Esthetic Outcomes of Single Immediate Implant Placement

Not Applicable

Completed

• Conditions: Gingival Recession; Bone Loss, Alveolar
• Interventions: Procedure: Flapless immediate implant placement; Procedure: Flap assisted immediate implant placement; Device: Implant and temporary crown

• Registration Number: NCT02435706
• Lead Sponsor: Columbia University

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.

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2015-04-15
• Study First Submitted QC: 2015-05-01
• Study First Posted: 2015-05-06
• Primary Completion: 2016-08-09
• Study Completion: 2016-08-09
• Results First Submitted: 2019-03-25
• Status Verified: 2019-04
• Results First Submitted QC: 2019-04-26
• Last Update Submitted: 2019-04-26
• Results First Posted: 2019-05-03
• Last Update Posted: 2019-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

• Single non-restorable tooth in the anterior maxilla
• Intact buccal plate or <5mm fenestration

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Exclusion Criteria

• Pregnancy
• Current smokers >10 cigarettes/day
• Parafunctional habits
• Malocclusion or intent of orthodontic therapy in the future
• Severe periodontal disease

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Flapless immediate implant placement group	Flapless immediate implant placement	Flapless placement of immediate implant and temporary crown
Flap assisted immediate implant placement group	Flap assisted immediate implant placement	Flap elevation prior to placement of immediate implant and temporary crown
Flap assisted immediate implant placement group	Implant and temporary crown	Flap elevation prior to placement of immediate implant and temporary crown
Flapless immediate implant placement group	Implant and temporary crown	Flapless placement of immediate implant and temporary crown

Primary Outcome Measures

Name	Time	Method
Change in Gingival Margin Location on the Buccal, Mesial and Distal Compared With Pre-operative Baseline and Post-operative Baseline	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 Outcome Measures

Name	Time	Method
Change in Buccal Horizontal Ridge Dimensions	Change from Baseline in Buccal Horizontal Ridge Dimensions at 3, 6 and 12 months	Horizontal changes of the buccal ridge was calculated through the use of acrylic stents and digital overlays (3Shape D800, Biomet 3i, Palm Beach Gardens, FLS). The acrylic stents were obtained from the pre-surgical plaster casts and they were repositioned on the plaster casts obtained at 3, 6 and 12 months. Discrepancies between the acrylic stent and the plaster cast were measured with a probe. The digital cast overlays were used to analyze changes from pre-surgical to 3 and from 3 to 6 months). The plaster casts were scanned and changes were analyzed with the use of a software.
Change in Interproximal Crestal Bone Levels	Change from Baseline in Interproximal Crestal Bone Levels at 6 and 12 months