Failure of Dental Implant Due to Lack of Attached GingivaNCT02511977
Evaluation Clinical and Radiographic Images in Dental Implants Rehabilitated With Overdentures
An observational study of Failure of Dental Implant Due to Lack of Attached Gingiva and Failure of Dental Prosthesis Causing Loss of Dental Implant, run by Universidade Metropolitana de Santos at 1 site in Brazil.
Trial summary
The control of biofilm around implants is critical to the success of the implant rehabilitation of edentulous jaw with overdentures, and it is the dentist's duty to inform and guide patients, and keep their maintenance in order to prevent pathological processes that can lead to the implanted component loss.The aim of… Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Failure of Dental Implant Due to Lack of Attached Gingiva, Failure of Dental Prosthesis Causing Loss of Dental Implant
- What is being tested?
- peri-implant examination
- How many people
- 64 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2013to Feb 2015
- 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 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Initially, 80 individuals who underwent the installation of dental implants for making overdentures in the Department of Implant Dentistry, Faculty of Dentistry, University of Santo Amaro, São Paulo, Brazil, in 2007,were evaluated.According to the inclusion and exclusion criteria, the final sample had 64 individuals of both genders, between 40 and 75 years old
Who may be able to join
- Rehabilitation should be:prothesis type overdenture, with at least 2 implants placed in the mandible and 3 implants in the maxilla per person
- individuals who have annual maintenance for the past seven years,
- individuals who have not returned for the last seven years,
- Individuals who said they went to the dentist at least once a year, for whatever treatment, were included in the maintenance group,
- Individuals who denied any visit to the dentist in the last seven years were included in the no maintenance group.
Who cannot join
- smokers,
- as those who, for any reason, should make systemic medication suspension for clinical evaluation,
- individuals in need of antibiotic prophylaxis for carrying out the clinical examinations,
- Patients with less than seven annual maintenance consultations in the last seven years
Trial locations and contacts
1 site in 1 country.
About this study
The control of biofilm around implants is critical to the success of the implant rehabilitation of edentulous jaw with overdentures, and it is the dentist's duty to inform and guide patients, and keep their maintenance in order to prevent pathological processes that can lead to the implanted component loss.The aim of the present retrospective longitudinal study was to evaluate through clinical periodontal parameters and radiographic images in dental implants rehabilitated with overdentures installed seven years ago. individuals who underwent the installation of dental implants for making full implant-supported upper and lower mucus dentures in the Department of Implant Dentistry, Faculty of Dentistry, University of Santo Amaro, São Paulo, Brazil, in 2007. The periodontal parameters such as probing depth, plaque index, bleeding index and mobility as well as radiographic examination, are key to determine the correct diagnosis in dental implants. The control of biofilm around the implants seems to be a decisive factor for maintaining tissue health. We believe that the maintenance appointments are fundamental, but more studies should be conducted to elucidate microbial and immunological factors in implants placed and due for some time.
Read the detailed description
The control of biofilm around implants is critical to the success of the implant rehabilitation of edentulous jaw with overdentures, and it is the dentist's duty to inform and guide patients, and keep their maintenance in order to prevent pathological processes that can lead to the implanted component loss.The aim of the present retrospective longitudinal study was to evaluate through clinical periodontal parameters and radiographic images in dental implants rehabilitated with overdentures installed seven years ago. individuals who underwent the installation of dental implants for making full implant-supported upper and lower mucus dentures in the Department of Implant Dentistry, Faculty of Dentistry, University of Santo Amaro, São Paulo, Brazil, in 2007. The periodontal parameters such as probing depth, plaque index, bleeding index and mobility as well as radiographic examination, are key to determine the correct diagnosis in dental implants. The control of biofilm around the implants seems to be a decisive factor for maintaining tissue health.
- Conditions
- Failure of Dental Implant Due to Lack of Attached Gingiva, Failure of Dental Prosthesis Causing Loss of Dental Implant
- Being tested
- peri-implant examination
- Keywords
- Dental Prosthesis, Implant-Supported
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
peri-implant examinationOther
The prostheses were removed and all implants were evaluated: probing depth, plaque index and bleeding index.
| Study group | Role | What they receive |
|---|---|---|
| overdenture with annual maintenance | Rehabilitation should be: overdenture with at least 2 implants placed in the mandible and 3 implants in the maxilla per person. They were divided into two groups: Group I: Annual maintenance for the past seven years Receives: Other: peri-implant examination | |
| overdenture whitout annual maintenance | Group II: individuals who have not returned for the last seven years. Individuals who said they went to the dentist at least once a year, for whatever treatment, were included in the maintenance group. Individuals who denied any visit to the dentist in the last seven years were included in the no maintenance group. Receives: Other: peri-implant examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
probing depth in implants
individuals who underwent the installation of dental implants for making full upper and lower overdentures in 2007
Measured: 7 years
Secondary outcomes (2)
gingival index (GI)
individuals who underwent the installation of dental implants for making full upper and lower overdentures in 2007
Measured: 7 years
plaque index (PI)
individuals who underwent the installation of dental implants for making full upper and lower overdentures in 2007
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2015 (estimated)
- Study startApr 2013
- Primary completionNov 2013
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Failure of Dental Implant Due to Lack of Attached GingivaStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Metropolitana de Santos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CAIO VINICIUS GONÇALVES ROMAN TORRES, Universidade Metropolitana de Santos
- Investigators
- Caio VG Roman-Torres, PhD, Principal investigator, University of South Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02511977
- Sponsor's protocol ID
- SANTOSMU02
- Status last verified
- Jul 2015
- First submitted
- 5 Jun 2015
- Last updated
- 30 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Meijer HJ, Raghoebar GM, de Waal YC, Vissink A. Incidence of peri-implant mucositis and peri-implantitis in edentulous patients with an implant-retained mandibular overdenture during a 10-year follow-up period. J Clin Periodontol. 2014 Dec;41(12):1178-83. doi: 10.1111/jcpe.12311. Epub 2014 Nov 1.
PubMed 25229397Parmar S, Karir N, Walmsley D, Patel U. Long and short term management of implant-supported mandibular overdentures. Dent Update. 2013 Dec;40(10):830-2, 834-5. doi: 10.12968/denu.2013.40.10.830.
PubMed 24597027Troeltzsch M, Troeltzsch V, Brodine AH, Frankenberger R, Messlinger K, Troeltzsch M. Clinical performance and peri-implant parameters of 132 implants supporting locator-retained overdentures: a case series of 33 patients. Int J Oral Maxillofac Implants. 2013 Jul-Aug;28(4):1132-9. doi: 10.11607/jomi.3009.
PubMed 23869372Akca K, Cehreli MC, Uysal S. Marginal bone loss and prosthetic maintenance of bar-retained implant-supported overdentures: a prospective study. Int J Oral Maxillofac Implants. 2010 Jan-Feb;25(1):137-45.
PubMed 20209196Cehreli MC, Uysal S, Akca K. Marginal bone level changes and prosthetic maintenance of mandibular overdentures supported by 2 implants: a 5-year randomized clinical trial. Clin Implant Dent Relat Res. 2010 Jun 1;12(2):114-21. doi: 10.1111/j.1708-8208.2008.00143.x. Epub 2009 Feb 13.
PubMed 19220845
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Clinical and Radiographic Images in Dental Implants Rehabilitated With Overdentures
- ClinicalTrials.gov ID
- NCT02511977
- Acronym / sponsor ID
- SANTOSMU02
- Conditions
- Failure of Dental Implant Due to Lack of Attached Gingiva, Failure of Dental Prosthesis Causing Loss of Dental Implant
- Keywords
- Dental Prosthesis, Implant-Supported
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Universidade Metropolitana de SantosUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 30 Jul 2015 (estimated)
- 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 control of biofilm around implants is critical to the success of the implant rehabilitation of edentulous jaw with overdentures, and it is the dentist's duty to inform and guide patients, and keep their maintenance in order to prevent pathological processes that can lead to the implanted component loss.The aim of the present retrospective longitudinal study was to evaluate through clinical periodontal parameters and radiographic images in dental implants rehabilitated with overdentures installed seven years ago. individuals who underwent the installation of dental implants for making full implant-supported upper and lower mucus dentures in the Department of Implant Dentistry, Faculty of Dentistry, University of Santo Amaro, São Paulo, Brazil, in 2007. The periodontal parameters such as probing depth, plaque index, bleeding index and mobility as well as radiographic examination, are key to determine the correct diagnosis in dental implants. The control of biofilm around the implants seems to be a decisive factor for maintaining tissue health. We believe that the maintenance appointments are fundamental, but more studies should be conducted to elucidate microbial and immunological factors in implants placed and due for some time.
Detailed description
The control of biofilm around implants is critical to the success of the implant rehabilitation of edentulous jaw with overdentures, and it is the dentist's duty to inform and guide patients, and keep their maintenance in order to prevent pathological processes that can lead to the implanted component loss.The aim of the present retrospective longitudinal study was to evaluate through clinical periodontal parameters and radiographic images in dental implants rehabilitated with overdentures installed seven years ago. individuals who underwent the installation of dental implants for making full implant-supported upper and lower mucus dentures in the Department of Implant Dentistry, Faculty of Dentistry, University of Santo Amaro, São Paulo, Brazil, in 2007. The periodontal parameters such as probing depth, plaque index, bleeding index and mobility as well as radiographic examination, are key to determine the correct diagnosis in dental implants. The control of biofilm around the implants seems to be a decisive factor for maintaining tissue health.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| overdenture with annual maintenance | – | Other: peri-implant examinationRehabilitation should be: overdenture with at least 2 implants placed in the mandible and 3 implants in the maxilla per person. They were divided into two groups: Group I: Annual maintenance for the past seven years |
| overdenture whitout annual maintenance | – | Other: peri-implant examinationGroup II: individuals who have not returned for the last seven years. Individuals who said they went to the dentist at least once a year, for whatever treatment, were included in the maintenance group. Individuals who denied any visit to the dentist in the last seven years were included in the no maintenance group. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Initially, 80 individuals who underwent the installation of dental implants for making overdentures in the Department of Implant Dentistry, Faculty of Dentistry, University of Santo Amaro, São Paulo, Brazil, in 2007,were evaluated.According to the inclusion and exclusion criteria, the final sample had 64 individuals of both genders, between 40 and 75 years old
Key inclusion criteria (5 listed)
- Rehabilitation should be:prothesis type overdenture, with at least 2 implants placed in the mandible and 3 implants in the maxilla per person
- individuals who have annual maintenance for the past seven years,
- individuals who have not returned for the last seven years,
- Individuals who said they went to the dentist at least once a year, for whatever treatment, were included in the maintenance group,
- Individuals who denied any visit to the dentist in the last seven years were included in the no maintenance group.
Key exclusion criteria (4 listed)
- smokers,
- as those who, for any reason, should make systemic medication suspension for clinical evaluation,
- individuals in need of antibiotic prophylaxis for carrying out the clinical examinations,
- Patients with less than seven annual maintenance consultations in the last seven years
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 |
|---|---|---|
| peri-implant examinationThe prostheses were removed and all implants were evaluated: probing depth, plaque index and bleeding index. | Other | overdenture whitout annual maintenance, overdenture with annual maintenance |
Primary outcome
probing depth in implants
Time frame: 7 years
individuals who underwent the installation of dental implants for making full upper and lower overdentures in 2007
2 secondary outcomes
gingival index (GI)
Time frame: 7 years
plaque index (PI)
Time frame: 7 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 30 Jul 2015.
- Results publication: PubMed 25229397Meijer HJ, Raghoebar GM, de Waal YC, Vissink A. Incidence of peri-implant mucositis and peri-implantitis in edentulous patients with an implant-retained mandibular overdenture during a 10-year follow-up period. J Clin Periodontol. 2014 Dec;41(12):1178-83. doi: 10.1111/jcpe.12311. Epub 2014 Nov 1.
- Results publication: PubMed 24597027Parmar S, Karir N, Walmsley D, Patel U. Long and short term management of implant-supported mandibular overdentures. Dent Update. 2013 Dec;40(10):830-2, 834-5. doi: 10.12968/denu.2013.40.10.830.
- Results publication: PubMed 23869372Troeltzsch M, Troeltzsch V, Brodine AH, Frankenberger R, Messlinger K, Troeltzsch M. Clinical performance and peri-implant parameters of 132 implants supporting locator-retained overdentures: a case series of 33 patients. Int J Oral Maxillofac Implants. 2013 Jul-Aug;28(4):1132-9. doi: 10.11607/jomi.3009.
- Results publication: PubMed 20209196Akca K, Cehreli MC, Uysal S. Marginal bone loss and prosthetic maintenance of bar-retained implant-supported overdentures: a prospective study. Int J Oral Maxillofac Implants. 2010 Jan-Feb;25(1):137-45.
- Results publication: PubMed 19220845Cehreli MC, Uysal S, Akca K. Marginal bone level changes and prosthetic maintenance of mandibular overdentures supported by 2 implants: a 5-year randomized clinical trial. Clin Implant Dent Relat Res. 2010 Jun 1;12(2):114-21. doi: 10.1111/j.1708-8208.2008.00143.x. Epub 2009 Feb 13.
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 VG 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 Failure of Dental Implant Due to Lack of Attached Gingiva and Failure of Dental Prosthesis Causing Loss of Dental Implant, 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 5 inclusion and 4 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 30 Jul 2015. 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 in implants (time frame: 7 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 NCT02511977, which also lists 5 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 30 Jul 2015.