Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04236622
Recruitment Status : Completed
First Posted : January 22, 2020
Last Update Posted : January 27, 2020
Sponsor:
Information provided by (Responsible Party):
CAIO VINICIUS G. ROMAN TORRES, Universidade Metropolitana de Santos

Brief 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. 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.

Condition or disease Intervention/treatment
Dental Implant Failed Other: Periodontal clinical exam

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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 182 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Clinical and Radiographic Evaluation of Dental Implants Installed Between 2004 and 2010
Actual Study Start Date : January 1, 2016
Actual Primary Completion Date : February 10, 2016
Actual Study Completion Date : October 30, 2019

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 Name: 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 Name: Radiographic exam




Primary Outcome Measures :
  1. Probing depth [ Time Frame: 10 years ]
    lower probing depth in patients who underwent annual maintenance


Secondary Outcome Measures :
  1. Plaque control [ Time Frame: 10 years ]
    lower plaque index in patients who underwent annual maintenance



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes 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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04236622


Locations
Layout table for location information
Brazil
University of Santo Amaro - UNISA/SP
São Paulo, SP, Brazil
Sponsors and Collaborators
Universidade Metropolitana de Santos
Investigators
Layout table for investigator information
Principal Investigator: CAIO VINICIUS G ROMAN TORRES, PhD University of South Australia

Publications of Results:
Layout table for additonal information
Responsible Party: CAIO VINICIUS G. ROMAN TORRES, Professor, Universidade Metropolitana de Santos
ClinicalTrials.gov Identifier: NCT04236622    
Other Study ID Numbers: SantosMU6
First Posted: January 22, 2020    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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

Layout table for additional information
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by CAIO VINICIUS G. ROMAN TORRES, Universidade Metropolitana de Santos:
dental implants
periodontal index
peri-implantitis