Jaw, Edentulous, Partially Clinical Trial
Official title:
Esthetic, Clinical and Radiographic Outcomes of Immediately Placed Implants (Type 1) and Early Placed Implants (Type 2)
The investigators are asking subjects to take part in a research study of soft tissue (gums)
and bone (jawbone) healing around dental implants following tooth extraction. The
investigators want to compare how the gums and the bone changes shape with healing in two
different scenarios:
1. When the implant is placed at the same time the tooth is extracted.
2. When the tooth is extracted and then left to heal for a period of 4 to 8 weeks before
the implant is placed.
Previous studies have shown that both methods work and can give good results. In fact the two
methods are used routinely as part of standard care but it is not known if the two procedures
are equally good since they have never been compared in one same research study.
This controlled, randomized clinical trial (RCT) is designed to compare soft and hard tissue
dimensional changes for two commonly used approaches for replacing a recently extracted tooth
by means of a dental implant, i.e. immediate implant placement (Type 1) or early implant
placement (Type 2). Additionally, this study will evaluate the association between the
osseous anatomy and implant position with soft and hard tissue changes.
Extraction sites will include maxillary and mandibular anterior and premolar teeth having
intact adjacent teeth. Implants placed for this study will be SLA surface, bone level design,
Straumann BL RC (Bone Level Regular Cross-fit ) 4.1mm or BL NC (Bone Level Narrow Cross-fit )
3.3mm diameter implants at 8, 10, 12 or 14mm in length.
Immediate implant placement (Type 1) resulting in a horizontal defect dimension (HDD) will
receive bone grafting, using freeze dried bone allograft (FDBA)(Straumann Allograft GC®) and
will be covered by a resorbable membrane (BioGide®).
For the implants randomized to type 2 implant placement, the extraction socket will be filled
with a collagen plug and allowed to heal for 4 to 8 weeks before the implant will be placed.
Simultaneous guided bone regeneration (GBR) will be performed using FDBA (Straumann Allograft
GC®)and a resorbable collagen membrane (BioGide®). The type 2 implant placement procedure
will follow the guidelines as described by Buser et al. (2008).
All implant placement will follow standard protocols utilizing tapping and placement
according to the manufacturer's guidelines.
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