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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02511977
Other study ID # SANTOSMU02
Secondary ID
Status Completed
Phase N/A
First received June 5, 2015
Last updated July 27, 2015
Start date April 2013
Est. completion date February 2015

Study information

Verified date July 2015
Source Santos Metropolitan University
Contact n/a
Is FDA regulated No
Health authority Brazil: Ethics Committee
Study type Observational

Clinical Trial Summary

The control of biofilm around implants is critical to the success of the implant rehabilitation of edentulous jaw with overdentures, and it is the dentist's duty to inform and guide patients, and keep their maintenance in order to prevent pathological processes that can lead to the implanted component loss.The aim of the present retrospective longitudinal study was to evaluate through clinical periodontal parameters and radiographic images in dental implants rehabilitated with overdentures installed seven years ago. individuals who underwent the installation of dental implants for making full implant-supported upper and lower mucus dentures in the Department of Implant Dentistry, Faculty of Dentistry, University of Santo Amaro, São Paulo, Brazil, in 2007. The periodontal parameters such as probing depth, plaque index, bleeding index and mobility as well as radiographic examination, are key to determine the correct diagnosis in dental implants. The control of biofilm around the implants seems to be a decisive factor for maintaining tissue health. We believe that the maintenance appointments are fundamental, but more studies should be conducted to elucidate microbial and immunological factors in implants placed and due for some time.


Description:

The control of biofilm around implants is critical to the success of the implant rehabilitation of edentulous jaw with overdentures, and it is the dentist's duty to inform and guide patients, and keep their maintenance in order to prevent pathological processes that can lead to the implanted component loss.The aim of the present retrospective longitudinal study was to evaluate through clinical periodontal parameters and radiographic images in dental implants rehabilitated with overdentures installed seven years ago. individuals who underwent the installation of dental implants for making full implant-supported upper and lower mucus dentures in the Department of Implant Dentistry, Faculty of Dentistry, University of Santo Amaro, São Paulo, Brazil, in 2007. The periodontal parameters such as probing depth, plaque index, bleeding index and mobility as well as radiographic examination, are key to determine the correct diagnosis in dental implants. The control of biofilm around the implants seems to be a decisive factor for maintaining tissue health.


Recruitment information / eligibility

Status Completed
Enrollment 64
Est. completion date February 2015
Est. primary completion date November 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 40 Years to 75 Years
Eligibility Inclusion Criteria:

- Rehabilitation should be:prothesis type overdenture, with at least 2 implants placed in the mandible and 3 implants in the maxilla per person

- individuals who have annual maintenance for the past seven years,

- individuals who have not returned for the last seven years,

- Individuals who said they went to the dentist at least once a year, for whatever treatment, were included in the maintenance group,

- Individuals who denied any visit to the dentist in the last seven years were included in the no maintenance group.

Exclusion Criteria:

- smokers,

- as those who, for any reason, should make systemic medication suspension for clinical evaluation,

- individuals in need of antibiotic prophylaxis for carrying out the clinical examinations,

- Patients with less than seven annual maintenance consultations in the last seven years

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective


Related Conditions & MeSH terms

  • Failure of Dental Implant Due to Lack of Attached Gingiva
  • Failure of Dental Prosthesis Causing Loss of Dental Implant

Intervention

Other:
peri-implant examination
The prostheses were removed and all implants were evaluated: probing depth, plaque index and bleeding index.

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Santos Metropolitan University

Country where clinical trial is conducted

Brazil, 

References & Publications (5)

Akca K, Cehreli MC, Uysal S. Marginal bone loss and prosthetic maintenance of bar-retained implant-supported overdentures: a prospective study. Int J Oral Maxillofac Implants. 2010 Jan-Feb;25(1):137-45. — View Citation

Cehreli MC, Uysal S, Akca K. Marginal bone level changes and prosthetic maintenance of mandibular overdentures supported by 2 implants: a 5-year randomized clinical trial. Clin Implant Dent Relat Res. 2010 Jun 1;12(2):114-21. doi: 10.1111/j.1708-8208.2008 — View Citation

Meijer HJ, Raghoebar GM, de Waal YC, Vissink A. Incidence of peri-implant mucositis and peri-implantitis in edentulous patients with an implant-retained mandibular overdenture during a 10-year follow-up period. J Clin Periodontol. 2014 Dec;41(12):1178-83. — View Citation

Parmar S, Karir N, Walmsley D, Patel U. Long and short term management of implant-supported mandibular overdentures. Dent Update. 2013 Dec;40(10):830-2, 834-5. — View Citation

Troeltzsch M, Troeltzsch V, Brodine AH, Frankenberger R, Messlinger K, Troeltzsch M. Clinical performance and peri-implant parameters of 132 implants supporting locator-retained overdentures: a case series of 33 patients. Int J Oral Maxillofac Implants. 2 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary probing depth in implants individuals who underwent the installation of dental implants for making full upper and lower overdentures in 2007 7 years Yes
Secondary gingival index (GI) individuals who underwent the installation of dental implants for making full upper and lower overdentures in 2007 7 years Yes
Secondary plaque index (PI) individuals who underwent the installation of dental implants for making full upper and lower overdentures in 2007 7 years Yes
See also
  Status Clinical Trial Phase
Completed NCT02904551 - Gingival Augmentation Around Implants During Maintenance N/A