Esthetic Outcomes of Single Immediate Implant Placement With Immediate Restoration Performed With Two Surgical Techniques
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Gingival Recession
- Sponsor
- Columbia University
- Enrollment
- 39
- Primary Endpoint
- Change in Gingival Margin Location on the Buccal, Mesial and Distal Compared With Pre-operative Baseline and Post-operative Baseline
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
A randomized controlled trial of 12-month duration to compare gingival margin location, buccal horizontal ridge dimensions, and interproximal crestal bone levels following two surgical approaches for immediate placement of implants in the esthetic zone: one involving flap elevation and another using a flapless protocol.
Detailed Description
In the test group, the implant will be placed according to standard protocol at a position engaging the palatal wall without elevation of a mucoperiosteal flap. In the control group, intrasulcular incisions will be carried out from one tooth distal to one tooth mesial to the extraction site and full thickness flaps will be elevated with periosteal elevator, including the papillae. The implant will be placed according to standard protocol at a position engaging the palatal wall, and the flaps will be sutured using a combination of interrupted and mattress sutures. In both groups, temporary restorations will be delivered immediately after implant placement provided that the implant shows primary stability and has engaged in the bone with an insertion torque of 25Ncm or more. In case of a lower insertion torque, the protocol will be abandoned, a cover screw will be placed, and a two stage implant protocol will be followed. All patients will be advised to receive a permanent restoration 6 months after surgery, if the implant is deemed to be successful.
Investigators
Elena Sanz Miralles
Assistant Professor of Dental Medicine (Periodontics)
Columbia University
Eligibility Criteria
Inclusion Criteria
- •Single non-restorable tooth in the anterior maxilla
- •Intact buccal plate or \<5mm fenestration
Exclusion Criteria
- •Pregnancy
- •Current smokers \>10 cigarettes/day
- •Parafunctional habits
- •Malocclusion or intent of orthodontic therapy in the future
- •Severe periodontal disease
Outcomes
Primary Outcomes
Change in Gingival Margin Location on the Buccal, Mesial and Distal Compared With Pre-operative Baseline and Post-operative Baseline
Time Frame: Change from Pre-operative Baseline in Gingival Margin Location at 3, 6 and 12 months and change from post-operative baseline at 3 and 6 months
Secondary Outcomes
- Change in Buccal Horizontal Ridge Dimensions(Change from Baseline in Buccal Horizontal Ridge Dimensions at 3, 6 and 12 months)
- Change in Interproximal Crestal Bone Levels(Change from Baseline in Interproximal Crestal Bone Levels at 6 and 12 months)