Clinical trial NCT02662361: Evaluation of the Prevalence and Risk Factors for Patients With Peri-implant Disease：a Retrospective Study
Official title: The Prevalence and Risk Factors for Patients With Peri-implant Disease：a Retrospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Jaw, Edentulous, Partially
Keywords: peri-implant disease; risk factors; prevalence
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2016-01-25
Enrollment: 131
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients restored with implant-supported fixed partial dentures and single crowns at the Department of Prosthodontics, School of Stomatology of the Fourth Military Medical University between January 2011 to May 2014.

Brief summary: To investigate the patient-related risk factors for peri-implant disease in partially edentulous patients rehabilitated with implants supported crown or bridge so as to provide evidence for clinical prevention and control.

Detailed description: Objective: To investigate the patient-related risk factors for peri-implant disease in partially edentulous patients rehabilitated with implants supported crown or bridge so as to provide evidence for clinical prevention and control. Methods:A total of 131 patients will enroll in the study. Univariate and multivariate logistic regression analysis is used to determine the patient factors associated with peri-implant disease. The variables include age, gender, smoking and alcohol consumption, presence of diabetes, cardiovascular disease, osteoporosis, bruxism, bleeding upon brushing, reason for extraction, oral hygiene and periodontal status.

Eligibility criteria: Inclusion Criteria:

Patients implanted at least one implant and restored with implant-supported fixed partial dentures and single crowns.

The implant-supported fixed partial dentures and single crowns were in function at least one year.

Exclusion Criteria:

Jaw radiotherapy treatment before and after implanting. Patients who have bruxism, xerostomia or the adjacent teeth periapical periodontitis.

Patients who suffered with oral mucosa disease,or aggressive periodontitis or jaw defect.

Patients who suffered with mental and psychological disease will influence their oral health normal maintenance.

Primary outcomes:
measure: Survival of implants
timeFrame: at the first return visit（at least one year after restoration）
Secondary outcomes:
measure: Gingival Bleeding on Probing
timeFrame: at the first return visit（at least one year after restoration）
measure: Pocket depths
timeFrame: at the first return visit（at least one year after restoration）
measure: Marginal bone loss
timeFrame: at the first return visit（at least one year after restoration）
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Stomatological Hospital of Fourth Military Medical University
state: Shanxi
Study officials:
affiliation: IRB of Stomatological Hospital of FMMU,PLA
name: Yongjin Chen, 029-84776488
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ferreira SD, Silva GL, Cortelli JR, Costa JE, Costa FO. Prevalence and risk variables for peri-implant disease in Brazilian subjects. J Clin Periodontol. 2006 Dec;33(12):929-35. doi: 10.1111/j.1600-051X.2006.01001.x.