<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04439877</url>
  </required_header>
  <id_info>
    <org_study_id>PER-ECL-2017-08</org_study_id>
    <nct_id>NCT04439877</nct_id>
  </id_info>
  <brief_title>Exploring the Relationship Among Dental Caries, Nutritional Habits and Peri-implantitis</brief_title>
  <official_title>Exploring the Relationship Among Dental Caries, Nutritional Habits and Peri-implantitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitat Internacional de Catalunya</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universitat Internacional de Catalunya</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Aim: A study was made of the prevalence, co-occurrence and association among caries,&#xD;
      nutritional habits and peri-implant disease, with an analysis of the influence of other&#xD;
      patient and implant factors upon peri-implant disease.&#xD;
&#xD;
      Material and methods: The included subjects underwent a clinical examination and were asked&#xD;
      to complete a questionnaire. Demographic data and potential lifestyle/behavioral variables&#xD;
      were collected. Clinical and radiographic assessment allowed calculation of the decayed,&#xD;
      missing and filled teeth (DMFT) index and peri-implant diagnosis. Uni- and multivariate&#xD;
      logistic regression analyses were applied to identify predictors of peri-implant disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      2.1. Study design&#xD;
&#xD;
      The present cross-sectional study was conducted after approval from the local Ethics&#xD;
      Committee (Ref. PER-ECL-PER-2017-08) and in accordance with the ethical principles outlined&#xD;
      in the Declaration of Helsinki. It is reported according the Strengthening the Reporting of&#xD;
      Observational Studies Epidemiology (STROBE) statement recommendations (von Elm et al., 2009).&#xD;
      Selected subjects were informed about the aims of the research, and written consent was&#xD;
      obtained before starting the study.&#xD;
&#xD;
      2.2. Study population&#xD;
&#xD;
      Patients visiting the Postgraduate Periodontology Clinic of the Faculty of Dentistry of the&#xD;
      Universitat Internacional de Catalunya (Barcelona, Spain) from January 2018 to December 2019&#xD;
      were consecutively enrolled in the study by one of the researchers (JV), if they met the&#xD;
      criteria addressed later on in the form.&#xD;
&#xD;
      2.3. Data collection&#xD;
&#xD;
      Data collection comprised a patient interview and clinical and radiographic assessment.&#xD;
      Initially, a previously trained examiner (MP) interviewed the patients and collected the&#xD;
      following data:&#xD;
&#xD;
        -  Age (years).&#xD;
&#xD;
        -  Gender (female/male).&#xD;
&#xD;
        -  Smoking habit: smoker, non-smoker or ex-smoker. In the case of smokers, the total amount&#xD;
           of cigarettes per day was categorized as &lt; 10 or more than 10 cigarettes per day.&#xD;
&#xD;
        -  Systemic diseases: presence or absence.&#xD;
&#xD;
        -  Diabetes mellitus: presence or absence. In the case of diabetic patients, glycemic&#xD;
           control was assessed on the basis of a previous blood test.&#xD;
&#xD;
        -  Body mass index (BMI): recorded as weight (kg)/ height (m)2.&#xD;
&#xD;
        -  Dietary habits: assessed by the Mediterranean Diet Score (MDS) questionnaire&#xD;
           (Martínez-González et al., 2012) and classified as low adherence (score ≤ 5), medium&#xD;
           adherence (score 6-9) or high adherence (score ≥10).&#xD;
&#xD;
        -  Regular sugar consumption: yes or no. Sugar consumers were also asked about their level&#xD;
           of sugar intake (low, medium, high).&#xD;
&#xD;
        -  Nutrient or vitamin deficiencies: presence or absence.&#xD;
&#xD;
        -  Oral dryness: patient perception of dry mouth (presence or absence).&#xD;
&#xD;
        -  Educational level (EL): primary and secondary or professional and university.&#xD;
&#xD;
        -  Oral hygiene measures: frequency of teeth brushing and interproximal hygiene.&#xD;
&#xD;
        -  Supportive periodontal treatment (SPT): regular (≥ 2 times/year) or irregular (&lt; 2&#xD;
           times/year).&#xD;
&#xD;
        -  Cause of tooth loss: caries, mobility, caries and mobility, and trauma/fracture.&#xD;
&#xD;
      Any doubts coming from the questionnaire were solved by the examiner. A previously calibrated&#xD;
      examiner (LG) conducted the intraoral examination (with a Cohen inter-agreement kappa index &gt;&#xD;
      85%). The exploration was conducted to assess the following parameters:&#xD;
&#xD;
        -  Periodontal indexes: full mouth plaque score (FMPS) (O'Leary et al. 1972) and bleeding&#xD;
           score (FMBS) (Ainamo &amp; Bay 1975).&#xD;
&#xD;
        -  History of periodontitis: assessed radiographically by the presence or absence of bone&#xD;
           loss.&#xD;
&#xD;
        -  Number of decayed, missing and filled teeth (DMFT) assessed by visual inspection and&#xD;
           radiographic assessment following the ICDAS (Pitts &amp; Ekstrand, 2013). All tooth surfaces&#xD;
           were examined, but the observations were recorded per tooth.&#xD;
&#xD;
        -  Probing pocket depth (PPD) (in mm), bleeding on probing (BoP) (yes/no), suppuration&#xD;
           (SUP) (yes/no), keratinized mucosa (KM) (in mm) were all recorded at 6 sites per implant&#xD;
           using a PCP UNC 15 probe (Hu-Friedy ®).&#xD;
&#xD;
        -  Radiographic bone level (in mm) at mesial and distal to the implant site using the&#xD;
           parallel cone technique.&#xD;
&#xD;
        -  Implant position (anterior maxilla, anterior mandible, posterior maxilla, posterior&#xD;
           mandible).&#xD;
&#xD;
        -  Interproximal untreated caries or fillings adjacent to implants: yes/no. If these&#xD;
           conditions were present, their location was recorded (mesial, distal or both).&#xD;
&#xD;
      Patients presenting with caries or periodontal or peri-implant disease were referred to the&#xD;
      corresponding clinical department within the Universitat Internacional de Catalunya for&#xD;
      further evaluation and management.&#xD;
&#xD;
      2.4. Outcome measures&#xD;
&#xD;
      The main outcome measure of the study was the prevalence of dental caries and peri-implant&#xD;
      disease.&#xD;
&#xD;
      All other variables obtained from the questionnaire and clinical examination were regarded as&#xD;
      secondary outcome measures.&#xD;
&#xD;
      2.5. Sample size calculation&#xD;
&#xD;
      A logit regression model used to associate the outcome diagnosis at the patient level and&#xD;
      each exposure variable reached a statistical power of 82.5% in detecting odds ratio (OR) =&#xD;
      2.5 as being significant in the recruited sample (n= 169), assuming a confidence level of&#xD;
      95%. At the implant level, the power was 96.2% under the same previous conditions. Due to the&#xD;
      multi-level design, the power had to be corrected. In this regard, assuming a moderate&#xD;
      intra-subject correlation (ρ = 0.5), a power of 87.7% was estimated.&#xD;
&#xD;
      2.6. Statistical analysis&#xD;
&#xD;
      A descriptive analysis was carried out, with the calculation of absolute and relative&#xD;
      frequencies (categorical variables) and the mean and standard deviation (SD) (continuous&#xD;
      variables).&#xD;
&#xD;
      At patient level, simple binary logistic regression models were estimated to study the&#xD;
      association between the patient diagnosis (H versus M, and H versus PI) and each of the&#xD;
      exposure variables. At implant level, simple binary logistic regression models were estimated&#xD;
      using generalized estimating equations (GEEs). The models estimated odds ratio (OR) from the&#xD;
      Wald chi-squared statistic. The GEE approach addressed intra-subject dependency between&#xD;
      observations due to the multiplicity of implants per patient. Relevant exposure variables&#xD;
      (p&lt;0.10) were incorporated into a multiple logistic regression model at patient and implant&#xD;
      level to obtain adjusted ORs. The SPPS version 21.0 statistical package (SPSS Inc., Chicago,&#xD;
      IL, USA) was used throughout. The level of significance was 5% (α = 0.05).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2018</start_date>
  <completion_date type="Actual">March 5, 2020</completion_date>
  <primary_completion_date type="Actual">February 1, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Prevalence of dental caries and peri-implant disease</measure>
    <time_frame>Through the study completion, an average of 2 years</time_frame>
    <description>Expressed as percentages and absolute frequencies (% and n)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mediterranean Diet adherence</measure>
    <time_frame>Through the study completion, an average of 2 years</time_frame>
    <description>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 &gt;10)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sugar consumption</measure>
    <time_frame>Through the study completion, an average of 2 years</time_frame>
    <description>Patients sugar consumption assessed dichotomously (yes/no). Sugar consumers were also asked about their level of sugar intake (low, medium, high).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peri-implant parameters (Probing pocket depth, keratinised mucosa)</measure>
    <time_frame>Through the study completion, an average of 2 years</time_frame>
    <description>Expressed as millimetres (quantitative variables) measured at 6 sites per implant</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peri-implant parameters (Bleeding on probing, suppuration)</measure>
    <time_frame>Through the study completion, an average of 2 years</time_frame>
    <description>Assessed dichotomously (yes/no) at 6 sites per implant</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body Mass Index (BMI)</measure>
    <time_frame>Through the study completion, an average of 2 years</time_frame>
    <description>Recorded as weight (kg)/ height (m)2 and classified as underweight, normal weight, overweight or obesity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diabetes mellitus</measure>
    <time_frame>Through the study completion, an average of 2 years</time_frame>
    <description>presence or absence. In the case of diabetic patients, glycemic control was assessed on the basis of a previous blood test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nutrition or vitamin deficiency</measure>
    <time_frame>Through the study completion, an average of 2 years</time_frame>
    <description>Recorded as presence or absence</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oral dryness</measure>
    <time_frame>Through the study completion, an average of 2 years</time_frame>
    <description>Patient perception of dry mouth (presence or absence).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Educational level (EL)</measure>
    <time_frame>Through the study completion, an average of 2 years</time_frame>
    <description>primary and secondary or professional and university</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oral hygiene measures</measure>
    <time_frame>Through the study completion, an average of 2 years</time_frame>
    <description>Frequency of teeth brushing and interproximal hygiene.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Supportive periodontal treatment</measure>
    <time_frame>Through the study completion, an average of 2 years</time_frame>
    <description>Regular (≥ 2 times/year) or irregular (&lt; 2 times/year).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cause of tooth loss</measure>
    <time_frame>Through the study completion, an average of 2 years</time_frame>
    <description>Assessed as caries, mobility, caries and mobility, and trauma/fracture.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>History of periodontitis</measure>
    <time_frame>Through the study completion, an average of 2 years</time_frame>
    <description>Assessed radiographically by the presence or absence of bone loss.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Implant position</measure>
    <time_frame>Through the study completion, an average of 2 years</time_frame>
    <description>Assessed as anterior or posterior, maxilla or mandible</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Interproximal untreated caries or fillings adjacent to implants</measure>
    <time_frame>Through the study completion, an average of 2 years</time_frame>
    <description>Assessed as yes/no. If these conditions were present, their location was recorded (mesial, distal or both)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radiographic bone level</measure>
    <time_frame>Through the study completion, an average of 2 years</time_frame>
    <description>Assessed in milimmeters at mesial and distal aspects</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Age</measure>
    <time_frame>Through the study completion, an average of 2 years</time_frame>
    <description>Expressed as years</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gender</measure>
    <time_frame>Through the study completion, an average of 2 years</time_frame>
    <description>Expressed as male or female</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Smoking habit</measure>
    <time_frame>Through the study completion, an average of 2 years</time_frame>
    <description>Expressed as smoker, non-smoker or ex-smoker. In the case of smokers, the total amount of cigarettes per day was categorized as &lt; 10 or less or equal to 10 cigarettes per day.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Systemic diseases</measure>
    <time_frame>Through the study completion, an average of 2 years</time_frame>
    <description>Assessed as yes/no</description>
  </secondary_outcome>
  <enrollment type="Actual">169</enrollment>
  <condition>Peri-Implantitis</condition>
  <condition>Mucositis</condition>
  <condition>Caries,Dental</condition>
  <condition>Nutrition</condition>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Peri-implant disease diagnosis</intervention_name>
    <description>Diagnosis of peri-implant disease</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients older than 18 years old visiting the Postgraduate Periodontology Clinic of the&#xD;
        Faculty of Dentistry of the Universitat Internacional de Catalunya (Barcelona, Spain) from&#xD;
        January 2018 to December 2019 were consecutively enrolled for caries exploration and dental&#xD;
        implant condition assessment.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  Males or females ≥ 18 years of age.&#xD;
&#xD;
          -  One or more dental implants with an implant-supported fixed restoration.&#xD;
&#xD;
          -  A minimum of one year elapsed from implant-supported restoration delivery.&#xD;
&#xD;
          -  Partially edentulous patients with more than 20 teeth in the mouth.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inaccuracy in recording peri-implant parameters due to prosthesis design.&#xD;
&#xD;
          -  Implant cemented-retained prosthesis.&#xD;
&#xD;
          -  Patients previously treated for peri-implantitis.&#xD;
&#xD;
          -  Patients taking medications known to modify bone metabolism or with established&#xD;
             degenerative diseases of bone (hyperparathyroidism, osteoporosis).&#xD;
&#xD;
          -  Patients who had taken antibiotics, nonsteroidal antiinflammatory drugs or&#xD;
             corticosteroids for more than two weeks in the three months before the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jose Nart, Dr</last_name>
    <role>Study Director</role>
    <affiliation>Universitat Internacional de Catalunya</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Universitat Internacional de Catalunya</name>
      <address>
        <city>Barcelona</city>
        <state>Catalonia</state>
        <zip>08195</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <reference>
    <citation>Berglundh T, Armitage G, Araujo MG, Avila-Ortiz G, Blanco J, Camargo PM, Chen S, Cochran D, Derks J, Figuero E, Hammerle CHF, Heitz-Mayfield LJA, Huynh-Ba G, Iacono V, Koo KT, Lambert F, McCauley L, Quirynen M, Renvert S, Salvi GE, Schwarz F, Tarnow D, Tomasi C, Wang HL, Zitzmann N. Peri-implant diseases and conditions: Consensus report of workgroup 4 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. J Periodontol. 2018 Jun;89 Suppl 1:S313-S318. doi: 10.1002/JPER.17-0739.</citation>
    <PMID>29926955</PMID>
  </reference>
  <reference>
    <citation>Martinez-Gonzalez MA, Garcia-Arellano A, Toledo E, Salas-Salvado J, Buil-Cosiales P, Corella D, Covas MI, Schroder H, Aros F, Gomez-Gracia E, Fiol M, Ruiz-Gutierrez V, Lapetra J, Lamuela-Raventos RM, Serra-Majem L, Pinto X, Munoz MA, Warnberg J, Ros E, Estruch R; PREDIMED Study Investigators. A 14-item Mediterranean diet assessment tool and obesity indexes among high-risk subjects: the PREDIMED trial. PLoS One. 2012;7(8):e43134. doi: 10.1371/journal.pone.0043134. Epub 2012 Aug 14.</citation>
    <PMID>22905215</PMID>
  </reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 11, 2020</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 19, 2020</study_first_posted>
  <last_update_submitted>June 17, 2020</last_update_submitted>
  <last_update_submitted_qc>June 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universitat Internacional de Catalunya</investigator_affiliation>
    <investigator_full_name>Javi Vilarrasa</investigator_full_name>
    <investigator_title>Assistant Professor at the Department of Periodontology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mucositis</mesh_term>
    <mesh_term>Dental Caries</mesh_term>
    <mesh_term>Peri-Implantitis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04439877
org study id: PER-ECL-2017-08
nct id: NCT04439877
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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:

        -  Age (years).

        -  Gender (female/male).

        -  Smoking habit: smoker, non-smoker or ex-smoker. In the case of smokers, the total amount
           of cigarettes per day was categorized as < 10 or more than 10 cigarettes per day.

        -  Systemic diseases: presence or absence.

        -  Diabetes mellitus: presence or absence. In the case of diabetic patients, glycemic
           control was assessed on the basis of a previous blood test.

        -  Body mass index (BMI): recorded as weight (kg)/ height (m)2.

        -  Dietary habits: assessed by the Mediterranean Diet Score (MDS) questionnaire
           (Martínez-González et al., 2012) and classified as low adherence (score ≤ 5), medium
           adherence (score 6-9) or high adherence (score ≥10).

        -  Regular sugar consumption: yes or no. Sugar consumers were also asked about their level
           of sugar intake (low, medium, high).

        -  Nutrient or vitamin deficiencies: presence or absence.

        -  Oral dryness: patient perception of dry mouth (presence or absence).

        -  Educational level (EL): primary and secondary or professional and university.

        -  Oral hygiene measures: frequency of teeth brushing and interproximal hygiene.

        -  Supportive periodontal treatment (SPT): regular (≥ 2 times/year) or irregular (< 2
           times/year).

        -  Cause of tooth loss: caries, mobility, caries and mobility, and trauma/fracture.

      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:

        -  Periodontal indexes: full mouth plaque score (FMPS) (O'Leary et al. 1972) and bleeding
           score (FMBS) (Ainamo & Bay 1975).

        -  History of periodontitis: assessed radiographically by the presence or absence of bone
           loss.

        -  Number of decayed, missing and filled teeth (DMFT) assessed by visual inspection and
           radiographic assessment following the ICDAS (Pitts & Ekstrand, 2013). All tooth surfaces
           were examined, but the observations were recorded per tooth.

        -  Probing pocket depth (PPD) (in mm), bleeding on probing (BoP) (yes/no), suppuration
           (SUP) (yes/no), keratinized mucosa (KM) (in mm) were all recorded at 6 sites per implant
           using a PCP UNC 15 probe (Hu-Friedy ®).

        -  Radiographic bone level (in mm) at mesial and distal to the implant site using the
           parallel cone technique.

        -  Implant position (anterior maxilla, anterior mandible, posterior maxilla, posterior
           mandible).

        -  Interproximal untreated caries or fillings adjacent to implants: yes/no. If these
           conditions were present, their location was recorded (mesial, distal or both).

      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).
observational model: Cohort
time perspective: Cross-Sectional
measure: Prevalence of dental caries and peri-implant disease
time frame: Through the study completion, an average of 2 years
description: Expressed as percentages and absolute frequencies (% and n)
measure: Mediterranean Diet adherence
time frame: Through the study completion, an average of 2 years
description: 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)
measure: Sugar consumption
time frame: Through the study completion, an average of 2 years
description: Patients sugar consumption assessed dichotomously (yes/no). Sugar consumers were also asked about their level of sugar intake (low, medium, high).
measure: Peri-implant parameters (Probing pocket depth, keratinised mucosa)
time frame: Through the study completion, an average of 2 years
description: Expressed as millimetres (quantitative variables) measured at 6 sites per implant
measure: Peri-implant parameters (Bleeding on probing, suppuration)
time frame: Through the study completion, an average of 2 years
description: Assessed dichotomously (yes/no) at 6 sites per implant
measure: Body Mass Index (BMI)
time frame: Through the study completion, an average of 2 years
description: Recorded as weight (kg)/ height (m)2 and classified as underweight, normal weight, overweight or obesity.
measure: Diabetes mellitus
time frame: Through the study completion, an average of 2 years
description: presence or absence. In the case of diabetic patients, glycemic control was assessed on the basis of a previous blood test.
measure: Nutrition or vitamin deficiency
time frame: Through the study completion, an average of 2 years
description: Recorded as presence or absence
measure: Oral dryness
time frame: Through the study completion, an average of 2 years
description: Patient perception of dry mouth (presence or absence).
measure: Educational level (EL)
time frame: Through the study completion, an average of 2 years
description: primary and secondary or professional and university
measure: Oral hygiene measures
time frame: Through the study completion, an average of 2 years
description: Frequency of teeth brushing and interproximal hygiene.
measure: Supportive periodontal treatment
time frame: Through the study completion, an average of 2 years
description: Regular (≥ 2 times/year) or irregular (< 2 times/year).
measure: Cause of tooth loss
time frame: Through the study completion, an average of 2 years
description: Assessed as caries, mobility, caries and mobility, and trauma/fracture.
measure: History of periodontitis
time frame: Through the study completion, an average of 2 years
description: Assessed radiographically by the presence or absence of bone loss.
measure: Implant position
time frame: Through the study completion, an average of 2 years
description: Assessed as anterior or posterior, maxilla or mandible
measure: Interproximal untreated caries or fillings adjacent to implants
time frame: Through the study completion, an average of 2 years
description: Assessed as yes/no. If these conditions were present, their location was recorded (mesial, distal or both)
measure: Radiographic bone level
time frame: Through the study completion, an average of 2 years
description: Assessed in milimmeters at mesial and distal aspects
measure: Age
time frame: Through the study completion, an average of 2 years
description: Expressed as years
measure: Gender
time frame: Through the study completion, an average of 2 years
description: Expressed as male or female
measure: Smoking habit
time frame: Through the study completion, an average of 2 years
description: 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.
measure: Systemic diseases
time frame: Through the study completion, an average of 2 years
description: Assessed as yes/no
intervention type: Behavioral
intervention name: Peri-implant disease diagnosis
description: Diagnosis of peri-implant disease
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jose Nart, Dr
role: Study Director
affiliation: Universitat Internacional de Catalunya
facility: 
country: Spain
citation: Berglundh T, Armitage G, Araujo MG, Avila-Ortiz G, Blanco J, Camargo PM, Chen S, Cochran D, Derks J, Figuero E, Hammerle CHF, Heitz-Mayfield LJA, Huynh-Ba G, Iacono V, Koo KT, Lambert F, McCauley L, Quirynen M, Renvert S, Salvi GE, Schwarz F, Tarnow D, Tomasi C, Wang HL, Zitzmann N. Peri-implant diseases and conditions: Consensus report of workgroup 4 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. J Periodontol. 2018 Jun;89 Suppl 1:S313-S318. doi: 10.1002/JPER.17-0739.
PMID: 29926955
citation: Martinez-Gonzalez MA, Garcia-Arellano A, Toledo E, Salas-Salvado J, Buil-Cosiales P, Corella D, Covas MI, Schroder H, Aros F, Gomez-Gracia E, Fiol M, Ruiz-Gutierrez V, Lapetra J, Lamuela-Raventos RM, Serra-Majem L, Pinto X, Munoz MA, Warnberg J, Ros E, Estruch R; PREDIMED Study Investigators. A 14-item Mediterranean diet assessment tool and obesity indexes among high-risk subjects: the PREDIMED trial. PLoS One. 2012;7(8):e43134. doi: 10.1371/journal.pone.0043134. Epub 2012 Aug 14.
PMID: 22905215
responsible party type: Principal Investigator
investigator affiliation: Universitat Internacional de Catalunya
investigator full name: Javi Vilarrasa
investigator title: Assistant Professor at the Department of Periodontology
mesh term: Mucositis
mesh term: Dental Caries
mesh term: Peri-Implantitis
sharing ipd: Undecided