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

NCT04769622 | Unknown

• 1 other identifier: NST001
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 1

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.

Conditions

Non Surgical Periodontal Treatment; Periodontitis; Periodontal Diseases

Keywords

periodontitis; non surgical periodontal treatment

Outcome Measures

Primary Outcomes (1)

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

  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 Outcomes (4)

• 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)

• 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)

Study Arms (1)

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; Other: Questionnaires

Interventions

Non-surgical periodontal treatment PROCEDURE

all included patients will be subjected to non-surgical periodontal therapy

patients affected by untreated Periodontitis

Questionnaires OTHER

All patients will be asked to complete a set of questionnaires regarding: * adherence to Mediterranean Diet; * sleep quality; * physical activity; * perceived stress.

patients affected by untreated Periodontitis

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Siena: lead

Study Sites (1)

AOUS

Siena, 53100, Italy

RECRUITING

MeSH Terms

Conditions

Periodontitis; Periodontal Diseases

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Nicola Discepoli, DDS, MsC, PhD

CONTACT

0577585772; nicola.discepoli2@unisi.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: February 16, 2021
• First Posted: February 24, 2021
• Study Start: February 16, 2021
• Primary Completion: August 20, 2021
• Study Completion: November 25, 2021
• Last Updated: February 24, 2021

Record last verified: 2021-02

Locations

IT (1)