Survival and Success Rates of External- and Internal- Connection Dental Implants Placed Within the United Kingdom Armed Forces.

NCT06554080 | Active Not Recruiting

• 1 other identifier: 2303/MODREC/24
• Study Type: observational
• Target: 438
• Locations: 1 country
• Sites: 1

Brief 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. 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..

Conditions

Dental Implant Failed; Tooth Loss; Implant Complication

Outcome Measures

Primary Outcomes (1)

• 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.

  Minimum time frame for inclusion is 12 months

Secondary Outcomes (1)

• Dental Implant Crestal Bone Levels

  Minimum time frame for inclusion is 12 months

Study Arms (2)

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.

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.

Procedure: Platform-switched implant placement

Interventions

Platform-switched implant placement PROCEDURE

NobelParallel or NobelActive implants placed

Platform-switched

Platform-matched implant placement PROCEDURE

Nobel Brånemark, NobelSpeedy Groovy implants placed

Platform-matched

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

UK Armed Forces

You may qualify if:

• 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.
• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Defence Primary Health Care, UK: lead
• University of Birmingham: collaborator

Study Sites (1)

Defence Centre of Rehabiliative Dentistry

Aldershot, Surrey, GU11 2LG, United Kingdom

Location

MeSH Terms

Conditions

Tooth Loss

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Tooth Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2024
• First Posted: August 14, 2024
• Study Start: May 2, 2024
• Primary Completion: May 2, 2025
• Study Completion: May 2, 2025
• Last Updated: August 14, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)