Exploring the Relationship Among Dental Caries, Nutritional Habits and Peri-implantitis

June 17, 2020 updated by: Javi Vilarrasa, Universitat Internacional de Catalunya

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.

Study Overview

Detailed Description

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).

Study Type

Observational

Enrollment (Actual)

169

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Catalonia
      • Barcelona, Catalonia, Spain, 08195
        • Universitat Internacional de Catalunya

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All patients older than 18 years old 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 for caries exploration and dental implant condition assessment.

Description

Inclusion Criteria

  • Males or females ≥ 18 years of age.
  • One or more dental implants with an implant-supported fixed restoration.
  • A minimum of one year elapsed from implant-supported restoration delivery.
  • Partially edentulous patients with more than 20 teeth in the mouth.

Exclusion Criteria:

  • Inaccuracy in recording peri-implant parameters due to prosthesis design.
  • Implant cemented-retained prosthesis.
  • Patients previously treated for peri-implantitis.
  • Patients taking medications known to modify bone metabolism or with established degenerative diseases of bone (hyperparathyroidism, osteoporosis).
  • Patients who had taken antibiotics, nonsteroidal antiinflammatory drugs or corticosteroids for more than two weeks in the three months before the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of dental caries and peri-implant disease
Time Frame: Through the study completion, an average of 2 years
Expressed as percentages and absolute frequencies (% and n)
Through the study completion, an average of 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mediterranean Diet adherence
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)
Through the study completion, an average of 2 years
Sugar consumption
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).
Through the study completion, an average of 2 years
Peri-implant parameters (Probing pocket depth, keratinised mucosa)
Time Frame: Through the study completion, an average of 2 years
Expressed as millimetres (quantitative variables) measured at 6 sites per implant
Through the study completion, an average of 2 years
Peri-implant parameters (Bleeding on probing, suppuration)
Time Frame: Through the study completion, an average of 2 years
Assessed dichotomously (yes/no) at 6 sites per implant
Through the study completion, an average of 2 years
Body Mass Index (BMI)
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.
Through the study completion, an average of 2 years
Diabetes mellitus
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.
Through the study completion, an average of 2 years
Nutrition or vitamin deficiency
Time Frame: Through the study completion, an average of 2 years
Recorded as presence or absence
Through the study completion, an average of 2 years
Oral dryness
Time Frame: Through the study completion, an average of 2 years
Patient perception of dry mouth (presence or absence).
Through the study completion, an average of 2 years
Educational level (EL)
Time Frame: Through the study completion, an average of 2 years
primary and secondary or professional and university
Through the study completion, an average of 2 years
Oral hygiene measures
Time Frame: Through the study completion, an average of 2 years
Frequency of teeth brushing and interproximal hygiene.
Through the study completion, an average of 2 years
Supportive periodontal treatment
Time Frame: Through the study completion, an average of 2 years
Regular (≥ 2 times/year) or irregular (< 2 times/year).
Through the study completion, an average of 2 years
Cause of tooth loss
Time Frame: Through the study completion, an average of 2 years
Assessed as caries, mobility, caries and mobility, and trauma/fracture.
Through the study completion, an average of 2 years
History of periodontitis
Time Frame: Through the study completion, an average of 2 years
Assessed radiographically by the presence or absence of bone loss.
Through the study completion, an average of 2 years
Implant position
Time Frame: Through the study completion, an average of 2 years
Assessed as anterior or posterior, maxilla or mandible
Through the study completion, an average of 2 years
Interproximal untreated caries or fillings adjacent to implants
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)
Through the study completion, an average of 2 years
Radiographic bone level
Time Frame: Through the study completion, an average of 2 years
Assessed in milimmeters at mesial and distal aspects
Through the study completion, an average of 2 years
Age
Time Frame: Through the study completion, an average of 2 years
Expressed as years
Through the study completion, an average of 2 years
Gender
Time Frame: Through the study completion, an average of 2 years
Expressed as male or female
Through the study completion, an average of 2 years
Smoking habit
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.
Through the study completion, an average of 2 years
Systemic diseases
Time Frame: Through the study completion, an average of 2 years
Assessed as yes/no
Through the study completion, an average of 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Jose Nart, Dr, Universitat Internacional de Catalunya

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2018

Primary Completion (Actual)

February 1, 2018

Study Completion (Actual)

March 5, 2020

Study Registration Dates

First Submitted

June 11, 2020

First Submitted That Met QC Criteria

June 17, 2020

First Posted (Actual)

June 19, 2020

Study Record Updates

Last Update Posted (Actual)

June 19, 2020

Last Update Submitted That Met QC Criteria

June 17, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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