Clinical trial NCT04236622: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dental Implant Failed
Keywords: dental implants
periodontal index
peri-implantitis
Lead sponsor: Universidade Metropolitana de Santos
Sponsor class: OTHER
First posted: 2020-01-22
Enrollment: 182
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Probing depth
timeFrame: 10 years
Secondary outcomes:
measure: Plaque control
timeFrame: 10 years
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: University of Santo Amaro - UNISA/SP
state: SP
Study officials:
affiliation: University of South Australia
name: CAIO VINICIUS G ROMAN TORRES, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: van Velzen FJ, Ofec R, Schulten EA, Ten Bruggenkate CM. 10-year survival rate and the incidence of peri-implant disease of 374 titanium dental implants with a SLA surface: a prospective cohort study in 177 fully and partially edentulous patients. Clin Oral Implants Res. 2015 Oct;26(10):1121-8. doi: 10.1111/clr.12499. Epub 2014 Nov 5.
citation: Bergenblock S, Andersson B, Furst B, Jemt T. Long-term follow-up of CeraOne single-implant restorations: an 18-year follow-up study based on a prospective patient cohort. Clin Implant Dent Relat Res. 2012 Aug;14(4):471-9. doi: 10.1111/j.1708-8208.2010.00290.x. Epub 2010 Jun 25.
citation: Albrektsson T, Dahlin C, Jemt T, Sennerby L, Turri A, Wennerberg A. Is marginal bone loss around oral implants the result of a provoked foreign body reaction? Clin Implant Dent Relat Res. 2014 Apr;16(2):155-65. doi: 10.1111/cid.12142. Epub 2013 Sep 4.