Esthetic Outcomes of Single Immediate Implant Placement

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2016-08-09

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Gingival Recession Bone Loss, Alveolar

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Flapless immediate implant placement group

Flapless placement of immediate implant and temporary crown

Group Type EXPERIMENTAL

Flapless immediate implant placement

Intervention Type PROCEDURE

Experimental group: No elevation of flap prior to immediate implant placement

Implant and temporary crown

Intervention Type DEVICE

Both groups receive this intervention

Flap assisted immediate implant placement group

Flap elevation prior to placement of immediate implant and temporary crown

Group Type ACTIVE_COMPARATOR

Flap assisted immediate implant placement

Intervention Type PROCEDURE

Control group: Flap will be elevated prior to immediate implant placement

Implant and temporary crown

Intervention Type DEVICE

Both groups receive this intervention

Interventions

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Flapless immediate implant placement

Experimental group: No elevation of flap prior to immediate implant placement

Intervention Type PROCEDURE

Flap assisted immediate implant placement

Control group: Flap will be elevated prior to immediate implant placement

Intervention Type PROCEDURE

Implant and temporary crown

Both groups receive this intervention

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes