Survival and Success Rates of External- and Internal- Connection Dental Implants Placed Within the United Kingdom Armed Forces.
NCT ID: NCT06554080
Last Updated: 2024-08-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
438 participants
OBSERVATIONAL
2024-05-02
2025-05-02
Brief Summary
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Detailed Description
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Nobel Biocare are the sole provider of dental implants to DPHC with three-systems (Nobel Speedy Groovy, Nobel Active and Nobel Parallel) routinely employed. Of the three systems, Nobel Speedy Groovy have been in use for over 20-years, employing an external hexagon prosthet-ic connection (EH). With EH, the microbiological junction lies at the vertical junction of the abutment and implant (Platform-Matched (P-M)). Subsequently, a 1mm zone of inflammation occurs around this junction with associated crestal bone loss. The establishment of crestal bone levels at the first thread of the implant was within the parameters of implant success. In contrast, Nobel Active and Parallel systems employ an internal conical connection (CC) that facilitates a platform-switching (P-S) approach to restoration of the implant. The platform switching concept aims to move the microbiological junction to the horizontal coronal surface of the implant, away from the implant/ alveolar junction, with the aim of preserving vertical crestal bone to the full height of the implant. This study aims to evaluate whether platform-switching influences dental implant survival (primary outcome) and radiographic bone levels (secondary outcome).
The study aims to account for the following factors on the outcome measures: dental implant pathway protocol (immediately-, early-, delayed- or late-placement protocols post extraction), bone grafting (to facilitate implant provision) either undertaken either prior to- or during- implant placement (block grafting, sinus floor elevation, augmentation at time of placement) and restoration type (crown, bridge, over-denture support).
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Platform-matched
UK Armed Forces patients who had platform-switched implants (Nobel Brånemark or NobelSpeedy Groovy) placed at DCRD between the period of 01 Jan 2017 and 31 Dec 2023.
Platform-matched implant placement
Nobel Brånemark, NobelSpeedy Groovy implants placed
Platform-switched
UK Armed Forces patients who had platform-switched implants (NobelParallel or NobelActive) placed at DCRD between the period of 01 Jan 2017 and 31 Dec 2023.
Platform-switched implant placement
NobelParallel or NobelActive implants placed
Interventions
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Platform-switched implant placement
NobelParallel or NobelActive implants placed
Platform-matched implant placement
Nobel Brånemark, NobelSpeedy Groovy implants placed
Eligibility Criteria
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Inclusion Criteria
* Patients over the age of 18 (female) and 19 (male, to allow for recommended lower age limits for implant placement due to facial growth).
* Healthy and medically compromised patients (diabetes mellitus type-2 (DM2), systemic steroid usage, immune-supressed patients, smoking habits).
* Implants placed with concomitant grafting or in a site where socket-preservation procedure completed.
* Patients with periodontal health as well as history of periodontal disease.
* Dental Implant types to include Nobel Biocare; Parallel, Active, Branemark and SpeedyGroovy.
* Implants with immediate, early, delayed and late implant placement pathways.
* Implants restored with single unit and multi-unit fixed prostheses.
* Minimum of 12-month follow-up data available.
* Pre-operative long cone periapical (LCPA) radiographs available to view at surgical placement, implant restoration and follow-up (12-month).
Exclusion Criteria
* Implants placed in sites where a block-grafts or sinus floor elevation procedure completed.
* Implants supporting removable prostheses.
* Implants placed prior to- or after- closure of trial period.
* Patients under the age of 18 (female) and 19 (male).
* No follow-up LCPA.
* Patients that died before pathway/ follow-up was completed.
18 Years
ALL
No
Sponsors
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University of Birmingham
OTHER
Defence Primary Health Care, UK
OTHER_GOV
Responsible Party
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Locations
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Defence Centre of Rehabiliative Dentistry
Aldershot, Surrey, United Kingdom
Countries
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Other Identifiers
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2303/MODREC/24
Identifier Type: -
Identifier Source: org_study_id
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