Tooth Extraction Clinical Trial
Official title:
A Volumetric Analysis of Soft and Hard Tissue Healing for Ridge Preservation and Socket Seal After Tooth Extraction
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.
n/a
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