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Clinical Trials/NCT04769622
NCT04769622
Unknown
Not Applicable

Influence of Environmental Factors on the Efficacy of Non-surgical Periodontal Treatment. A Pre-post Quasi-experimental Study

University of Siena1 site in 1 country125 target enrollmentFebruary 16, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Non Surgical Periodontal Treatment
Sponsor
University of Siena
Enrollment
125
Locations
1
Primary Endpoint
Treat-to-target after treatment (yes/no)
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 16, 2021
End Date
November 25, 2021
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Nicola Discepoli

Researcher

University of Siena

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.

Outcomes

Primary Outcomes

Treat-to-target after treatment (yes/no)

Time Frame: outcome measured at reevaluation (3 months after the completion of non-surgical periodontal treatment)

Binary outcome defining the success of non-surgical periodontal treatment. The treat-to-target is reached whenever patients at reevaluation have a maximum of 4 sites with Probing Pocket Depth (PPD) \>5mm and presence of Bleeding on Probing (BoP)

Secondary Outcomes

  • Influence of Sleep Quality on the success of non-surgical periodontal treatment (treat-to-target)(outcome measured at reevaluation (3 months after the completion of non-surgical periodontal treatment))
  • Influence of Physical Activity on the success of non-surgical periodontal treatment (treat-to-target)(outcome measured at reevaluation (3 months after the completion of non-surgical periodontal treatment))
  • Influence of Perceived Stress on the success of non-surgical periodontal treatment (treat-to-target)(outcome measured at reevaluation (3 months after the completion of non-surgical periodontal treatment))
  • Influence of adherence to Mediterranean diet on the success of non-surgical periodontal treatment (treat-to-target)(outcome measured at reevaluation (3 months after the completion of non-surgical periodontal treatment))

Study Sites (1)

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