects will have radiographs that show the tooth planned for extraction. Each subject will be eligible for only 1 tooth extraction + dental implant rehabilitation. After tooth extraction, subjects will receive a standard site preservation therapy consisted with xenograft bone substitute + collagen dressing or the alternative site preservation therapy consisted with xenograft bone substitute + 3D-collagen matrix. After the conventional 6-month healing period, subjects will receive a dental implant in the previous extracted site. During the dental implant procedure, a 2x5mm bone core biopsy + a 2mm gingival biopsy will be obtained from the implant site. Biopsy samples will be stored for future histological and histochemical analysis. After dental implant placement, all subjects will receive a healing abutment for soft tissue healing prior to implant restoration. During the 6-month healing time after tooth extraction and site preservation therapy, subjects will return at week-1, week-2, week-4, month-3, and month-6 for intra-oral scanning for soft tissue volumetric acquirement. Subjects will receive a Cone beam computed tomography (CBCT) prior to extraction for the baseline hard-tissue volume measurement and appropriate extraction planning and at 6-month post-extraction for volumetric measurement and appropriate implant treatment planning. Hard tissue analysis will be performed to compare linear ridge remodeling (baseline vs. 6-month healing). CBCT images will be analyzed by non-contact reverse engineering system. Soft tissue volumetric analysis will be performed to compare the soft tissue healing between BioOss Collagen + Mucograft Seal and BioOss Collagen + Collagen Dressing. Images captured with an intra-oral scanner collected at baseline, week-1, -2, -4, month-3, and month-6.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Subjects requiring tooth extraction will have the hopeless tooth extracted. The extraction socket will be treated with xenograft bone substitute. At 6 months post-extraction a dental implant will be placed at the extraction site.
Subjects requiring tooth extraction will have the hopeless tooth extracted. The extraction socket treated with xenograft bone substitute will receive a collagen dressing to cover the surgical site.
Subjects requiring tooth extraction will have the hopeless tooth extracted. The extraction socket treated with xenograft bone substitute will receive a 3D collagen matrix to cover the surgical site.
General & Oral Health Center
Chapel Hill, North Carolina, United States
Change in Buccal Plate Thickness From Baseline to Month 6
The thickness difference between baseline and 6 months will be measured by the difference in mm using cone-beam computed tomography.
Time frame: 6 months
Change in Buccal Soft Tissue Volume Between Baseline and 6 Months
The soft tissue volume change between baseline and 6 months based on 3D images captured with intra-oral digital scanner.
Time frame: 6 months
Change in Buccal Bone Volume Between Baseline and 6 Months
The buccal bone volume change between baseline and 6 months will be calculated from cone-beam computed tomography data.
Time frame: 6 months
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