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Peri-ImplantitisNCT04439877

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

An observational study of Peri-Implantitis and Mucositis, run by Universitat Internacional de Catalunya at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Peri-Implantitis, Mucositis, Caries,Dental
What is being tested?
Peri-implant disease diagnosis
How many people
169 participants
Where
1 siteSpain
Study dates
1 Feb 2018to 5 Mar 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • Universitat Internacional de Catalunya

    Barcelona, Catalonia, 08195

Other trials in Spain

About this study

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.

Read the 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).

Being tested
Peri-implant disease diagnosis
Medical subject headings
Peri-Implantitis, Mucositis, Dental Caries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Peri-implant disease diagnosisBehavioural

    Diagnosis of peri-implant disease

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Prevalence of dental caries and peri-implant disease

    Expressed as percentages and absolute frequencies (% and n)

    Measured: Through the study completion, an average of 2 years

Secondary outcomes (20)
  1. Mediterranean Diet adherence

    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)

    Measured: Through the study completion, an average of 2 years

  2. Sugar consumption

    Patients sugar consumption assessed dichotomously (yes/no). Sugar consumers were also asked about their level of sugar intake (low, medium, high).

    Measured: Through the study completion, an average of 2 years

  3. Peri-implant parameters (Probing pocket depth, keratinised mucosa)

    Expressed as millimetres (quantitative variables) measured at 6 sites per implant

    Measured: Through the study completion, an average of 2 years

  4. Peri-implant parameters (Bleeding on probing, suppuration)

    Assessed dichotomously (yes/no) at 6 sites per implant

    Measured: Through the study completion, an average of 2 years

  5. Body Mass Index (BMI)

    Recorded as weight (kg)/ height (m)2 and classified as underweight, normal weight, overweight or obesity.

    Measured: Through the study completion, an average of 2 years

  6. Diabetes mellitus

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

    Measured: Through the study completion, an average of 2 years

  7. Nutrition or vitamin deficiency

    Recorded as presence or absence

    Measured: Through the study completion, an average of 2 years

  8. Oral dryness

    Patient perception of dry mouth (presence or absence).

    Measured: Through the study completion, an average of 2 years

  9. Educational level (EL)

    primary and secondary or professional and university

    Measured: Through the study completion, an average of 2 years

  10. Oral hygiene measures

    Frequency of teeth brushing and interproximal hygiene.

    Measured: Through the study completion, an average of 2 years

  11. Supportive periodontal treatment

    Regular (≥ 2 times/year) or irregular (< 2 times/year).

    Measured: Through the study completion, an average of 2 years

  12. Cause of tooth loss

    Assessed as caries, mobility, caries and mobility, and trauma/fracture.

    Measured: Through the study completion, an average of 2 years

  13. History of periodontitis

    Assessed radiographically by the presence or absence of bone loss.

    Measured: Through the study completion, an average of 2 years

  14. Implant position

    Assessed as anterior or posterior, maxilla or mandible

    Measured: Through the study completion, an average of 2 years

  15. Interproximal untreated caries or fillings adjacent to implants

    Assessed as yes/no. If these conditions were present, their location was recorded (mesial, distal or both)

    Measured: Through the study completion, an average of 2 years

  16. Radiographic bone level

    Assessed in milimmeters at mesial and distal aspects

    Measured: Through the study completion, an average of 2 years

  17. Age

    Expressed as years

    Measured: Through the study completion, an average of 2 years

  18. Gender

    Expressed as male or female

    Measured: Through the study completion, an average of 2 years

  19. Smoking habit

    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.

    Measured: Through the study completion, an average of 2 years

  20. Systemic diseases

    Assessed as yes/no

    Measured: Through the study completion, an average of 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jun 2020
  2. Study start1 Feb 2018
  3. Primary completion1 Feb 2018
  4. Study completion5 Mar 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
169 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04439877
Sponsor's protocol ID
PER-ECL-2017-08
Status last verified
Jun 2020
First submitted
11 Jun 2020
Last updated
19 Jun 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 29926955
  • 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.

    PubMed 22905215

Questions about this trial

What is this clinical trial studying?

An observational study of Peri-Implantitis and Mucositis, run by Universitat Internacional de Catalunya at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prevalence of dental caries and peri-implant disease (time frame: Through the study completion, an average of 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04439877, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2020.

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