Clinical and Radiographic Evaluation of Dental Implants Installed Between 2004 and 2010

Dental Implant Failed Clinical Trial

— implants  

Official title:

Clinical and Radiographic Evaluation of Dental Implants Installed Between 2004 and 2010

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04236622
• Other study ID #: SantosMU6
• Status: Completed
• Start date: January 1, 2016
• Est. completion date: October 30, 2019

Study information

• Verified date: January 2020
• Source: Universidade Metropolitana de Santos
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 182
• Est. completion date: October 30, 2019
• Est. primary completion date: February 10, 2016
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• 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.

Locations

Country	Name	City	State
Brazil	University of Santo Amaro - UNISA/SP	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Metropolitana de Santos

Country where clinical trial is conducted

Brazil, 

References & Publications (3)

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. Rev — View Citation

Bergenblock S, Andersson B, Fürst 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.1708-8208.2010.00 — View 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 Ora — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Probing depth	lower probing depth in patients who underwent annual maintenance	10 years
Secondary	Plaque control	lower plaque index in patients who underwent annual maintenance	10 years