Immediate Loading Of Dental Implants: A Pilot Clinical Study

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2013-03-31

Brief Summary

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Objective: To provide 2-year clinical- and patient-oriented data with regard to mandibular overdenture assisted by 2 immediately loaded unsplinted implants.

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Detailed Description

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In this pre-post design, Phase-I clinical trial, 18 edentate individuals received a new set of complete denture. Then, following standard procedures, 3 threaded implants (OsseoSpeed TXTM, Dentsply Implants, Mölndal, Sweden) were placed in the mandible in each patient, and locator abutments (Zest Anchors LLC, Escondido, U.S.A.) were inserted on the right and left side implants. The midline implant served as a control for within-patient comparison. The immediate loading was conducted within 24 h of surgery. Data were collected at baseline (T0), 12 (T1) and 24 (T2) months after immediate loading. The clinical outcomes included implant survival rate, crestal bone level changes and implant stability. These criteria were assessed through clinical and radiographic examinations as well as resonance frequency analysis. Patient-centered outcomes included patient satisfaction and oral health-related quality of life measured using validated questionnaires. Brunner-Langer approach was used for statistical analysis.

Conditions

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Dental Implantation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Investigators were not involved in data analysis

Study Groups

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Immediate loading

Immediate loading of 2 endo-osseous mandibular implants

Group Type EXPERIMENTAL

Immediate loading

Intervention Type PROCEDURE

Interventions

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Immediate loading

Intervention Type PROCEDURE

Other Intervention Names

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Procedure: Immediate loading of 2 endo-osseous unsplinted implants of a mandibular overdenture

Eligibility Criteria

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Inclusion Criteria

* Minimal age of 18 years
* Complete edentulism for more than 1 year
* Wear of total conventional prosthesis for more than 1 year
* Bone morphology in the anterior mandibular region amendable for the placement of 3 regular diameter implants without any additional procedure (graft or membrane).

Exclusion Criteria

* Any absolute or relative contra-indication to implant therapy
* Physical incapacity to render oral or prosthetic hygiene
* Incapacity to obtain a free and informed consent
* Incapacity to assist to planned follow up appointments
* Incapacity to understand and complete questionnaires

* Inadequate bone quality: IT\<35 Ncm
* Inadequate primary stability: ISQ\<60

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes