Universitat Internacional de Catalunya
Barcelona, Catalonia, 08195, Spain
NCT Number: NCT04439877
Aim: A study was made of the prevalence, co-occurrence and association among caries, nutritional habits and peri-implant disease, with an analysis of the influence of other patient and implant factors upon peri-implant disease.
Material and methods: The included subjects underwent a clinical examination and were asked to complete a questionnaire. Demographic data and potential lifestyle/behavioral variables were collected. Clinical and radiographic assessment allowed calculation of the decayed, missing and filled teeth (DMFT) index and peri-implant diagnosis. Uni- and multivariate logistic regression analyses were applied to identify predictors of peri-implant disease.
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Notify Me18 year and older
All sexes
Observational
Barcelona, Catalonia, 08195, Spain
2.1. Study design
The present cross-sectional study was conducted after approval from the local Ethics Committee (Ref. PER-ECL-PER-2017-08) and in accordance with the ethical principles outlined in the Declaration of Helsinki. It is reported according the Strengthening the Reporting of Observational Studies Epidemiology (STROBE) statement recommendations (von Elm et al., 2009). Selected subjects were informed about the aims of the research, and written consent was obtained before starting the study.
2.2. Study population
Patients visiting the Postgraduate Periodontology Clinic of the Faculty of Dentistry of the Universitat Internacional de Catalunya (Barcelona, Spain) from January 2018 to December 2019 were consecutively enrolled in the study by one of the researchers (JV), if they met the criteria addressed later on in the form.
2.3. Data collection
Data collection comprised a patient interview and clinical and radiographic assessment. Initially, a previously trained examiner (MP) interviewed the patients and collected the following data:
Any doubts coming from the questionnaire were solved by the examiner. A previously calibrated examiner (LG) conducted the intraoral examination (with a Cohen inter-agreement kappa index > 85%). The exploration was conducted to assess the following parameters:
Patients presenting with caries or periodontal or peri-implant disease were referred to the corresponding clinical department within the Universitat Internacional de Catalunya for further evaluation and management.
2.4. Outcome measures
The main outcome measure of the study was the prevalence of dental caries and peri-implant disease.
All other variables obtained from the questionnaire and clinical examination were regarded as secondary outcome measures.
2.5. Sample size calculation
A logit regression model used to associate the outcome diagnosis at the patient level and each exposure variable reached a statistical power of 82.5% in detecting odds ratio (OR) = 2.5 as being significant in the recruited sample (n= 169), assuming a confidence level of 95%. At the implant level, the power was 96.2% under the same previous conditions. Due to the multi-level design, the power had to be corrected. In this regard, assuming a moderate intra-subject correlation (ρ = 0.5), a power of 87.7% was estimated.
2.6. Statistical analysis
A descriptive analysis was carried out, with the calculation of absolute and relative frequencies (categorical variables) and the mean and standard deviation (SD) (continuous variables).
At patient level, simple binary logistic regression models were estimated to study the association between the patient diagnosis (H versus M, and H versus PI) and each of the exposure variables. At implant level, simple binary logistic regression models were estimated using generalized estimating equations (GEEs). The models estimated odds ratio (OR) from the Wald chi-squared statistic. The GEE approach addressed intra-subject dependency between observations due to the multiplicity of implants per patient. Relevant exposure variables (p<0.10) were incorporated into a multiple logistic regression model at patient and implant level to obtain adjusted ORs. The SPPS version 21.0 statistical package (SPSS Inc., Chicago, IL, USA) was used throughout. The level of significance was 5% (α = 0.05).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Diagnosis of peri-implant disease
Time frame: Through the study completion, an average of 2 years
Expressed as percentages and absolute frequencies (% and n)
Time frame: Through the study completion, an average of 2 years
This outcome was assessed by means of a questionnaire and a score. The scale score were categorised as low adherence (more or equal to 5), medium adherence (more than 5 and less or equal to 9) and high adherence (higher than >10)
Time frame: Through the study completion, an average of 2 years
Patients sugar consumption assessed dichotomously (yes/no). Sugar consumers were also asked about their level of sugar intake (low, medium, high).
Time frame: Through the study completion, an average of 2 years
Expressed as millimetres (quantitative variables) measured at 6 sites per implant
Time frame: Through the study completion, an average of 2 years
Assessed dichotomously (yes/no) at 6 sites per implant
Time frame: Through the study completion, an average of 2 years
Recorded as weight (kg)/ height (m)2 and classified as underweight, normal weight, overweight or obesity.
Time frame: Through the study completion, an average of 2 years
presence or absence. In the case of diabetic patients, glycemic control was assessed on the basis of a previous blood test.
Time frame: Through the study completion, an average of 2 years
Recorded as presence or absence
Time frame: Through the study completion, an average of 2 years
Patient perception of dry mouth (presence or absence).
Time frame: Through the study completion, an average of 2 years
primary and secondary or professional and university
Time frame: Through the study completion, an average of 2 years
Frequency of teeth brushing and interproximal hygiene.
Time frame: Through the study completion, an average of 2 years
Regular (≥ 2 times/year) or irregular (< 2 times/year).
Time frame: Through the study completion, an average of 2 years
Assessed as caries, mobility, caries and mobility, and trauma/fracture.
Time frame: Through the study completion, an average of 2 years
Assessed radiographically by the presence or absence of bone loss.
Time frame: Through the study completion, an average of 2 years
Assessed as anterior or posterior, maxilla or mandible
Time frame: Through the study completion, an average of 2 years
Assessed as yes/no. If these conditions were present, their location was recorded (mesial, distal or both)
Time frame: Through the study completion, an average of 2 years
Assessed in milimmeters at mesial and distal aspects
Time frame: Through the study completion, an average of 2 years
Expressed as years
Time frame: Through the study completion, an average of 2 years
Expressed as male or female
Time frame: Through the study completion, an average of 2 years
Expressed as smoker, non-smoker or ex-smoker. In the case of smokers, the total amount of cigarettes per day was categorized as < 10 or less or equal to 10 cigarettes per day.
Time frame: Through the study completion, an average of 2 years
Assessed as yes/no
Universitat Internacional de Catalunya
Other
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