Osseointegration Failure of Dental ImplantNCT04061694
Immediate Loading and Fully Guided Surgery: Single Implants
A study testing Immediate loading, fully guided surgery and 3D printed restoration and Immediate loading in people with Osseointegration Failure of Dental Implant, run by Folktandvården Skåne AB at 1 site in Sweden.
Trial summary
To evaluate the overall treatment outcome of single implants installed with the assistance of fully guided-surgery, submitted to immediate loading with restorations fabricated with the help of intraoral scanning, during a 1-year follow-up period. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osseointegration Failure of Dental Implant
- What is being tested?
- Immediate loading, fully guided surgery and 3D printed restoration and Immediate loading
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteSweden
- Study dates
- Nov 2016to Aug 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- at least 18 years of age who had signed an informed consent
- in need of a single-tooth replacement of an incisor, canine or pre-molar in the maxilla.
Who cannot join
- general contraindications for oral surgery
- patients with inadequate oral hygiene
- need for bone grafting or ridge augmentation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immediate Loading of Single Implants, Guided Surgery, Digital Impression and CAD/CAM Technology: Clinical and Patient-centered Outcome.
To evaluate the overall treatment outcome of single implants installed with the assistance of fully guided-surgery, submitted to immediate loading with restorations fabricated with the help of intraoral scanning, during a 1-year follow-up period.
- Being tested
- Immediate loading, fully guided surgery and 3D printed restoration, Immediate loading
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate loading, fully guided surgery and 3D printed restorationProcedure or surgery
Fully guided surgery installation of single dental implants. 3D printed restorations that were immediate loaded.
Immediate loadingProcedure or surgery
Only subjected to immediate loading. Conventional procedure.
| Study group | Role | What they receive |
|---|---|---|
| Digital Immediate loading | Experimental | Single dental implant installed with the assistance of fully guided-surgery, submitted to immediate loading with restorations fabricated with the help of intraoral scanning and 3D printing Receives: Procedure: Immediate loading, fully guided surgery and 3D printed restoration |
| Immediate loading | Other | Historic cohort subjected to immediate loading Receives: Procedure: Immediate loading |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Implant Survival
Survival of dental implants. Implant survival means that implants are still in the mouth at the time of examination, regardless of the state of the prosthesis or patient satisfaction
Measured: 12 months
MBL
Marginal bone loss MBL, measured in mm from implant abutment junction.
Measured: 12 months
Pink Esthetic Score
Pink Esthetic Score (PES) Soft-tissue aesthetic scale. Range 0-14. Min = 0, aesthetic failure. Max = 14, almost prefect aesthetic outcome.
Measured: 12 months
White Esthetic Score
White Esthetic Score (WES) Dental crown/tooth aesthetic scale. Range 0-10. Min = 0, aesthetic failure. Max = 10, almost prefect aesthetic outcome.
Measured: 12 months
Oral Health Impact Profile - 14
Oral health impact profile - 14 (OHIP-14) Oral health related quality of life questioner. Score range 14-70. Low score indication good oral health related quality of life. High score indicates the opposite.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2019
- Study startNov 2016
- Primary completionMay 2019
- Study completionAug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Osseointegration Failure of Dental ImplantStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Folktandvården Skåne AB
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Björn Gjelvold, Folktandvården Skåne AB
- Investigators
- Ann Wennerberg, PhD, Study director, Göteborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04061694
- Sponsor's protocol ID
- DIL001
- Status last verified
- Mar 2020
- First submitted
- 16 Aug 2019
- Last updated
- 31 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- 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 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Loading of Single Implants, Guided Surgery, Digital Impression and CAD/CAM Technology: Clinical and Patient-centered Outcome.
- ClinicalTrials.gov ID
- NCT04061694
- Acronym / sponsor ID
- DIL001
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Folktandvården Skåne ABUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- May 2019 (actual)
- Study completion
- Aug 2019 (actual)
- First posted
- 20 Aug 2019 (actual)
- Results
- Posted 31 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the overall treatment outcome of single implants installed with the assistance of fully guided-surgery, submitted to immediate loading with restorations fabricated with the help of intraoral scanning, during a 1-year follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digital Immediate loading | Experimental | Procedure: Immediate loading, fully guided surgery and 3D printed restorationSingle dental implant installed with the assistance of fully guided-surgery, submitted to immediate loading with restorations fabricated with the help of intraoral scanning and 3D printing |
| Immediate loading | Other | Procedure: Immediate loadingHistoric cohort subjected to immediate loading |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- at least 18 years of age who had signed an informed consent
- in need of a single-tooth replacement of an incisor, canine or pre-molar in the maxilla.
Key exclusion criteria (3 listed)
- general contraindications for oral surgery
- patients with inadequate oral hygiene
- need for bone grafting or ridge augmentation.
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 |
|---|---|---|
| Immediate loading, fully guided surgery and 3D printed restorationFully guided surgery installation of single dental implants. 3D printed restorations that were immediate loaded. | Procedure or surgery | Digital Immediate loading |
| Immediate loadingOnly subjected to immediate loading. Conventional procedure. | Procedure or surgery | Immediate loading |
Primary outcome
Number of Participants With Implant Survival
Time frame: 12 months
Survival of dental implants. Implant survival means that implants are still in the mouth at the time of examination, regardless of the state of the prosthesis or patient satisfaction
MBL
Time frame: 12 months
Marginal bone loss MBL, measured in mm from implant abutment junction.
Pink Esthetic Score
Time frame: 12 months
Pink Esthetic Score (PES) Soft-tissue aesthetic scale. Range 0-14. Min = 0, aesthetic failure. Max = 14, almost prefect aesthetic outcome.
White Esthetic Score
Time frame: 12 months
White Esthetic Score (WES) Dental crown/tooth aesthetic scale. Range 0-10. Min = 0, aesthetic failure. Max = 10, almost prefect aesthetic outcome.
Oral Health Impact Profile - 14
Time frame: 12 months
Oral health impact profile - 14 (OHIP-14) Oral health related quality of life questioner. Score range 14-70. Low score indication good oral health related quality of life. High score indicates the opposite.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Osseointegration Failure of Dental Implant
Recruiting
Clinical and Radiographic Evaluation of UV-Treated Dental Implants With or Without Melatonin in the Upper Posterior Jaw
Jaw, Edentulous, Partially, Bone Resorption
Recruiting
Effect of Systemic Vitamin D on Dental Implant Osseointegration
Dental Implant, Dental Implant Failed
Enrolling by invitation
Prospective Longitudinal Clinical Study for the Evaluation of Peri-implant Tissue and Osseointegration After Rehabilitation With Osseointegrated Implants
Osseointegration Failure of Dental Implant, Periimplantitis
Active, not recruiting
Osseodensification Versus Conventional Drilling for Implant Site Preparation
Dental Implant Failed, Jaw, Edentulous, Partially
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.
Ann Wennerberg, PhD study director
Göteborg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate loading, fully guided surgery and 3D printed restoration and Immediate loading in people with Osseointegration Failure of Dental Implant, run by Folktandvården Skåne AB at 1 site in Sweden.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 31 Mar 2020. 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 Sweden. 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?
Yes. Results are posted in the registry (first posted 31 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Implant Survival (time frame: 12 months). The study lists 5 primary outcomes in all. 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 31 Mar 2020.