Two Interforaminal Implants in an Immediate or Delayed Loading Protocol for the Elderly

Study Overview
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Brief Summary
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The study population comprises 20 completely edentulous patients aged 60 years and older with severe mandible resorption. Each patient receives two inter-foraminal implants (Neoss Ltd., Harrogate, UK). Following randomization, implants are loaded either immediately after dental implant surgery or three months after implant placement with the Locator®-abutment system. At follow-up visits 3, 6 12, 24 and 36 months after loading, implant stability is evaluated with Periotest® and Ostell®.

Detailed Description
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Hypothesis: Especially for gerontoprosthetics, the Locator® abutment system offers the possibility of a minimally invasive retention of prosthetic total restorations of edentulous mandibles. The reduced number of 2 interforaminal implants is intended to ensure implantological anchoring with minimal surgical, technical, financial and time expenditure. Research Question: How safe is this minimally invasive and cost-effective implant and anchoring system in terms of long-term outcome? Are the two implant-prosthetic procedures (immediate versus late restoration) different in terms of implant survival time? Materials and methods Enrollment: 20 patients without relevant pre-existing conditions, from the age of 60 years edentulous mandible, alveolar ridge atrophy Statistical Analysis: When planning the study, it is estimated that bone resorption in the peri-implant area of the immediate-care implants is greater than in the late-treated implants. 10 patients per group are required with a t-test (α = 0.05) and a power of 80% if the null hypothesis is formulated as follows: -difference of means is 0 and the alternative - expected difference of means is 1mm, common standard deviation is 0.75. Collective A (open healing - immediate loading): Insertion of a new, prefabricated total mandibular prosthesis on the day of the operation immediately postoperatively after screwing in the Locator® abutments. Polymerization of the corresponding Locator® matrices in the newly incorporated lower jaw denture in the patient's mouth. Collective B (closed implant healing - conventional loading): 3 months after implantation Exposure of the primary closed implants. Immediately following insertion of the prefabricated full-thickness UK prosthesis and retention by the implants using Locator® abutments. Test parameters: Intraoperative torque measurement in Ncm Radiological measurement of periimplant bone height using orthopantomogram 4-point measurement of peri-implant probing depth using WHO periodontal probe. The measurement is mesial, distal, buccal and lingual of the implant. Measurement of bleeding on probing (parameters of peri-implant inflammation) using the WHO periodontal probe. Analysis of implant stability using the Periotest® and Osstell® measuring instruments according to a standardized scheme: The strength values are performed in a measuring range consisting of a straight line through the center of the implant and the resulting 180 ° circle sector anterior to this line results. After multiple measurements (5-fold) the lowest numerical value for the Periotest® and for the RFA (Osstell®) the lowest value documented.

Official Title
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Prospektive Langzeitstudie Zur Implantatprothetischen Versorgung

Conditions
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Edentulous Jaw

Intervention / Treatment
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* Procedure: Implant placement
* Procedure: immediate loading
* Procedure: conventional loading


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 60 or older edentulous lower jaw with advanced atrophy poor fit and retention even with a new prosthesis Exclusion Criteria: poor general condition (ASA classification grade IV or more), or high risk situations for implant therapy (e.g. disorders of bone metabolism due to antiresorptive therapy)

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional loading<br>Loading of 4 interforaminal implants three months after surgery. | Procedure: Implant placement<br>* interforaminal placement of 2 implants<br>Procedure: conventional loading<br>* conventional loading with a locator retained mandibular overdenture 3 months postoperatively<br>|
| Experimental: Immediate Loading<br>Loading of 4 interforaminal implants immediately after surgery. | Procedure: Implant placement<br>* interforaminal placement of 2 implants<br>Procedure: immediate loading<br>* immediate loading with a locator retained mandibular overdenture<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Implant stability | Evaluation of Implant stability with Resonance frequency analysis (Ostell®) indicating quality of osseointegration | 0,3,6,12,24,36 months | 
| Change of Implant stability | Evaluation of implant stability with electromechanical tapping (Periotest®) indicating quality of osseointegration | 0,3,6,12,24,36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dentistry, Mandibular Atrophy, Mandibular Overdenture