Dental Implant FailedNCT06554080
Survival and Success Rates of External- and Internal- Connection Dental Implants Placed Within the United Kingdom Armed Forces.
An observational study of Dental Implant Failed and Tooth Loss, run by Defence Primary Health Care, UK at 1 site in United Kingdom.
Trial summary
This is a retrospective cohort study that evaluates the survival (Outcome 1) of dental implant systems (external connection (Cohort 1) and internal connection (Cohort 2) and the effectiveness of maintaining crestal bone levels (Outcome 2), placed within United Kingdom Armed Forces personnel. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dental Implant Failed, Tooth Loss, Implant Complication
- What is being tested?
- Platform-switched implant placement and Platform-matched implant placement
- Type of treatment
- Surgery or procedure
- How many people
- 438 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 May 2024to 2 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: UK Armed Forces
Who may be able to join
- • Military patients who had dental implants placed at DCRD between the period of 01 Jan 2017 and 31 Dec 2023.
- 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.
Show all 10Show fewer
- 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).
Who cannot join
- • Implants placed outside of DPHC.
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Defence Centre of Rehabiliative Dentistry
Aldershot, Surrey, GU11 2LG
About this study
This is a retrospective cohort study that evaluates the survival (Outcome 1) of dental implant systems (external connection (Cohort 1) and internal connection (Cohort 2) and the effectiveness of maintaining crestal bone levels (Outcome 2), placed within United Kingdom Armed Forces personnel. The secondary objectives include: assessment of block bone grafting on outcome, assessment of restoration (bridge vs crown on outcome) and assessment of placement technique (immediate, early, delayed placement). Inclusion criteria: all military patients that received dental implants since 2014-2024. Exclusion criteria: military patients that have not received radiographic review or follow-up of the dental implant or who have left service or have a follow-up that is less than 12-months post placement of the dental implant..
Read the detailed description
Dental care to the United Kingdom Armed Forces (UKAF) is provided by Defence Primary Healthcare (DPHC) Dental, which incorporates a Managed Clinical Network (MCN) to co-ordinate and treat complex restorative cases referred by general dental practitioners (GDPs), with a central hub at the DCRD. The DCRD routinely employs dental implants within patients' rehabilitative treatment pathways.
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
- Dental Implant Failed, Tooth Loss, Implant Complication
- Being tested
- Platform-switched implant placement, Platform-matched implant placement
- Medical subject headings
- Tooth Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platform-switched implant placementProcedure or surgery
NobelParallel or NobelActive implants placed
Platform-matched implant placementProcedure or surgery
Nobel Brånemark, NobelSpeedy Groovy implants placed
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Platform-matched implant placement | |
| 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. Receives: Procedure: Platform-switched implant placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dental Implant Survival (presence of implant at point of review)
Null hypothesis: No difference in dental implant survival between the 2 cohorts (Platform-Matched vs Platform-Switched dental implant/ abutment interfaces). This is a binary outcome of either implant still present or implant absent at time of review.
Measured: Minimum time frame for inclusion is 12 months
Secondary outcomes (1)
Dental Implant Crestal Bone Levels
Null hypothesis: There is no difference in the crestal bone levels between the 2 cohorts (Platform-Matched vs Platform-Switched dental implant/ abutment interfaces). This outcome is measured radiographically using a software programme to determine changes in bone levels. Outcome is measured in mm.
Measured: Minimum time frame for inclusion is 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2024
- Study start2 May 2024
- Primary completion2 May 2025 (estimated)
- Study completion2 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Implant FailedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 438 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Defence Primary Health Care, UK
- Sponsor type
- Other government
- Collaborators
- University of Birmingham
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06554080
- Sponsor's protocol ID
- 2303/MODREC/24
- Status last verified
- Aug 2024
- First submitted
- 10 May 2024
- Last updated
- 14 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survival and Success Rates of External- and Internal- Connection Dental Implants Placed Within the United Kingdom Armed Forces.
- ClinicalTrials.gov ID
- NCT06554080
- Acronym / sponsor ID
- 2303/MODREC/24
- Conditions
- Dental Implant Failed, Tooth Loss, Implant Complication
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 438 participants (estimated)
- Lead sponsor
- Defence Primary Health Care, UKOther government
- Collaborators
- University of Birmingham
- Study start
- 2 May 2024 (actual)
- Primary completion
- 2 May 2025 (estimated)
- Study completion
- 2 May 2025 (estimated)
- First posted
- 14 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a retrospective cohort study that evaluates the survival (Outcome 1) of dental implant systems (external connection (Cohort 1) and internal connection (Cohort 2) and the effectiveness of maintaining crestal bone levels (Outcome 2), placed within United Kingdom Armed Forces personnel. The secondary objectives include: assessment of block bone grafting on outcome, assessment of restoration (bridge vs crown on outcome) and assessment of placement technique (immediate, early, delayed placement). Inclusion criteria: all military patients that received dental implants since 2014-2024. Exclusion criteria: military patients that have not received radiographic review or follow-up of the dental implant or who have left service or have a follow-up that is less than 12-months post placement of the dental implant..
Detailed description
Dental care to the United Kingdom Armed Forces (UKAF) is provided by Defence Primary Healthcare (DPHC) Dental, which incorporates a Managed Clinical Network (MCN) to co-ordinate and treat complex restorative cases referred by general dental practitioners (GDPs), with a central hub at the DCRD. The DCRD routinely employs dental implants within patients' rehabilitative treatment pathways.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Platform-matched | – | Procedure: Platform-matched implant placementUK 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-switched | – | Procedure: Platform-switched implant placementUK 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- UK Armed Forces
Key inclusion criteria (10 listed)
- • Military patients who had dental implants placed at DCRD between the period of 01 Jan 2017 and 31 Dec 2023.
Key exclusion criteria (7 listed)
- • Implants placed outside of DPHC.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Platform-switched implant placementNobelParallel or NobelActive implants placed | Procedure or surgery | Platform-switched |
| Platform-matched implant placementNobel Brånemark, NobelSpeedy Groovy implants placed | Procedure or surgery | Platform-matched |
Primary outcome
Dental Implant Survival (presence of implant at point of review)
Time frame: Minimum time frame for inclusion is 12 months
Null hypothesis: No difference in dental implant survival between the 2 cohorts (Platform-Matched vs Platform-Switched dental implant/ abutment interfaces). This is a binary outcome of either implant still present or implant absent at time of review.
1 secondary outcome
Dental Implant Crestal Bone Levels
Time frame: Minimum time frame for inclusion is 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Implant Failed and Tooth Loss, run by Defence Primary Health Care, UK at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dental Implant Survival (presence of implant at point of review) (time frame: Minimum time frame for inclusion is 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2024.