- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02511977
Evaluation Clinical and Radiographic Images in Dental Implants Rehabilitated With Overdentures
July 27, 2015 updated by: CAIO VINICIUS GONÇALVES ROMAN TORRES, Universidade Metropolitana de Santos
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
64
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
SP
-
São Paulo, SP, Brazil
- University of Santo Amaro - UNISA/SP
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
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
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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
|
The prostheses were removed and all implants were evaluated: probing depth, plaque index and bleeding index.
|
|
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.
|
The prostheses were removed and all implants were evaluated: probing depth, plaque index and bleeding index.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
7 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
gingival index (GI)
Time Frame: 7 years
|
individuals who underwent the installation of dental implants for making full upper and lower overdentures in 2007
|
7 years
|
|
plaque index (PI)
Time Frame: 7 years
|
individuals who underwent the installation of dental implants for making full upper and lower overdentures in 2007
|
7 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Caio VG Roman-Torres, PhD, University of South Australia
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Parmar 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.
- Troeltzsch 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.
- Akca 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.
- Cehreli 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2013
Primary Completion (Actual)
November 1, 2013
Study Completion (Actual)
February 1, 2015
Study Registration Dates
First Submitted
June 5, 2015
First Submitted That Met QC Criteria
July 27, 2015
First Posted (Estimate)
July 30, 2015
Study Record Updates
Last Update Posted (Estimate)
July 30, 2015
Last Update Submitted That Met QC Criteria
July 27, 2015
Last Verified
July 1, 2015
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- SANTOSMU02
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Failure of Dental Implant Due to Lack of Attached Gingiva
-
University of Maryland, BaltimoreCompletedFailure of Dental Implant Due to Lack of Attached GingivaUnited States
-
Implantology InstituteUnknownOsseointegration Failure of Dental Implant Due to Infection | Osseointegration Failure of Dental Implant Prior to Intentional Prosthetic Loading
-
University of Alabama at BirminghamRecruitingGingival Recession | Thin Gingiva | Lack of Keratinized Attached Peri-implant MucosaUnited States
-
Istanbul Medipol University HospitalCompletedDental Implant Failed | Osseointegration Failure of Dental ImplantTurkey
-
University of Sao PauloCompletedDental Implant Failed | Pre-osseointegration Failure of Dental ImplantBrazil
-
Rambam Health Care CampusCompletedFailure of Osseointegration of Dental ImplantIsrael
-
University of Dublin, Trinity CollegeRecruitingOsseointegration Failure of Dental ImplantIreland
-
Ziauddin UniversityCompletedOsseointegration Failure of Dental ImplantPakistan
-
Minia UniversityCompletedOsseointegration Failure of Dental ImplantEgypt
-
Folktandvården Skåne ABCompletedOsseointegration Failure of Dental ImplantSweden
Clinical Trials on peri-implant examination
-
McGill University Health Centre/Research Institute...RecruitingDental Implant Failed | Implant Complication | Implant Site Reaction | Implant Site InfectionCanada
-
Inonu UniversityCompletedPeri-implantitis | Peri-implant Mucositis | Peri-Implant HealthTurkey (Türkiye)
-
McGill UniversityMcGill University Health Centre/Research Institute of the McGill University...Enrolling by invitationHypersensitivity | Peri-Implantitis | Peri-implant Mucositis | Implant Site Reaction | Implant Site Infection | Implant Infection | Implant Site RashCanada
-
Hanna LahteenmakiUniversity of HelsinkiEnrolling by invitationPeri-Implantitis and Peri-implant Mucositis | Peri-Implant HealthFinland
-
University of PittsburghEnrolling by invitationPeri-Implantitis | Peri-implant MucositisUnited States
-
Vilniaus Implantologijos Centro (VIC) KlinikaCompletedPeri-implantitis | Peri-Implantational Loss | Peri-Implantation Loss | Peri-Implant HealthLithuania
-
Arrow DevelopmentSalud y Estetica Dental SCH Zurbano S.L; Clinica Dental Nexus, Malaga; Clinica... and other collaboratorsNot yet recruitingPeri-implantitis | Peri-implant Bone Loss
-
University of ManitobaCompletedDetermination of Clinical Effects | Presence of Inflammatory Cytokines | Patients Perception of Discomfort | Titanium Scalers | UltrasonicsCanada
-
Medical University of GrazCompleted
-
Dr. Mehmet Selim YildizCompletedDental Implantation | Peri-implant Mucositis | Orthodontics | Gingival Inflammation | Implant StabilityTurkey