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

Peri-Implantitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04439877
• Other study ID #: PER-ECL-2017-08
• Status: Completed
• Start date: February 1, 2018
• Est. completion date: March 5, 2020

Study information

• Verified date: June 2020
• Source: Universitat Internacional de Catalunya
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 169
• Est. completion date: March 5, 2020
• Est. primary completion date: February 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Caries,Dental
• Dental Caries
• Mucositis
• Nutrition
• Peri-Implantitis

Intervention

Behavioral:
• Peri-implant disease diagnosis
Diagnosis of peri-implant disease

Locations

Country	Name	City	State
Spain	Universitat Internacional de Catalunya	Barcelona	Catalonia

Sponsors (1)

Lead Sponsor	Collaborator
Universitat Internacional de Catalunya

Country where clinical trial is conducted

Spain, 

References & Publications (2)

Berglundh T, Armitage G, Araujo MG, Avila-Ortiz G, Blanco J, Camargo PM, Chen S, Cochran D, Derks J, Figuero E, Hämmerle 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. — View Citation

Martínez-González MA, García-Arellano A, Toledo E, Salas-Salvadó J, Buil-Cosiales P, Corella D, Covas MI, Schröder H, Arós F, Gómez-Gracia E, Fiol M, Ruiz-Gutiérrez V, Lapetra J, Lamuela-Raventos RM, Serra-Majem L, Pintó X, Muñoz MA, Wärnberg 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. Epub 2012 Aug 14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of dental caries and peri-implant disease	Expressed as percentages and absolute frequencies (% and n)	Through the study completion, an average of 2 years
Secondary	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)	Through the study completion, an average of 2 years
Secondary	Sugar consumption	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
Secondary	Peri-implant parameters (Probing pocket depth, keratinised mucosa)	Expressed as millimetres (quantitative variables) measured at 6 sites per implant	Through the study completion, an average of 2 years
Secondary	Peri-implant parameters (Bleeding on probing, suppuration)	Assessed dichotomously (yes/no) at 6 sites per implant	Through the study completion, an average of 2 years
Secondary	Body Mass Index (BMI)	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
Secondary	Diabetes mellitus	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
Secondary	Nutrition or vitamin deficiency	Recorded as presence or absence	Through the study completion, an average of 2 years
Secondary	Oral dryness	Patient perception of dry mouth (presence or absence).	Through the study completion, an average of 2 years
Secondary	Educational level (EL)	primary and secondary or professional and university	Through the study completion, an average of 2 years
Secondary	Oral hygiene measures	Frequency of teeth brushing and interproximal hygiene.	Through the study completion, an average of 2 years
Secondary	Supportive periodontal treatment	Regular (= 2 times/year) or irregular (< 2 times/year).	Through the study completion, an average of 2 years
Secondary	Cause of tooth loss	Assessed as caries, mobility, caries and mobility, and trauma/fracture.	Through the study completion, an average of 2 years
Secondary	History of periodontitis	Assessed radiographically by the presence or absence of bone loss.	Through the study completion, an average of 2 years
Secondary	Implant position	Assessed as anterior or posterior, maxilla or mandible	Through the study completion, an average of 2 years
Secondary	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)	Through the study completion, an average of 2 years
Secondary	Radiographic bone level	Assessed in milimmeters at mesial and distal aspects	Through the study completion, an average of 2 years
Secondary	Age	Expressed as years	Through the study completion, an average of 2 years
Secondary	Gender	Expressed as male or female	Through the study completion, an average of 2 years
Secondary	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.	Through the study completion, an average of 2 years
Secondary	Systemic diseases	Assessed as yes/no	Through the study completion, an average of 2 years