Clinical trial NCT04769622: Influence of Environmental Factors on the Efficacy of Non-surgical Periodontal Treatment. A Pre-post Quasi-experimental Study
Official title: Influence of Environmental Factors on the Efficacy of Non-surgical Periodontal Treatment. A Pre-post Quasi-experimental Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Non Surgical Periodontal Treatment
Periodontitis
Periodontal Diseases
Keywords: periodontitis
non surgical periodontal treatment
Lead sponsor: University of Siena
Sponsor class: OTHER
First posted: 2021-02-24
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with untreated periodontitis coming to the Unit of Periodontics at the University of Siena and meeting the inclusion and exclusion criteria

Brief summary: Periodontitis is a biofilm-mediated chronic inflammatory disease which causes the destruction of the supporting tissues of the tooth. Risk factors for periodontitis include familiarity for periodontal diseases, diabetes, cardiovascular diseases, metabolic syndrome, obesity and stress. Some studies demonstrated how these risk factors negatively influence the patients' response to non-surgical periodontal treatment. The success of non-surgical periodontal therapy is defined through the treat-to-target concept (i.e. a maximum of 4 sites with Probing Pocket Depth \>5mm and presence of Bleeding on Probing); therefore, periodontal treatment is successful whenever this threshold is reached. Moreover, given the available data regarding the association between more severe forms of periodontitis and a lower frequency of physical activity, a worse sleep quality and more perceived stress, it is reasonable to hypothesize that these factors could influence the patients' response to non-surgical periodontal treatment. With regards to diet, despite many studies appraised the anti-inflammatory effect of the mediterranean diet, no study has ever related adherence to Mediterranean Diet to oral health status. The novelty that the present study would introduce is the evaluation of how environmental factors (i.e. diet, physical exercise, perceived stress) influence patients' response to non-surgical periodontal therapy.


Eligibility criteria: Inclusion Criteria:

* age between 18 and 70 years old;
* presence of untreated periodontitis (Papapanou at al. 2018);
* ability and willingness to give informed consent.

Exclusion Criteria:

* pregnancy or lactation;
* patients who underwent non-surgical periodontal therapy in the last 6 months;
* patients taking immunosuppressive drugs;
* inability or unwillingness to give informed consent.

Primary outcomes:
measure: Treat-to-target after treatment (yes/no)
timeFrame: outcome measured at reevaluation (3 months after the completion of non-surgical periodontal treatment)
Secondary outcomes:
measure: Influence of adherence to Mediterranean diet on the success of non-surgical periodontal treatment (treat-to-target)
timeFrame: outcome measured at reevaluation (3 months after the completion of non-surgical periodontal treatment)
measure: Influence of Sleep Quality on the success of non-surgical periodontal treatment (treat-to-target)
timeFrame: outcome measured at reevaluation (3 months after the completion of non-surgical periodontal treatment)
measure: Influence of Physical Activity on the success of non-surgical periodontal treatment (treat-to-target)
timeFrame: outcome measured at reevaluation (3 months after the completion of non-surgical periodontal treatment)
measure: Influence of Perceived Stress on the success of non-surgical periodontal treatment (treat-to-target)
timeFrame: outcome measured at reevaluation (3 months after the completion of non-surgical periodontal treatment)
Other outcomes:
Locations:
city: Siena
country: Italy
facility: AOUS
Study officials:
References: