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

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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

Tracking Information
First Submitted Date January 17, 2020
First Posted Date January 22, 2020
Last Update Posted Date January 27, 2020
Actual Study Start Date January 1, 2016
Actual Primary Completion Date February 10, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 21, 2020)
Probing depth [ Time Frame: 10 years ]
lower probing depth in patients who underwent annual maintenance
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: January 21, 2020)
Plaque control [ Time Frame: 10 years ]
lower plaque index in patients who underwent annual maintenance
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Clinical and Radiographic Evaluation of Dental Implants Installed Between 2004 and 2010
Official Title Clinical and Radiographic Evaluation of Dental Implants Installed Between 2004 and 2010
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.
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
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Dental Implant Failed
Intervention 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
Study Groups/Cohorts
  • 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).
    Intervention: Other: Periodontal clinical 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).
    Intervention: Other: Periodontal clinical exam
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 21, 2020)
182
Original Actual Enrollment Same as current
Actual Study Completion Date October 30, 2019
Actual Primary Completion Date February 10, 2016   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 30 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Brazil
Removed Location Countries  
 
Administrative Information
NCT Number NCT04236622
Other Study ID Numbers SantosMU6
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Device Product: No
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
Responsible Party CAIO VINICIUS G. ROMAN TORRES, Universidade Metropolitana de Santos
Study Sponsor Universidade Metropolitana de Santos
Collaborators Not Provided
Investigators
Principal Investigator: CAIO VINICIUS G ROMAN TORRES, PhD University of South Australia
PRS Account Universidade Metropolitana de Santos
Verification Date January 2020