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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
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).
- Conditions
- Peri-Implantitis, Mucositis, Caries,Dental, Nutrition
- 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.
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)
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
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
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
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
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
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
Nutrition or vitamin deficiency
Recorded as presence or absence
Measured: Through the study completion, an average of 2 years
Oral dryness
Patient perception of dry mouth (presence or absence).
Measured: Through the study completion, an average of 2 years
Educational level (EL)
primary and secondary or professional and university
Measured: Through the study completion, an average of 2 years
Oral hygiene measures
Frequency of teeth brushing and interproximal hygiene.
Measured: Through the study completion, an average of 2 years
Supportive periodontal treatment
Regular (≥ 2 times/year) or irregular (< 2 times/year).
Measured: Through the study completion, an average of 2 years
Cause of tooth loss
Assessed as caries, mobility, caries and mobility, and trauma/fracture.
Measured: Through the study completion, an average of 2 years
History of periodontitis
Assessed radiographically by the presence or absence of bone loss.
Measured: Through the study completion, an average of 2 years
Implant position
Assessed as anterior or posterior, maxilla or mandible
Measured: Through the study completion, an average of 2 years
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
Radiographic bone level
Assessed in milimmeters at mesial and distal aspects
Measured: Through the study completion, an average of 2 years
Age
Expressed as years
Measured: Through the study completion, an average of 2 years
Gender
Expressed as male or female
Measured: Through the study completion, an average of 2 years
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
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.
- First posted19 Jun 2020
- Study start1 Feb 2018
- Primary completion1 Feb 2018
- Study completion5 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Peri-ImplantitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Universitat Internacional de Catalunya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Javi Vilarrasa, Universitat Internacional de Catalunya
- Investigators
- Jose Nart, Dr, Study director, Universitat Internacional de Catalunya
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 29926955Martinez-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
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Relationship Among Dental Caries, Nutritional Habits and Peri-implantitis
- ClinicalTrials.gov ID
- NCT04439877
- Acronym / sponsor ID
- PER-ECL-2017-08
- Conditions
- Peri-Implantitis, Mucositis, Caries,Dental, Nutrition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 169 participants (actual)
- Lead sponsor
- Universitat Internacional de CatalunyaUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 1 Feb 2018 (actual)
- Study completion
- 5 Mar 2020 (actual)
- First posted
- 19 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peri-implant disease diagnosisDiagnosis of peri-implant disease | Behavioural | – |
Primary outcome
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)
20 secondary outcomes
Mediterranean Diet adherence
Time frame: Through the study completion, an average of 2 years
Sugar consumption
Time frame: 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
Peri-implant parameters (Bleeding on probing, suppuration)
Time frame: Through the study completion, an average of 2 years
Body Mass Index (BMI)
Time frame: Through the study completion, an average of 2 years
Diabetes mellitus
Time frame: Through the study completion, an average of 2 years
Nutrition or vitamin deficiency
Time frame: Through the study completion, an average of 2 years
Oral dryness
Time frame: Through the study completion, an average of 2 years
Educational level (EL)
Time frame: Through the study completion, an average of 2 years
Oral hygiene measures
Time frame: Through the study completion, an average of 2 years
Supportive periodontal treatment
Time frame: Through the study completion, an average of 2 years
Cause of tooth loss
Time frame: Through the study completion, an average of 2 years
History of periodontitis
Time frame: Through the study completion, an average of 2 years
Implant position
Time frame: 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
Radiographic bone level
Time frame: Through the study completion, an average of 2 years
Age
Time frame: Through the study completion, an average of 2 years
Gender
Time frame: Through the study completion, an average of 2 years
Smoking habit
Time frame: Through the study completion, an average of 2 years
Systemic diseases
Time frame: Through the study completion, an average of 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2020.
- Background: PubMed 29926955Berglundh 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.
- Background: PubMed 22905215Martinez-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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose Nart, Dr study director
Universitat Internacional de Catalunya
1 site in 1 country: see every site and its status.
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.