Clinical and Radiographic Evaluation of Dental Implants Installed Between 2004 and 2010 (implants)

January 23, 2020 updated by: CAIO VINICIUS G. ROMAN TORRES, Universidade Metropolitana de Santos
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

182

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

Ages Eligible for Study

30 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Individuals who need to use or suspend systemic medication to perform the proposed clinical exams will be excluded from the study.

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
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).
Other: Periodontal clinical 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.

Other Names:
  • Radiographic 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).
Other: Periodontal clinical 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.

Other Names:
  • Radiographic exam

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Probing depth
Time Frame: 10 years
lower probing depth in patients who underwent annual maintenance
10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plaque control
Time Frame: 10 years
lower plaque index in patients who underwent annual maintenance
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Metropolitana de Santos

Investigators

  • Principal Investigator: CAIO VINICIUS G 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 (ACTUAL)

January 1, 2016

Primary Completion (ACTUAL)

February 10, 2016

Study Completion (ACTUAL)

October 30, 2019

Study Registration Dates

First Submitted

January 17, 2020

First Submitted That Met QC Criteria

January 21, 2020

First Posted (ACTUAL)

January 22, 2020

Study Record Updates

Last Update Posted (ACTUAL)

January 27, 2020

Last Update Submitted That Met QC Criteria

January 23, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SantosMU6

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

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.

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