Dental Implant FailedimplantsNCT04236622
Clinical and Radiographic Evaluation of Dental Implants Installed Between 2004 and 2010
An observational study of Dental Implant Failed, run by Universidade Metropolitana de Santos at 1 site in Brazil.
Trial summary
The convenience sample to be included in the present study will consist of all individuals who had implants installed at the Dentistry Clinic of the University Santo Amaro, between the years 2004 and 2010. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Dental Implant Failed
- What is being tested?
- Periodontal clinical exam
- How many people
- 182 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jan 2016to 30 Oct 2019
- 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 30 to 70 years
- All sexes
- Adult, Older adult
Study population: Individuals of both genders, between 30 and 70 years of age, with implants placed from 2004 to 2010 will be included in the study.
Who may be able to join
- After evaluation, individuals may be allocated into groups according to the characteristics observed, for example: carriers of single implants, patients with overdentures, individuals with systemic diseases, smokers.
Who cannot join
- Individuals who need to use or suspend systemic medication to perform the proposed clinical exams will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
The convenience sample to be included in the present study will consist of all individuals who had implants installed at the Dentistry Clinic of the University Santo Amaro, between the years 2004 and 2010. The following criteria will be evaluated: age; sex; presence of systemic disease; area in which the implant was installed; implant diameter and height; type of prosthesis installed; presence of bone resorption and annual maintenance.
Read the detailed description
The control of biofilm around implants is fundamental to the success of implant therapy, and it is the duty of the dentist to inform, guide and maintain patients in order to avoid pathological processes that may lead to the loss of the implanted component. The objective of the present study will be to evaluate by clinical and radiographic parameters the condition of oral implants placed for more than five years. The convenience sample to be included in this study will be composed of all individuals who had implants installed at the Dental Clinic of the University Santo Amaro, between 2004 and 2010. The following criteria will be evaluated: age; sex; presence of systemic disease; area in which the implant was installed; implant diameter and height; type of prosthesis installed; presence of bone resorption and annual maintenance. The success and survival rate of implants through the following parameters: pain; mobility; card index (IP); bleeding rate (IS); probing depth (PS); probing bleeding (SS) that will be measured on four faces by implant: mesial, buccal, distal and lingual / palatine. For the evaluation of bone loss, a conventional periapical radiograph will be performed at the moment of patient recall. Radiographs will be scanned and analyzed using Image Tool software to verify and determine the resulting linear distance between the implant shoulder and the bone crest. Factors such as smoking, annual maintenance appointments will be related to the presence of peri-implantitis.
- Conditions
- Dental Implant Failed
- Being tested
- Periodontal clinical exam
- Keywords
- dental implants, periodontal index, peri-implantitis
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periodontal clinical examOther
Also called Radiographic exam
The individuals will be submitted to a complete periodontal examination, with measurements obtained at four points per tooth and dental implant (mesial, distal, buccal and lingual / palatal), in all teeth / implants present, except for the third molars, the parameters evaluated will be: Probing Depth, Clinical Insertion Level, Plaque Index, Teeth Bleeding Index. The implants will be evaluated according to the parameters: presence of suppuration, probing depth, bleeding to probing and presence of biofilm around the implants. To perform the clinical examinations, the following instruments will be required: Willians millimeter probe, exploratory probe and clinical mirror.
In all participants, complete periapical radiographic examinations with 14 radiographs will be performed to verify the bone cortical height level and to assist in the periodontal diagnosis.
| Study group | Role | What they receive |
|---|---|---|
| Health | For each patient we evaluated the Probing Depth (PD), measured in mm, and the following dichotomous variables: plaque index (absent or present), gingival index (absent or present), occurrence of annual maintenance (absent or present), tooth position (anterior or posterior) and the patient's smoking habit (absent or present). Receives: Other: Periodontal clinical exam | |
| Peri-implantitis | For each patient we evaluated the Probing Depth (PD), measured in mm, and the following dichotomous variables: plaque index (absent or present), gingival index (absent or present), occurrence of annual maintenance (absent or present), tooth position (anterior or posterior) and the patient's smoking habit (absent or present). Receives: Other: Periodontal clinical exam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing depth
lower probing depth in patients who underwent annual maintenance
Measured: 10 years
Secondary outcomes (1)
Plaque control
lower plaque index in patients who underwent annual maintenance
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2020
- Study start1 Jan 2016
- Primary completion10 Feb 2016
- Study completion30 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Metropolitana de Santos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CAIO VINICIUS G. ROMAN TORRES, Universidade Metropolitana de Santos
- Investigators
- CAIO VINICIUS G ROMAN TORRES, PhD, Principal investigator, University of South Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04236622
- Sponsor's protocol ID
- SantosMU6
- Acronym
- implants
- Status last verified
- Jan 2020
- First submitted
- 17 Jan 2020
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: The IPD will not be shared with other researchers. The study participants allowed the use of data only for this study and for this researcher
Publications
van Velzen FJ, Ofec R, Schulten EA, Ten Bruggenkate CM. 10-year survival rate and the incidence of peri-implant disease of 374 titanium dental implants with a SLA surface: a prospective cohort study in 177 fully and partially edentulous patients. Clin Oral Implants Res. 2015 Oct;26(10):1121-8. doi: 10.1111/clr.12499. Epub 2014 Nov 5.
PubMed 25370914Bergenblock S, Andersson B, Furst B, Jemt T. Long-term follow-up of CeraOne single-implant restorations: an 18-year follow-up study based on a prospective patient cohort. Clin Implant Dent Relat Res. 2012 Aug;14(4):471-9. doi: 10.1111/j.1708-8208.2010.00290.x. Epub 2010 Jun 25.
PubMed 20586784Albrektsson T, Dahlin C, Jemt T, Sennerby L, Turri A, Wennerberg A. Is marginal bone loss around oral implants the result of a provoked foreign body reaction? Clin Implant Dent Relat Res. 2014 Apr;16(2):155-65. doi: 10.1111/cid.12142. Epub 2013 Sep 4.
PubMed 24004092
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Dental Implants Installed Between 2004 and 2010
- ClinicalTrials.gov ID
- NCT04236622
- Acronym / sponsor ID
- implants / SantosMU6
- Conditions
- Dental Implant Failed
- Keywords
- dental implants, periodontal index, peri-implantitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Universidade Metropolitana de SantosUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 10 Feb 2016 (actual)
- Study completion
- 30 Oct 2019 (actual)
- First posted
- 22 Jan 2020 (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.
The convenience sample to be included in the present study will consist of all individuals who had implants installed at the Dentistry Clinic of the University Santo Amaro, between the years 2004 and 2010. The following criteria will be evaluated: age; sex; presence of systemic disease; area in which the implant was installed; implant diameter and height; type of prosthesis installed; presence of bone resorption and annual maintenance.
Detailed description
The control of biofilm around implants is fundamental to the success of implant therapy, and it is the duty of the dentist to inform, guide and maintain patients in order to avoid pathological processes that may lead to the loss of the implanted component. The objective of the present study will be to evaluate by clinical and radiographic parameters the condition of oral implants placed for more than five years. The convenience sample to be included in this study will be composed of all individuals who had implants installed at the Dental Clinic of the University Santo Amaro, between 2004 and 2010. The following criteria will be evaluated: age; sex; presence of systemic disease; area in which the implant was installed; implant diameter and height; type of prosthesis installed; presence of bone resorption and annual maintenance. The success and survival rate of implants through the following parameters: pain; mobility; card index (IP); bleeding rate (IS); probing depth (PS); probing bleeding (SS) that will be measured on four faces by implant: mesial, buccal, distal and lingual / palatine. For the evaluation of bone loss, a conventional periapical radiograph will be performed at the moment of patient recall. Radiographs will be scanned and analyzed using Image Tool software to verify and determine the resulting linear distance between the implant shoulder and the bone crest. Factors such as smoking, annual maintenance appointments will be related to the presence of peri-implantitis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Health | – | Other: Periodontal clinical examFor each patient we evaluated the Probing Depth (PD), measured in mm, and the following dichotomous variables: plaque index (absent or present), gingival index (absent or present), occurrence of annual maintenance (absent or present), tooth position (anterior or posterior) and the patient's smoking habit (absent or present). |
| Peri-implantitis | – | Other: Periodontal clinical examFor each patient we evaluated the Probing Depth (PD), measured in mm, and the following dichotomous variables: plaque index (absent or present), gingival index (absent or present), occurrence of annual maintenance (absent or present), tooth position (anterior or posterior) and the patient's smoking habit (absent or present). |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Individuals of both genders, between 30 and 70 years of age, with implants placed from 2004 to 2010 will be included in the study.
Key inclusion criteria (1 listed)
- After evaluation, individuals may be allocated into groups according to the characteristics observed, for example: carriers of single implants, patients with overdentures, individuals with systemic diseases, smokers.
Key exclusion criteria (1 listed)
- Individuals who need to use or suspend systemic medication to perform the proposed clinical exams will be excluded from the study.
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 |
|---|---|---|
| Periodontal clinical examAlso: Radiographic examThe individuals will be submitted to a complete periodontal examination, with measurements obtained at four points per tooth and dental implant (mesial, distal, buccal and lingual / palatal), in all teeth / implants present, except for the third molars, the parameters evaluated will be: Probing Depth, Clinical Insertion Level, Plaque Index, Teeth Bleeding Index. The implants will be evaluated according to the parameters: presence of suppuration, probing depth, bleeding to probing and presence of biofilm around the implants. To perform the clinical examinations, the following instruments will be required: Willians millimeter probe, exploratory probe and clinical mirror. In all participants, complete periapical radiographic examinations with 14 radiographs will be performed to verify the bone cortical height level and to assist in the periodontal diagnosis. | Other | Health, Peri-implantitis |
Primary outcome
Probing depth
Time frame: 10 years
lower probing depth in patients who underwent annual maintenance
1 secondary outcome
Plaque control
Time frame: 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
- Results publication: PubMed 25370914van Velzen FJ, Ofec R, Schulten EA, Ten Bruggenkate CM. 10-year survival rate and the incidence of peri-implant disease of 374 titanium dental implants with a SLA surface: a prospective cohort study in 177 fully and partially edentulous patients. Clin Oral Implants Res. 2015 Oct;26(10):1121-8. doi: 10.1111/clr.12499. Epub 2014 Nov 5.
- Results publication: PubMed 20586784Bergenblock S, Andersson B, Furst B, Jemt T. Long-term follow-up of CeraOne single-implant restorations: an 18-year follow-up study based on a prospective patient cohort. Clin Implant Dent Relat Res. 2012 Aug;14(4):471-9. doi: 10.1111/j.1708-8208.2010.00290.x. Epub 2010 Jun 25.
- Results publication: PubMed 24004092Albrektsson T, Dahlin C, Jemt T, Sennerby L, Turri A, Wennerberg A. Is marginal bone loss around oral implants the result of a provoked foreign body reaction? Clin Implant Dent Relat Res. 2014 Apr;16(2):155-65. doi: 10.1111/cid.12142. Epub 2013 Sep 4.
- Individual participant dataSharing planned: No. The IPD will not be shared with other researchers. The study participants allowed the use of data only for this study and for this researcher
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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.
CAIO VINICIUS G ROMAN TORRES, PhD principal investigator
University of South Australia
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, run by Universidade Metropolitana de Santos at 1 site in Brazil.
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 1 inclusion and 1 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 27 Jan 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 Brazil. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Probing depth (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04236622, which also lists 3 linked publications.
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 27 Jan 2020.