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

Prospektive Langzeitstudie Zur Implantatprothetischen Versorgung

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04292132
Enrollment
19
Registered
2020-03-02
Start date
2012-07-02
Completion date
2018-12-30
Last updated
2020-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Edentulous Jaw

Keywords

Dentistry, Mandibular Atrophy, Mandibular Overdenture

Brief summary

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

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: 1. Intraoperative torque measurement in Ncm 2. Radiological measurement of periimplant bone height using orthopantomogram 3. 4-point measurement of peri-implant probing depth using WHO periodontal probe. The measurement is mesial, distal, buccal and lingual of the implant. 4. Measurement of bleeding on probing (parameters of peri-implant inflammation) using the WHO periodontal probe. 5. 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.

Interventions

PROCEDUREImplant placement

interforaminal placement of 2 implants

immediate loading with a locator retained mandibular overdenture

conventional loading with a locator retained mandibular overdenture 3 months postoperatively

Sponsors

Neoss Ltd., Harrogate, UK
CollaboratorUNKNOWN
Medical University of Graz
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Change of Implant stability0,3,6,12,24,36 monthsEvaluation of Implant stability with Resonance frequency analysis (Ostell®) indicating quality of osseointegration

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026