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

NCT04236622 | Completed DMC

• 1 other identifier: SantosMU6
• Study Type: observational
• Target: 182
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Implant Failed

Keywords

dental implants; periodontal index; peri-implantitis

Outcome Measures

Primary Outcomes (1)

• Probing depth

  lower probing depth in patients who underwent annual maintenance

  10 years

Secondary Outcomes (1)

• Plaque control

  10 years

Study Arms (2)

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).

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).

Other: Periodontal clinical exam

Interventions

Periodontal clinical exam OTHER

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.

Also known as: Radiographic exam

Health; Peri-implantitis

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Individuals who need to use or suspend systemic medication to perform the proposed clinical exams will be excluded from the study.

Sponsors & Collaborators

• Universidade Metropolitana de Santos: lead

Study Sites (1)

University of Santo Amaro - UNISA/SP

São Paulo, São Paulo, Brazil

Location

Related Publications (3)

• 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.

  PMID: 25370914 RESULT

• 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.

  PMID: 20586784 RESULT

• 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.

  PMID: 24004092 RESULT

MeSH Terms

Conditions

Peri-Implantitis

Interventions

X-Rays

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing

Study Officials

• CAIO VINICIUS G ROMAN TORRES, PhD

  University of South Australia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 17, 2020
• First Posted: January 22, 2020
• Study Start: January 1, 2016
• Primary Completion: February 10, 2016
• Study Completion: October 30, 2019
• Last Updated: January 27, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)