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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • Brazil
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Other: peri-implant examination
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.
Other: peri-implant examination
The prostheses were removed and all implants were evaluated: probing depth, plaque index and bleeding index.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidade Metropolitana de Santos

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 5, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 27, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 30, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 30, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 27, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SANTOSMU02

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