Esthetic Outcomes of Single Immediate Implant Placement

Columbia University

Status: Completed

Conditions: Bone Loss, Alveolar; Gingival Recession

Treatments: Device: Implant and temporary crown; Procedure: Flap assisted immediate implant placement; Procedure: Flapless immediate implant placement

Study type: Interventional

Funder types: Other

Identifiers

NCT02435706

AAAI1840

Details and patient eligibility

About

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.

Full 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.

Enrollment: 39 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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39 participants in 2 patient groups

Flapless immediate implant placement group

Experimental group

Description:

Flapless placement of immediate implant and temporary crown

Treatment:

Procedure: Flapless immediate implant placement

Device: Implant and temporary crown

Flap assisted immediate implant placement group

Active Comparator group

Description:

Flap elevation prior to placement of immediate implant and temporary crown

Treatment:

Device: Implant and temporary crown

Procedure: Flap assisted immediate implant placement