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

February 23, 2021 updated by: Nicola Discepoli, University of Siena
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

125

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patients affected by untreated Periodontitis
patients coming to the Unit of Periodontics at the University of Siena will be screened for the inclusion in the study. All patients eligible for the inclusion in the study will undergo non-surgical periodontal treatment and will be administered a questionnaire about lifestyles (adherence to mediterranean diet, sleep quality, physical activity, perceived stress). Patients will be then reevaluated at 3 months after the completion on non-surgical periodontal therapy.
Procedure: Non-surgical periodontal treatment
all included patients will be subjected to non-surgical periodontal therapy
Other: Questionnaires

All patients will be asked to complete a set of questionnaires regarding:

  • adherence to Mediterranean Diet;
  • sleep quality;
  • physical activity;
  • perceived stress.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Influence of adherence to Mediterranean diet on the success of non-surgical periodontal treatment (treat-to-target)
Time Frame: outcome measured at reevaluation (3 months after the completion of non-surgical periodontal treatment)
results obtained from the questionnaire about adherence to Mediterranean Diet (Gnagnarella et al. 2018) will be placed in a logistic regression model, whose aim will be to investigate the influence of adherence to Mediterranean diet (predictors) on the success of non surgical periodontal treatment (treat to target; dependent variable). Adherence to Mediterranean diet is evaluated on a scale between 0 and 9; the higher the score, the higher the adherence to Mediterranean Diet.
outcome measured at reevaluation (3 months after the completion of non-surgical periodontal treatment)
Influence of Sleep Quality on the success of non-surgical periodontal treatment (treat-to-target)
Time Frame: outcome measured at reevaluation (3 months after the completion of non-surgical periodontal treatment)
results obtained from the questionnaire about Sleep Quality (Pittsburgh Sleep Quality Index) will be placed in a logistic regression model, whose aim will be to investigate the influence of sleep quality (predictor) on the success of non surgical periodontal treatment (treat to target; dependent variable). Sleep quality is evaluated on a scale between 0 and 21; the higher the score, the poorer the Sleep Quality.
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)
Time Frame: outcome measured at reevaluation (3 months after the completion of non-surgical periodontal treatment)
results obtained from the questionnaire about Physical Activity (International Physical Activity Questionnaire) will be placed in a logistic regression model, whose aim will be to investigate the influence of amount of Physical activity (predictor) on the success of non surgical periodontal treatment (treat to target; dependent variable). Physical activity is evaluated on a scale between 0 and 2 (0= low physical activity; 1= moderate physical activity; 2= intense physical activity).
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)
Time Frame: outcome measured at reevaluation (3 months after the completion of non-surgical periodontal treatment)
results obtained from the questionnaire about Perceived stress (Italian Perceived Stress Scale) will be placed in a logistic regression model, whose aim will be to investigate the influence of perceived stress (predictor) on the success of non surgical periodontal treatment (treat to target; dependent variable). Perceived Stress is evaluated on a scale between 0 and 40; the higher the score, the higher the stress perceived.
outcome measured at reevaluation (3 months after the completion of non-surgical periodontal treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Siena

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 16, 2021

Primary Completion (Anticipated)

August 20, 2021

Study Completion (Anticipated)

November 25, 2021

Study Registration Dates

First Submitted

February 16, 2021

First Submitted That Met QC Criteria

February 23, 2021

First Posted (Actual)

February 24, 2021

Study Record Updates

Last Update Posted (Actual)

February 24, 2021

Last Update Submitted That Met QC Criteria

February 23, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NST001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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