Clinical Study Comparing Submerged Versus Trans-mucosal Healing of P.004 Implants in the Anterior Mandible and Maxilla

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

145 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2013-10-31

Brief Summary

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The purpose of this study is To demonstrate that there is no difference in change in bone level around P.004 implants between 1st stage surgery and 6 months post surgery when transmucosal implant placement is compared to submerged implant placement

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Detailed Description

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The primary objective of this study is to determine the level at which the bone can be maintained in relation to the implant shoulder for the P.004 two-stage implant when placed in a submerged or a trans-mucosal procedure in single tooth gaps in the anterior region. The primary parameter will be measured by radiography 26 weeks after loading of the implant.

Conditions

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Jaw, Edentulous, Partially

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Submerged healing

The Straumann Bone Level Implant(s) will be placed using a submerged healing treatment

Group Type ACTIVE_COMPARATOR

Straumann Bone Level Implant

Intervention Type DEVICE

Straumann Bone Level Implant, SLActive surface, diameter 4.1, length 8, 10, 12, and 14 mm

Trans-mucosal healing

The Straumann Bone Level Implant(s) will be placed using a trans-mucosal healing treatment

Group Type ACTIVE_COMPARATOR

Straumann Bone Level Implant

Intervention Type DEVICE

Straumann Bone Level Implant, SLActive surface, diameter 4.1, length 8, 10, 12, and 14 mm

Interventions

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Straumann Bone Level Implant

Straumann Bone Level Implant, SLActive surface, diameter 4.1, length 8, 10, 12, and 14 mm

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Males and females \>18 years of age.
* Implant placement planned in the anterior maxilla or mandible (FDI tooth numbers 21 - 25, 11 - 15, 31-35, 41-45).
* Tooth site must have a natural tooth both mesially and distally in the adjacent tooth positions
* Opposing dentition of natural teeth, or tooth or implant-supported fixed restorations.
* Adequate bone quality and quantity at the implant site to permit the insertion of a Straumann P.004 SLActive implant of 8, 10, 12, or 14 mm length.
* Presence of a sufficient band of keratinized mucosa (min. 2 mm) to allow surgical manipulation and suturing according to the protocol
* Signed informed consent document before being treated in the study

Exclusion Criteria

* Systemic disease that would interfere with dental implant therapy (e.g. uncontrolled diabetes)
* Any contraindications for oral surgical procedures
* Current untreated periodontitis or gingivitis
* Probing pocket depth of more than 4 mm at one of the adjacent teeth
* Mucosal diseases (e.g. erosive lichen planus)
* History of local irradiation therapy
* Bone augmentation procedures if the procedure require healing time of more than 12 weeks after implant placement
* Implants in adjacent position to planned implant
* Severe bruxing or clenching habits
* Heavy smokers: Patients who smoke more than 20 cigarettes per day
* Conditions or circumstances, in the opinion of the investigator, which would prevent completion of study participation.
* Patients with inadequate oral hygiene or unmotivated for adequate home care

* Lack of primary stability of the implant
* Inappropriate implant position to insert implants according to the prosthetic requirements.
* Patients with augmentation procedures requiring more than 12 weeks healing time.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No