NCT02511977

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 5, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 30, 2015

Completed
Last Updated

July 30, 2015

Status Verified

July 1, 2015

Enrollment Period

7 months

First QC Date

June 5, 2015

Last Update Submit

July 27, 2015

Conditions

Keywords

Dental ProsthesisImplant-Supported

Outcome Measures

Primary Outcomes (1)

  • probing depth in implants

    individuals who underwent the installation of dental implants for making full upper and lower overdentures in 2007

    7 years

Secondary Outcomes (2)

  • gingival index (GI)

    7 years

  • plaque index (PI)

    7 years

Study Arms (2)

overdenture with annual maintenance

Rehabilitation should be: overdenture with at least 2 implants placed in the mandible and 3 implants in the maxilla per person. They were divided into two groups: Group I: Annual maintenance for the past seven years

Other: peri-implant examination

overdenture whitout annual maintenance

Group II: 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.

Other: peri-implant examination

Interventions

The prostheses were removed and all implants were evaluated: probing depth, plaque index and bleeding index.

overdenture whitout annual maintenanceoverdenture with annual maintenance

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Initially, 80 individuals who underwent the installation of dental implants for making overdentures in the Department of Implant Dentistry, Faculty of Dentistry, University of Santo Amaro, São Paulo, Brazil, in 2007,were evaluated.According to the inclusion and exclusion criteria, the final sample had 64 individuals of both genders, between 40 and 75 years old

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Santo Amaro - UNISA/SP

São Paulo, São Paulo, Brazil

Location

Related Publications (5)

  • 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. doi: 10.1111/jcpe.12311. Epub 2014 Nov 1.

  • 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. doi: 10.12968/denu.2013.40.10.830.

  • 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. 2013 Jul-Aug;28(4):1132-9. doi: 10.11607/jomi.3009.

  • 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.

  • 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.1708-8208.2008.00143.x. Epub 2009 Feb 13.

Study Officials

  • Caio VG Roman-Torres, PhD

    University of South Australia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

June 5, 2015

First Posted

July 30, 2015

Study Start

April 1, 2013

Primary Completion

November 1, 2013

Study Completion

February 1, 2015

Last Updated

July 30, 2015

Record last verified: 2015-07

Locations